Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-31 @ 10:17 AM
Study NCT ID:
NCT01465334
Status:
TERMINATED
Last Update Posted:
2023-08-29
First Post:
2011-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ofatumumab With High Dose Methylprednisone Followed by Ofatumumab and Alemtuzumab in 17p CLL
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C527517', 'term': 'ofatumumab'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D000074323', 'term': 'Alemtuzumab'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Jennifer_Brown@dfci.harvard.edu', 'phone': '(617) 632-3316', 'title': 'Jennifer R. Brown, MD, PhD', 'organization': 'Dana-Farber Cancer Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) were collected weekly during cycle 1 Part A and then every other week for the duration of Part A (up to 16 weeks); every cycle for the duration of Part B (up to 24 weeks); and every 56 days for the duration of Part C (up to 104 weeks). AEs in summary were collected up to 144 weeks of treatment plus 30 days.', 'description': 'Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. Grades 1-2 AEs were not required reporting per protocol; all AEs collected were included in the calculation. No further data is available to specify classification of system organ class "Other" per CTCAEv4 criteria beyond the general term.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Naive', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy.\n\n(cycle duration=28 days)\n\nPart A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants who have not experienced a clinical complete response with no residual detectable disease after Part A will continue on to Part B.\n\nPart B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants who have experienced at least stable disease in Parts A and B can continue on to Part C. Participants who are eligible may instead proceed to stem cell transplantation after Parts A and B.\n\nPart C: Maintenance with Ofatumumab + Alemtuzumab up to 2 years Ofatumumab: 1000 mg IV every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'deathsNumAffected': 7, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Relapsed/Refractory', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy.\n\n(cycle duration=28 days)\n\nPart A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants who have not experienced a clinical complete response with no residual detectable disease after Part A will continue on to Part B.\n\nPart B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants who have experienced at least stable disease in Parts A and B can continue on to Part C. Participants who are eligible may instead proceed to stem cell transplantation after Parts A and B.\n\nPart C: Maintenance with Ofatumumab + Alemtuzumab up to 2 years Ofatumumab: 1000 mg IV every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 14, 'seriousNumAtRisk': 15, 'deathsNumAffected': 6, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Blood and lymphatic system disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Bullous dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cardiac disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Chest pain - cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Chest wall pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Colonic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Duodenal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Ear and labyrinth disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Ear and labyrinth disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Edema face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Edema limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Edema trunk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Eye disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Flashing lights', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Gastrointestinal disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'General disorders and administration site conditions - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Generalized muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypermagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypernatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperuricemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypocalcemia', 'stats': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Growth hormone abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lymphocyte count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Treatment related secondary malignancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Induction Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):\n\nInduction Part A: Ofatumumab + HDMP 2-4 cycles\n\nOfatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22\n\nHigh-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.\n\nInduction Part B: Ofatumumab + Alemtuzumab 1-6 cycles\n\nOfatumumab: 1000 mg IV Day 1\n\nAlemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.\n\nMaintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles\n\nOfatumumab: 1000 mg IV Day 1 every other cycle\n\nAlemtuzumab: 30 mg subcutaneously Days 14, 28'}, {'id': 'OG001', 'title': 'Relapsed/Refractory', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):\n\nInduction Part A: Ofatumumab + HDMP 2-4 cycles\n\nOfatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22\n\nHigh-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.