Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2025-12-29 @ 4:10 PM
Study NCT ID:
NCT00895661
Status:
COMPLETED
Last Update Posted:
2017-06-09
First Post:
2009-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
High Dose Rituximab for Initial Treatment of Indolent B-Cell Lymphomas
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'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': 'jabramson@mgh.harvard.edu', 'phone': '617-724-4000', 'title': 'Jeremy Abramson, MD', 'organization': 'Massachusetts General Hospital Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Rituximab', 'description': 'single-arm, open-label, interventional\n\nrituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2).', 'otherNumAtRisk': 40, 'otherNumAffected': 40, 'seriousNumAtRisk': 40, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Neutrophils', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 495, 'numAffected': 40}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 493, 'numAffected': 40}], 'organSystem': 'Immune system disorders'}, {'term': 'Infection-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 493, 'numAffected': 40}], 'organSystem': 'Infections and infestations'}, {'term': 'Tumor lysis syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 493, 'numAffected': 40}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 97, 'numAffected': 24}], 'organSystem': 'General disorders'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 34, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 52, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 38, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Diarrhea w/o prior colostomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 32, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Leukocytes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 32, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Rash/desquamation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 19, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Infection Gr0-2 neut- upper airway', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Infections and infestations'}, {'term': 'Fever w/o neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'General disorders'}, {'term': 'Abdomen- pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 21, 'numAffected': 9}], 'organSystem': 'General disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 21, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 19, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 21, 'numAffected': 8}], 'organSystem': 'Nervous system disorders'}, {'term': 'Allergic rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 20, 'numAffected': 8}], 'organSystem': 'Immune system disorders'}, {'term': 'Head/headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 20, 'numAffected': 8}], 'organSystem': 'General disorders'}, {'term': 'Sweating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 19, 'numAffected': 8}], 'organSystem': 'General disorders'}, {'term': 'Skin-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 16, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Back-pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'General disorders'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 15, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Pain-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'General disorders'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 27, 'numAffected': 6}], 'organSystem': 'General disorders'}, {'term': 'Pelvic-pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 15, 'numAffected': 6}], 'organSystem': 'General disorders'}, {'term': 'Joint-pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 14, 'numAffected': 6}], 'organSystem': 'General disorders'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 18, 'numAffected': 5}], 'organSystem': 'Nervous system disorders'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 13, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'AST- SGOT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Infection Gr0-2 neut- bronchus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations'}, {'term': 'Rigors/chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders'}, {'term': 'Neuropathy-sensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 18, 'numAffected': 4}], 'organSystem': 'Nervous system disorders'}, {'term': 'Alkaline phosphatase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 13, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'ALT- SGPT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 10, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Extremity-limb- pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 10, 'numAffected': 4}], 'organSystem': 'General disorders'}, {'term': 'Rash: acne/acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 9, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Infection Gr0-2 neut- sinus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Infections and infestations'}, {'term': 'Neck- pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'General disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Hyperuricemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 9, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Urinary frequency/urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 8, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'GI-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Hearing-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Edema head and neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Hematologic-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Pulmonary/Upper Respiratory-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Bronchospasm- wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Chest/thoracic pain NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'Muscle- pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'Flu-like syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Musculoskeletal/soft tissue-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 9, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 9, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 8, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 7, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Muco/stomatitis (symptom) oral cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Hyopthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Endocrine disorders'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Infection Gr0-2 neut- skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Infection Gr0-2 neut- urinary