\n\nInduction Part B: Ofatumumab + Alemtuzumab 1-6 cycles\n\nOfatumumab: 1000 mg IV Day 1\n\nAlemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.\n\nMaintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles\n\nOfatumumab: 1000 mg IV Day 1 every other cycle\n\nAlemtuzumab: 30 mg subcutaneously Days 14, 28'}], 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000', 'lowerLimit': '49', 'upperLimit': '90'}, {'value': '60', 'groupId': 'OG001', 'lowerLimit': '36', 'upperLimit': '81'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Disease was evaluated after weeks 8 and 16 of Part A and at 12, 18 and 24 weeks during part B.', 'description': 'Induction ORR is the percentage of participants achieving a minimum of partial response (PR) over induction treatment based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. PR is a 50% or greater decrease of measured size of lymphadenopathy, hepatomegaly, splenomegaly as well as blood lymphocytes (over baseline), marrow infiltrate or B-lymphoid nodules and a 50% or greater increase from baseline in platelet count (or level \\>100,000/micro liter), hemoglobin (or level \\>11 grams/deciliter), neutrophils (or level \\>1500/microliter).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Induction Complete Response (CR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):\n\nInduction Part A: Ofatumumab + HDMP 2-4 cycles\n\nOfatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22\n\nHigh-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.\n\nInduction Part B: Ofatumumab + Alemtuzumab 1-6 cycles\n\nOfatumumab: 1000 mg IV Day 1\n\nAlemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.\n\nMaintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles\n\nOfatumumab: 1000 mg IV Day 1 every other cycle\n\nAlemtuzumab: 30 mg subcutaneously Days 14, 28'}, {'id': 'OG001', 'title': 'Relapsed/Refractory', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):\n\nInduction Part A: Ofatumumab + HDMP 2-4 cycles\n\nOfatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22\n\nHigh-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.\n\nInduction Part B: Ofatumumab + Alemtuzumab 1-6 cycles\n\nOfatumumab: 1000 mg IV Day 1\n\nAlemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.\n\nMaintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles\n\nOfatumumab: 1000 mg IV Day 1 every other cycle\n\nAlemtuzumab: 30 mg subcutaneously Days 14, 28'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Disease was evaluated after weeks 8 and 16 of Part A and at 12, 18 and 24 weeks during part B.', 'description': 'CR over induction treatment was based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. CR is absence of significant lymphadenopathy (nodes\\<1.5 centimeters in long axis diameter), hepatomegaly, splenomegaly as well as blood lymphocytes\\<4000/microliter, normocellular for age marrow with \\<30% lymphocytes, no B-lymphoid nodules and platelet\\>100,000/micro liter, hemoglobin\\>11 grams/deciliter, neutrophils\\>1500/microliter.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):\n\nInduction Part A: Ofatumumab + HDMP 2-4 cycles\n\nOfatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22\n\nHigh-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.\n\nInduction Part B: Ofatumumab + Alemtuzumab 1-6 cycles\n\nOfatumumab: 1000 mg IV Day 1\n\nAlemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.\n\nMaintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles\n\nOfatumumab: 1000 mg IV Day 1 every other cycle\n\nAlemtuzumab: 30 mg subcutaneously Days 14, 28'}, {'id': 'OG001', 'title': 'Relapsed/Refractory', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):\n\nInduction Part A: Ofatumumab + HDMP 2-4 cycles\n\nOfatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22\n\nHigh-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.\n\nInduction Part B: Ofatumumab + Alemtuzumab 1-6 cycles\n\nOfatumumab: 1000 mg IV Day 1\n\nAlemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.\n\nMaintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles\n\nOfatumumab: 1000 mg IV Day 1 every other cycle\n\nAlemtuzumab: 30 mg subcutaneously Days 14, 28'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '56', 'upperLimit': '94'}, {'value': '67', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '86'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Disease was evaluated after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C.', 'description': 'Overall ORR is the percentage of participants achieving a minimum of partial response (PR) over induction and maintenance treatment based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. PR is a 50% or greater decrease of measured size of lymphadenopathy, hepatomegaly, splenomegaly as well as blood lymphocytes (over baseline), marrow infiltrate or B-lymphoid nodules and a 50% or greater increase from baseline in platelet count (or level \\>100,000/micro liter), hemoglobin (or level \\>11 grams/deciliter), neutrophils (or level \\>1500/microliter).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Overall CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):\n\nInduction Part A: Ofatumumab + HDMP 2-4 cycles\n\nOfatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22\n\nHigh-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.\n\nInduction Part B: Ofatumumab + Alemtuzumab 1-6 cycles\n\nOfatumumab: 1000 mg IV Day 1\n\nAlemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.\n\nMaintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles\n\nOfatumumab: 1000 mg IV Day 1 every other cycle\n\nAlemtuzumab: 30 mg subcutaneously Days 14, 28'}, {'id': 'OG001', 'title': 'Relapsed/Refractory', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):\n\nInduction Part A: Ofatumumab + HDMP 2-4 cycles\n\nOfatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22\n\nHigh-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.\n\nInduction Part B: Ofatumumab + Alemtuzumab 1-6 cycles\n\nOfatumumab: 1000 mg IV Day 1\n\nAlemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.\n\nMaintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles\n\nOfatumumab: 1000 mg IV Day 1 every other cycle\n\nAlemtuzumab: 30 mg subcutaneously Days 14, 28'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Disease was evaluated after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C.', 'description': 'CR overall (induction and maintenance treatment) was based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. CR is absence of significant lymphadenopathy (nodes\\<1.5 centimeters in long axis diameter), hepatomegaly, splenomegaly as well as blood lymphocytes\\<4000/microliter, normocellular for age marrow with \\<30% lymphocytes, no B-lymphoid nodules and platelet\\>100,000/micro liter, hemoglobin\\>11 grams/deciliter, neutrophils\\>1500/microliter.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall MRD Negative Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):\n\nInduction Part A: Ofatumumab + HDMP 2-4 cycles\n\nOfatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22\n\nHigh-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.\n\nInduction Part B: Ofatumumab + Alemtuzumab 1-6 cycles\n\nOfatumumab: 1000 mg IV Day 1\n\nAlemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.\n\nMaintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles\n\nOfatumumab: 1000 mg IV Day 1 every other cycle\n\nAlemtuzumab: 30 mg subcutaneously Days 14, 28'}, {'id': 'OG001', 'title': 'Relapsed/Refractory', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):\n\nInduction Part A: Ofatumumab + HDMP 2-4 cycles\n\nOfatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22\n\nHigh-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.\n\nInduction Part B: Ofatumumab + Alemtuzumab 1-6 cycles\n\nOfatumumab: 1000 mg IV Day 1\n\nAlemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.\n\nMaintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles\n\nOfatumumab: 1000 mg IV Day 1 every other cycle\n\nAlemtuzumab: 30 mg subcutaneously Days 14, 28'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '56', 'upperLimit': '94'}, {'value': '53', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '76'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'MRD was assessed after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C.', 'description': 'Overall MRD negative rate is the percentage of participants classified as MRD negative by four color flow cytometry. The assay has a sensitivity of 1 in 10,000 leukocytes.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Transplant Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):\n\nInduction Part A: Ofatumumab + HDMP 2-4 cycles\n\nOfatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22\n\nHigh-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.\n\nInduction Part B: Ofatumumab + Alemtuzumab 1-6 cycles\n\nOfatumumab: 1000 mg IV Day 1\n\nAlemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.\n\nMaintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles\n\nOfatumumab: 1000 mg IV Day 1 every other cycle\n\nAlemtuzumab: 30 mg subcutaneously Days 14, 28'}, {'id': 'OG001', 'title': 'Relapsed/Refractory', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):\n\nInduction Part A: Ofatumumab + HDMP 2-4 cycles\n\nOfatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22\n\nHigh-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.\n\nInduction Part B: Ofatumumab + Alemtuzumab 1-6 cycles\n\nOfatumumab: 1000 mg IV Day 1\n\nAlemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.\n\nMaintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles\n\nOfatumumab: 1000 mg IV Day 1 every other cycle\n\nAlemtuzumab: 30 mg subcutaneously Days 14, 28'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '67'}, {'value': '43', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '67'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Evaluated up to 36 cycles (approximately 2.75 years) of treatment (Parts A, B and C)', 'description': 'Percentage of participants eligible for allogeneic hematopoietic stem cell transplantation (alloHSCT) that are able and willing to proceed to alloHSCT.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Related Grades 1-3 Hyperglycemia During Part A Induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):\n\nInduction Part A: Ofatumumab + HDMP 2-4 cycles\n\nOfatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22\n\nHigh-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.