tract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Otitis- middle ear (non-infectious)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Taste disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Chest wall- pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Edema limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Infection Gr0-2 neut- lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Metabolic/Laboratory-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Ocular-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders'}, {'term': 'Voice changes/dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders'}], 'seriousEvents': [{'term': 'Decubitus ulcer', 'notes': 'grade 3, unexpected and unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Small bowel obstruction', 'notes': 'grade 4, unexpected and unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Cellulitis (toe)', 'notes': 'grade 3, expected and possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Hypoxia', 'notes': 'grade 3, unexpected and possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Determine Complete Response Rate (CRR) of Increased Dose Rituximab in Indolent B-cell Lymphomas', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab', 'description': 'single-arm, open-label, interventional\n\nrituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2).'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'after a median number of 8 maintenance cycles, up to 24 weeks', 'description': 'CR requires all of the following:\n\n1. Regression to normal size on CT (≤ 1.5 cm in their greatest transverse diameter for nodes ≥ 1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in their greatest transverse diameter before treatment must have decreased to \\<1 cm in their greatest transverse diameter after treatment, or by more than 75% in the sum of the products of the greatest diameters (SPD).\n2. The spleen, if considered to be enlarged before therapy on the basis of a CT scan, must have regressed in size and must not be palpable on physical examination.\n3. If bone marrow is known to be involved at the beginning, then repeat biopsy documents clearance', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab', 'description': 'single-arm, open-label, interventional\n\nrituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2).'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'after a median number of 8 maintenance cycles, up to 24 weeks', 'description': 'Complete Response (CR): see definition in primary outcome\n\nPartial Response (PR):\n\n1. ≥50% decrease in SPD of up to 6 largest dominant masses\n2. No new sites of disease or increase in the size of the other nodes, liver, or spleen.\n3. Splenic and hepatic nodules must regress by at least 50% in the SPD.\n\nOverall Response (OR) = CR + PR.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab', 'description': 'single-arm, open-label, interventional\n\nrituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2).'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'Progressive Disease (PD) or Relapsed Disease (RD):\n\n1. Appearance of a new lesion(s) \\> 1.5 cm in any axis, ≥ 50% increase in SPD of more than one node, or ≥50% increase in longest diameter of a previously identified node \\> 1 cm in short axis.\n2. \\>50% increase from nadir in the SPD of any previous lesions PFS is number of participants who have not died or had PD or RD.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Severity of Infusion Reactions, Infections and Neutropenia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab', 'description': 'single-arm, open-label, interventional\n\nrituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2).'}], 'classes': [{'title': 'Grade 3/4 neutropenia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Any allergic reactions with infusions', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 allergic reactions with infusions', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months', 'description': 'Toxicity grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rituximab', 'description': 'single-arm, open-label, interventional\n\nrituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'reason unknown', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Rituximab', 'description': 'single-arm, open-label, interventional\n\nrituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000', 'lowerLimit': '36', 'upperLimit': '88'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Lymphoma type', 'classes': [{'categories': [{'title': 'Follicular', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Marginal zone', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Small lymphocytic', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Indolent B cell, not otherwise specified', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Involvement of >4 nodal sites', 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hgb<12 g/dL', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'elevated LDH (Lactate dehydrogenase)', 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Follicular lymphoma prognostic index (FLIPI)', 'classes': [{'categories': [{'title': 'Low risk', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Intermediate risk', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'High risk', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'FLIPI score not available', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-09', 'studyFirstSubmitDate': '2009-05-06', 'resultsFirstSubmitDate': '2017-03-29', 'studyFirstSubmitQcDate': '2009-05-07', 'lastUpdatePostDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-29', 'studyFirstPostDateStruct': {'date': '2009-05-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine Complete Response Rate (CRR) of Increased Dose Rituximab in Indolent B-cell Lymphomas', 'timeFrame': 'after a median number of 8 maintenance cycles, up to 24 weeks', 'description': 'CR requires all of the following:\n\n1. Regression to normal size on CT (≤ 1.5 cm in their greatest transverse diameter for nodes ≥ 1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in their greatest transverse diameter before treatment must have decreased to \\<1 cm in their greatest transverse diameter after treatment, or by more than 75% in the sum of the products of the greatest diameters (SPD).\n2. The spleen, if considered to be enlarged before therapy on the basis of a CT scan, must have regressed in size and must not be palpable on physical examination.\n3. If bone marrow is known to be involved at the beginning, then repeat biopsy documents clearance'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'after a median number of 8 maintenance cycles, up to 24 weeks', 'description': 'Complete Response (CR): see definition in primary outcome\n\nPartial Response (PR):\n\n1. ≥50% decrease in SPD of up to 6 largest dominant masses\n2. No new sites of disease or increase in the size of the other nodes, liver, or spleen.\n3. Splenic and hepatic nodules must regress by at least 50% in the SPD.\n\nOverall Response (OR) = CR + PR.'}, {'measure': 'Progression-free Survival (PFS)', 'timeFrame': '5 years', 'description': 'Progressive Disease (PD) or Relapsed Disease (RD):\n\n1. Appearance of a new lesion(s) \\> 1.5 cm in any axis, ≥ 50% increase in SPD of more than one node, or ≥50% increase in longest diameter of a previously identified node \\> 1 cm in short axis.\n2. \\>50% increase from nadir in the SPD of any previous lesions PFS is number of participants who have not died or had PD or RD.'}, {'measure': 'Incidence of Severity of Infusion Reactions, Infections and Neutropenia', 'timeFrame': '24 months', 'description': 'Toxicity grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['rituximab'], 'conditions': ['B-cell Lymphoma', 'Indolent B-cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to see if increased doses of rituximab are safe and effective for the initial treatment of indolent B-cell lymphomas. Rituximab (Rituxan) is a type of drug called an "antibody" that specifically targets B-cell lymphoma cells, and is approved by the FDA for the treatment of indolent B-cell non-hodgkin lymphomas and certain other types of non-hodgkin lymphomas. Standard doses currently used may not be achieving maximal efficacy. Higher doses have been shown to be safe in other clinical trials, and may offer superior efficacy to the current standard dose. This trial also employs intermittent maintenance doses of rituximab at the standard dose, which has been shown to prolong remissions and survival in patients with relapsed indolent B-cell lymphomas. This trial is designed to show that higher dose rituximab plus maintenance rituximab can achieve similarly good results to chemotherapy approaches, but without chemotherapy-related toxicity.', 'detailedDescription': '* All participants will receive increased-dose rituximab through a vein in the arm once a week for 4 weeks (on Days 1, 8, 15, and 22 of the initial 28-day study cycle). This first cycle of study treatment is called the Induction Phase. If the participant responds well to the Induction Phase, they then may continue to the Maintenance Therapy Phase, where they will receive a lower dose of rituximab once every three months for up to 2 years.\n* During the Induction Phase, the following procedures will take place before the participant receives each dose of rituximab: medical review, physical exam, performance status, and ECG. Blood tests will be drawn about 30-60 minutes after the first dose of rituximab on Day 1. Samples will be drawn immediately before each dose and again 30-60 minutes after each dose on Days 1, 8, 15 and 22.\n* During the Maintenance Therapy Phase, the following procedures will take place before the participant receives each dose of rituximab: medical review, physical exam, performance status, ECG, blood tests and response assessments by CT scan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indolent B-Cell NHL of the following histologies:\n\n 1. Follicular lymphoma (grades 1-3A);\n 2. marginal zone lymphoma (extranodal, nodal or splenic):\n\n * Extranodal marginal zone lymphomas (MALT lymphomas) may not be candidates for cure with antibiotics or local radiotherapy. Patients who have failed antibiotics or local therapy are eligible for the protocol as long as they have measurable disease and are naive to chemotherapy and monoclonal antibody;\n * splenic marginal zone lymphoma patients may have received prior splenectomy as long as they have measureable disease and are naive to chemotherapy and monoclonal antibody therapy;\n 3. Small lymphocytic lymphoma (must have less than 5000 circulating clonal B-lymphocytes);\n 4. Indolent CD20+ B-cell lymphoma not otherwise specified with CD20+ expression\n* Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as 20mm or greater with conventional techniques or as 10mm or greater with spiral CT scan\n* No previous chemotherapy, antibody therapy or radioimmunotherapy for NHL. Patients previously treated with external bean radiation alone, surgery, or with antibiotics are eligible\n* 18 years of age or older\n* Life expectancy of greater than 3 months\n* ECOG performance status of 2 or less\n* Adequate bone marrow function\n* Use of adequate contraception\n\nExclusion Criteria:\n\n* Prior chemotherapy, monoclonal antibody therapy or radioimmunotherapy for lymphoma\n* Receiving any other investigational agent\n* Known brain metastases\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to rituximab\n* HIV positivity\n* Active hepatitis B infection\n* Candidate for curative radiotherapy, unless radiation therapy is considered too toxic (as in abdominal disease), or is refused by the patient\n* NYHA Classification III or IV disease\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection that is not optimally treated with antibiotics, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements\n* Pregnant women\n* Individuals with a history of a different malignancy except for the following circumstances:\n\n 1. disease-free for at least 1 year and are deemed by the investigator to be at low risk for recurrence of that malignancy;\n 2. localized prostate cancer, prostate cancer with elevated PSA but no measurable disease on CT scans or bone scan, cervical cancer in situ; and\n 3. non-melanoma skin cancers'}, 'identificationModule': {'nctId': 'NCT00895661', 'briefTitle': 'High Dose Rituximab for Initial Treatment of Indolent B-Cell Lymphomas', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Phase II Trial of Increased Dose Rituximab Plus Maintenance Rituximab for Initial Systemic Treatment of Indolent B-Cell Lymphomas', 'orgStudyIdInfo': {'id': '09-054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'rituximab', 'description': 'single-arm, open-label, interventional', 'interventionNames': ['Drug: rituximab']}], 'interventions': [{'name': 'rituximab', 'type': 'DRUG', 'otherNames': ['Rituxan'], 'description': 'Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2).', 'armGroupLabels': ['rituximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Jeremy Abramson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Lymphoma Program', 'investigatorFullName': 'Jeremy Abramson, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}