\n\nInduction Part B: Ofatumumab + Alemtuzumab 1-6 cycles\n\nOfatumumab: 1000 mg IV Day 1\n\nAlemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.\n\nMaintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles\n\nOfatumumab: 1000 mg IV Day 1 every other cycle\n\nAlemtuzumab: 30 mg subcutaneously Days 14, 28'}, {'id': 'OG001', 'title': 'Relapsed/Refractory', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):\n\nInduction Part A: Ofatumumab + HDMP 2-4 cycles\n\nOfatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22\n\nHigh-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.\n\nInduction Part B: Ofatumumab + Alemtuzumab 1-6 cycles\n\nOfatumumab: 1000 mg IV Day 1\n\nAlemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.\n\nMaintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles\n\nOfatumumab: 1000 mg IV Day 1 every other cycle\n\nAlemtuzumab: 30 mg subcutaneously Days 14, 28'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Adverse Events (AEs) were collected weekly during cycle 1 Part A and then every other week for the duration of Part A (up to 16 weeks)', 'description': 'Participants ever experiencing a grade 1-3 hyperglycemia event based on CTCAEv4 with treatment attribution of possible, probably or definite as reported on case report forms were counted.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '3-Year Progression-Free Survival (PFS) Probability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):\n\nInduction Part A: Ofatumumab + HDMP 2-4 cycles\n\nOfatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22\n\nHigh-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.\n\nInduction Part B: Ofatumumab + Alemtuzumab 1-6 cycles\n\nOfatumumab: 1000 mg IV Day 1\n\nAlemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.\n\nMaintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles\n\nOfatumumab: 1000 mg IV Day 1 every other cycle\n\nAlemtuzumab: 30 mg subcutaneously Days 14, 28'}, {'id': 'OG001', 'title': 'Relapsed/Refractory', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):\n\nInduction Part A: Ofatumumab + HDMP 2-4 cycles\n\nOfatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22\n\nHigh-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.\n\nInduction Part B: Ofatumumab + Alemtuzumab 1-6 cycles\n\nOfatumumab: 1000 mg IV Day 1\n\nAlemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.\n\nMaintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles\n\nOfatumumab: 1000 mg IV Day 1 every other cycle\n\nAlemtuzumab: 30 mg subcutaneously Days 14, 28'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '74'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '49'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Disease was evaluated on treatment after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C as well as off-treatment every 3 months up to 5 years.', 'description': '3-year PFS is the probability of participants remaining alive and progression-free at 3 years from study entry estimated using Kaplan-Meier methods. Disease progression (PD) per International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008) is: the appearance of any new lesion (enlarged lymph node minimum \\>1.5 centimeters); an increase by 50% in greatest determined diameter of any previous site; an increase in the previously noted enlargement of the liver or spleen by 50% or more or the de novo appearance of hepatomegaly, splenomegaly; a 50% increase of blood lymphocytes (over baseline with level at least 5,000/microliter); occurrence of cytopenia secondary to CLL at least 3 months post treatment including a 50% or greater decrease from baseline in platelet count (or level \\<100,000/microliter) or a hemoglobin decrease of \\>2 grams/deciliter (or level \\<10 grams/deciliter); and transformation to a more aggressive histology.', 'unitOfMeasure': 'percentage probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '3-year Overall Survival (OS) Probability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):\n\nInduction Part A: Ofatumumab + HDMP 2-4 cycles\n\nOfatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22\n\nHigh-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.\n\nInduction Part B: Ofatumumab + Alemtuzumab 1-6 cycles\n\nOfatumumab: 1000 mg IV Day 1\n\nAlemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.\n\nMaintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles\n\nOfatumumab: 1000 mg IV Day 1 every other cycle\n\nAlemtuzumab: 30 mg subcutaneously Days 14, 28'}, {'id': 'OG001', 'title': 'Relapsed/Refractory', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):\n\nInduction Part A: Ofatumumab + HDMP 2-4 cycles\n\nOfatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22\n\nHigh-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.\n\nInduction Part B: Ofatumumab + Alemtuzumab 1-6 cycles\n\nOfatumumab: 1000 mg IV Day 1\n\nAlemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.\n\nMaintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles\n\nOfatumumab: 1000 mg IV Day 1 every other cycle\n\nAlemtuzumab: 30 mg subcutaneously Days 14, 28'}], 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000', 'lowerLimit': '36', 'upperLimit': '84'}, {'value': '53', 'groupId': 'OG001', 'lowerLimit': '26', 'upperLimit': '74'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Median survival follow-up was 45 months (range 31-58 months) in this study cohort.', 'description': '3-year OS is the probability of participants remaining alive at 3 years from study entry estimated using Kaplan-Meier methods.', 'unitOfMeasure': 'percentage probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Completing Part A Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):\n\nInduction Part A: Ofatumumab + HDMP 2-4 cycles\n\nOfatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22\n\nHigh-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.\n\nInduction Part B: Ofatumumab + Alemtuzumab 1-6 cycles\n\nOfatumumab: 1000 mg IV Day 1\n\nAlemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.\n\nMaintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles\n\nOfatumumab: 1000 mg IV Day 1 every other cycle\n\nAlemtuzumab: 30 mg subcutaneously Days 14, 28'}, {'id': 'OG001', 'title': 'Relapsed/Refractory', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):\n\nInduction Part A: Ofatumumab + HDMP 2-4 cycles\n\nOfatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22\n\nHigh-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.\n\nInduction Part B: Ofatumumab + Alemtuzumab 1-6 cycles\n\nOfatumumab: 1000 mg IV Day 1\n\nAlemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.\n\nMaintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles\n\nOfatumumab: 1000 mg IV Day 1 every other cycle\n\nAlemtuzumab: 30 mg subcutaneously Days 14, 28'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Evaluated up to 4 cycles/16 weeks.', 'description': 'Participants counted as completing Part A with either 2 or 4 cycles of treatment per protocol.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Completing Only 2 Cycles of Part A Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):\n\nInduction Part A: Ofatumumab + HDMP 2-4 cycles\n\nOfatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22\n\nHigh-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.\n\nInduction Part B: Ofatumumab + Alemtuzumab 1-6 cycles\n\nOfatumumab: 1000 mg IV Day 1\n\nAlemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.\n\nMaintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles\n\nOfatumumab: 1000 mg IV Day 1 every other cycle\n\nAlemtuzumab: 30 mg subcutaneously Days 14, 28'}, {'id': 'OG001', 'title': 'Relapsed/Refractory', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):\n\nInduction Part A: Ofatumumab + HDMP 2-4 cycles\n\nOfatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22\n\nHigh-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.\n\nInduction Part B: Ofatumumab + Alemtuzumab 1-6 cycles\n\nOfatumumab: 1000 mg IV Day 1\n\nAlemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.\n\nMaintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles\n\nOfatumumab: 1000 mg IV Day 1 every other cycle\n\nAlemtuzumab: 30 mg subcutaneously Days 14, 28'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Evaluated after 2 cycles/8 weeks of Part A therapy.', 'description': 'Participants counted if only completed 2 cycles of Part A treatment per protocol.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Naive', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):\n\nInduction Part A: Ofatumumab + HDMP 2-4 cycles\n\nOfatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22\n\nHigh-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.\n\nInduction Part B: Ofatumumab + Alemtuzumab 1-6 cycles\n\nOfatumumab: 1000 mg IV Day 1\n\nAlemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.\n\nMaintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles\n\nOfatumumab: 1000 mg IV Day 1 every other cycle\n\nAlemtuzumab: 30 mg subcutaneously Days 14, 28'}, {'id': 'FG001', 'title': 'Relapsed/Refractory', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):\n\nInduction Part A: Ofatumumab + HDMP 2-4 cycles\n\nOfatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22\n\nHigh-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.\n\nInduction Part B: Ofatumumab + Alemtuzumab 1-6 cycles\n\nOfatumumab: 1000 mg IV Day 1\n\nAlemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.\n\nMaintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles\n\nOfatumumab: 1000 mg IV Day 1 every other cycle\n\nAlemtuzumab: 30 mg subcutaneously Days 14, 28'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Complete Part A Induction', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Complete Part B Induction', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Eligible for Allogeneic Transplant', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': "Richter's transformation", 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Refractory Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Participants enrolled between December 2011 and November 2014.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Naive', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):\n\nInduction Part A: Ofatumumab + HDMP 2-4 cycles\n\nOfatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22\n\nHigh-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.\n\nInduction Part B: Ofatumumab + Alemtuzumab 1-6 cycles\n\nOfatumumab: 1000 mg IV Day 1\n\nAlemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.\n\nMaintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles\n\nOfatumumab: 1000 mg IV Day 1 every other cycle\n\nAlemtuzumab: 30 mg subcutaneously Days 14, 28'}, {'id': 'BG001', 'title': 'Relapsed/Refractory', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):\n\nInduction Part A: Ofatumumab + HDMP 2-4 cycles\n\nOfatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22\n\nHigh-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.\n\nInduction Part B: Ofatumumab + Alemtuzumab 1-6 cycles\n\nOfatumumab: 1000 mg IV Day 1\n\nAlemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.\n\nMaintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles\n\nOfatumumab: 1000 mg IV Day 1 every other cycle\n\nAlemtuzumab: 30 mg subcutaneously Days 14, 28'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000', 'lowerLimit': '45', 'upperLimit': '86'}, {'value': '65', 'groupId': 'BG001', 'lowerLimit': '58', 'upperLimit': '80'}, {'value': '65', 'groupId': 'BG002', 'lowerLimit': '45', 'upperLimit': '86'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Prior Therapies', 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': '3', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'At study entry, participants were classified based on number of prior therapies: treatment naive=0; relapsed/refractory\\>0.', 'unitOfMeasure': 'Participants'}, {'title': 'Time from Diagnosis to First Therapy', 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'groupId': 'BG000', 'lowerLimit': '0.9', 'upperLimit': '52.6'}, {'value': '23', 'groupId': 'BG001', 'lowerLimit': '0.1', 'upperLimit': '110'}, {'value': '12.4', 'groupId': 'BG002', 'lowerLimit': '0.1', 'upperLimit': '110'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'FULL_RANGE'}, {'title': 'Time from Diagnosis to Start on Trial', 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'groupId': 'BG000', 'lowerLimit': '0.8', 'upperLimit': '52.6'}, {'value': '59.4', 'groupId': 'BG001', 'lowerLimit': '1.6', 'upperLimit': '233'}, {'value': '27.6', 'groupId': 'BG002', 'lowerLimit': '0.8', 'upperLimit': '233'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'FULL_RANGE'}, {'title': 'Whole Exome Sequencing-Mutations', 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000', 'lowerLimit': '7', 'upperLimit': '27'}, {'value': '20', 'groupId': 'BG001', 'lowerLimit': '15', 'upperLimit': '45'}, {'value': '21', 'groupId': 'BG002', 'lowerLimit': '7', 'upperLimit': '45'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mutations', 'dispersionType': 'FULL_RANGE'}, {'title': 'Whole Exome Sequencing-Copy Number Alterations', 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'BG000', 'lowerLimit': '4', 'upperLimit': '33'}, {'value': '14', 'groupId': 'BG001', 'lowerLimit': '3', 'upperLimit': '45'}, {'value': '14', 'groupId': 'BG002', 'lowerLimit': '3', 'upperLimit': '45'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Events', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'The analysis dataset is comprised of all treated participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'Terminated early due to change in practice.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-28', 'studyFirstSubmitDate': '2011-10-18', 'resultsFirstSubmitDate': '2019-05-16', 'studyFirstSubmitQcDate': '2011-11-02', 'lastUpdatePostDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-06', 'studyFirstPostDateStruct': {'date': '2011-11-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Induction Overall Response Rate (ORR)', 'timeFrame': 'Disease was evaluated after weeks 8 and 16 of Part A and at 12, 18 and 24 weeks during part B.', 'description': 'Induction ORR is the percentage of participants achieving a minimum of partial response (PR) over induction treatment based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. PR is a 50% or greater decrease of measured size of lymphadenopathy, hepatomegaly, splenomegaly as well as blood lymphocytes (over baseline), marrow infiltrate or B-lymphoid nodules and a 50% or greater increase from baseline in platelet count (or level \\>100,000/micro liter), hemoglobin (or level \\>11 grams/deciliter), neutrophils (or level \\>1500/microliter).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Achieving Induction Complete Response (CR)', 'timeFrame': 'Disease was evaluated after weeks 8 and 16 of Part A and at 12, 18 and 24 weeks during part B.', 'description': 'CR over induction treatment was based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. CR is absence of significant lymphadenopathy (nodes\\<1.5 centimeters in long axis diameter), hepatomegaly, splenomegaly as well as blood lymphocytes\\<4000/microliter, normocellular for age marrow with \\<30% lymphocytes, no B-lymphoid nodules and platelet\\>100,000/micro liter, hemoglobin\\>11 grams/deciliter, neutrophils\\>1500/microliter.'}, {'measure': 'Overall Objective Response Rate (ORR)', 'timeFrame': 'Disease was evaluated after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C.', 'description': 'Overall ORR is the percentage of participants achieving a minimum of partial response (PR) over induction and maintenance treatment based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. PR is a 50% or greater decrease of measured size of lymphadenopathy, hepatomegaly, splenomegaly as well as blood lymphocytes (over baseline), marrow infiltrate or B-lymphoid nodules and a 50% or greater increase from baseline in platelet count (or level \\>100,000/micro liter), hemoglobin (or level \\>11 grams/deciliter), neutrophils (or level \\>1500/microliter).'}, {'measure': 'Number of Participants With Overall CR', 'timeFrame': 'Disease was evaluated after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C.', 'description': 'CR overall (induction and maintenance treatment) was based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. CR is absence of significant lymphadenopathy (nodes\\<1.5 centimeters in long axis diameter), hepatomegaly, splenomegaly as well as blood lymphocytes\\<4000/microliter, normocellular for age marrow with \\<30% lymphocytes, no B-lymphoid nodules and platelet\\>100,000/micro liter, hemoglobin\\>11 grams/deciliter, neutrophils\\>1500/microliter.'}, {'measure': 'Overall MRD Negative Rate', 'timeFrame': 'MRD was assessed after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C.', 'description': 'Overall MRD negative rate is the percentage of participants classified as MRD negative by four color flow cytometry. The assay has a sensitivity of 1 in 10,000 leukocytes.'}, {'measure': 'Transplant Rate', 'timeFrame': 'Evaluated up to 36 cycles (approximately 2.75 years) of treatment (Parts A, B and C)', 'description': 'Percentage of participants eligible for allogeneic hematopoietic stem cell transplantation (alloHSCT) that are able and willing to proceed to alloHSCT.'}, {'measure': 'Number of Participants With Treatment-Related Grades 1-3 Hyperglycemia During Part A Induction', 'timeFrame': 'Adverse Events (AEs) were collected weekly during cycle 1 Part A and then every other week for the duration of Part A (up to 16 weeks)', 'description': 'Participants ever experiencing a grade 1-3 hyperglycemia event based on CTCAEv4 with treatment attribution of possible, probably or definite as reported on case report forms were counted.'}, {'measure': '3-Year Progression-Free Survival (PFS) Probability', 'timeFrame': 'Disease was evaluated on treatment after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C as well as off-treatment every 3 months up to 5 years.', 'description': '3-year PFS is the probability of participants remaining alive and progression-free at 3 years from study entry estimated using Kaplan-Meier methods. Disease progression (PD) per International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008) is: the appearance of any new lesion (enlarged lymph node minimum \\>1.5 centimeters); an increase by 50% in greatest determined diameter of any previous site; an increase in the previously noted enlargement of the liver or spleen by 50% or more or the de novo appearance of hepatomegaly, splenomegaly; a 50% increase of blood lymphocytes (over baseline with level at least 5,000/microliter); occurrence of cytopenia secondary to CLL at least 3 months post treatment including a 50% or greater decrease from baseline in platelet count (or level \\<100,000/microliter) or a hemoglobin decrease of \\>2 grams/deciliter (or level \\<10 grams/deciliter); and transformation to a more aggressive histology.'}, {'measure': '3-year Overall Survival (OS) Probability', 'timeFrame': 'Median survival follow-up was 45 months (range 31-58 months) in this study cohort.', 'description': '3-year OS is the probability of participants remaining alive at 3 years from study entry estimated using Kaplan-Meier methods.'}, {'measure': 'Number of Participants Completing Part A Treatment', 'timeFrame': 'Evaluated up to 4 cycles/16 weeks.', 'description': 'Participants counted as completing Part A with either 2 or 4 cycles of treatment per protocol.'}, {'measure': 'Number of Participants Completing Only 2 Cycles of Part A Treatment', 'timeFrame': 'Evaluated after 2 cycles/8 weeks of Part A therapy.', 'description': 'Participants counted if only completed 2 cycles of Part A treatment per protocol.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['17p Deletion CLL'], 'conditions': ['CLL', 'SLL']}, 'referencesModule': {'references': [{'pmid': '30322319', 'type': 'RESULT', 'citation': 'Davids MS, Kim HT, Yu L, De Maeyer G, McDonough M, Vartanov AR, Langey R, Fernandes SM, Hellman JM, Francoeur K, Arnason J, Jacobsen ED, LaCasce AS, Fisher DC, Brown JR. Ofatumumab plus high dose methylprednisolone followed by ofatumumab plus alemtuzumab to achieve maximal cytoreduction prior to allogeneic transplantation for 17p deleted or TP53 mutated chronic lymphocytic leukemia. Leuk Lymphoma. 2019 May;60(5):1312-1315. doi: 10.1080/10428194.2018.1519814. Epub 2018 Oct 15.'}]}, 'descriptionModule': {'briefSummary': "The main purpose of this study is to examine how two separate groups of 17p deletion Chronic lymphocytic leukemia (CLL) participants respond to sequential treatment with this particular combination of drugs. The two groups are those participants who have previously received treatment for their CLL and those who have not yet received any treatment. The combination of drugs is Ofatumumab and High-Dose Methylprednisolone (HDMP) first followed by Ofatumumab and Alemtuzumab. All three drugs are FDA approved and have known activity in treating 17p CLL. We hope that by combining these drugs together in this study, they will have more benefit than each one alone and that the subjects' CLL will be significantly impacted.", 'detailedDescription': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy.\n\nPart A: Ofatumumab + HDMP 2-4 cycles Part B: Ofatumumab + Alemtuzumab 1-6 cycles Part C: Maintenance with Ofatumumab + Alemtuzumab up to 2 years\n\nBetween days 15-22 of Cycle 2 of Part A, participants are restaged. Participants who achieve nodal complete response discontinue Part A therapy and undergo minimal residual disease (MRD) assessment to guide the decision whether to go to Part B or Part C. The participants with persistent disease after 2 cycles of Part A therapy receive 2 more cycles of Part A therapy and then undergo another restaging as well as MRD assessment. At restaging, participants with minimal disease are eligible for Part C or allogeneic stem cell transplant (SCT) off protocol. The remaining participants receive Part B therapy. On Part B, restaging occurs at weeks 12 and 18. If MRD negative complete response (CR) status is achieved then therapy is discontinued and the primary endpoint evaluation occurs 2 months later. Otherwise with persistent disease Part B therapy continues up to 24 weeks and the primary endpoint evaluation occurs after Part B therapy is completed. Participants who achieve clinical complete response may receive Part C therapy or be observed while waiting SCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented CLL/SLL\n* 17p deletion by FISH in 20% or more nuclei on peripheral blood, bone marrow or lymph node\n* Normal organ function\n\nExclusion Criteria:\n\n* Pregnant or breast feeding\n* Current active hepatic or biliary disease\n* Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, tuberculosis and active Hepatitis C\n* History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae\n* Other past or current malignancy. Participants who have been free of malignancy for at least 2 years, or who have a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.\n* Known HIV positive\n* Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months prior to study entry, congestive heart failure, and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities.\n* Significant concurrent uncontrolled medical conditions including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the subject.\n* Positive serology for Hepatitis B or C\n* History of allergic reactions attributed to ofatumumab.'}, 'identificationModule': {'nctId': 'NCT01465334', 'briefTitle': 'Ofatumumab With High Dose Methylprednisone Followed by Ofatumumab and Alemtuzumab in 17p CLL', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'A Phase II Study of Ofatumumab-High Dose Methylprednisolone Followed by Ofatumumab-Alemtuzumab in 17p Deletion CLL', 'orgStudyIdInfo': {'id': '11-304'}, 'secondaryIdInfos': [{'id': 'NCCN Protocol Number: NCCN-001', 'type': 'OTHER_GRANT', 'domain': 'NCCN'}, {'id': 'GSK Protocol Number: OFT115580', 'type': 'OTHER', 'domain': 'GSK'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Naive', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):\n\nInduction Part A: Ofatumumab + HDMP 2-4 cycles\n\nOfatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22\n\nHigh-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.\n\nInduction Part B: Ofatumumab + Alemtuzumab 1-6 cycles\n\nOfatumumab: 1000 mg IV Day 1\n\nAlemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.\n\nMaintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles\n\nOfatumumab: 1000 mg IV Day 1 every other cycle\n\nAlemtuzumab: 30 mg subcutaneously Days 14, 28', 'interventionNames': ['Drug: Ofatumumab', 'Drug: High-Dose Methylprednisolone', 'Drug: Alemtuzumab']}, {'type': 'EXPERIMENTAL', 'label': 'Relapsed/Refractory', 'description': 'Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):\n\nInduction Part A: Ofatumumab + HDMP 2-4 cycles\n\nOfatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22\n\nHigh-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3\n\nParticipants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.\n\nInduction Part B: Ofatumumab + Alemtuzumab 1-6 cycles\n\nOfatumumab: 1000 mg IV Day 1\n\nAlemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26\n\nParticipants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.\n\nMaintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles\n\nOfatumumab: 1000 mg IV Day 1 every other cycle\n\nAlemtuzumab: 30 mg subcutaneously Days 14, 28', 'interventionNames': ['Drug: Ofatumumab', 'Drug: High-Dose Methylprednisolone', 'Drug: Alemtuzumab']}], 'interventions': [{'name': 'Ofatumumab', 'type': 'DRUG', 'otherNames': ['GSK 1841157'], 'armGroupLabels': ['Relapsed/Refractory', 'Treatment Naive']}, {'name': 'High-Dose Methylprednisolone', 'type': 'DRUG', 'otherNames': ['HDMP'], 'armGroupLabels': ['Relapsed/Refractory', 'Treatment Naive']}, {'name': 'Alemtuzumab', 'type': 'DRUG', 'otherNames': ['Campath-1H'], 'armGroupLabels': ['Relapsed/Refractory', 'Treatment Naive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Jennifer R Brown, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Comprehensive Cancer Network', 'class': 'NETWORK'}, {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jennifer R. Brown, MD, PhD', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}