Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-28 @ 12:10 AM
Study NCT ID:
NCT01239394
Status:
COMPLETED
Last Update Posted:
2017-10-18
First Post:
2010-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ofatumumab for Initial Systemic Treatment of Indolent B-cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, 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'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C527517', 'term': 'ofatumumab'}]}}, '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': 'Ofatumumab', 'description': 'single-arm, open-label, interventional\n\nofatumumab: Weekly infusion for 8 weeks', 'otherNumAtRisk': 42, 'otherNumAffected': 38, 'seriousNumAtRisk': 42, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 30, 'numAffected': 28}], 'organSystem': 'Immune system disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 21, 'numAffected': 19}], 'organSystem': 'General disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Infusion related react', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Platelet count decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Blood bilirubin increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Skin and subcutaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Alanine aminotransferase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Investigations'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Bladder infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Neutrophil count decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}], 'seriousEvents': [{'term': 'Vestibular Schwannoma', 'notes': 'Grade 2, unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Pneumonia', 'notes': 'Grade 4, expected and unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Fever', 'notes': 'Grade 2, expected and unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Headache', 'notes': 'grade 3, expected and unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Photophobia', 'notes': 'Grade 2, unexpected and unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficacy: Complete Response Rate (CRR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ofatumumab', 'description': 'single-arm, open-label, interventional\n\nofatumumab: Weekly infusion for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1-month post-treatment', 'description': 'Evaluate clinical efficacy of ofatumumab in previously untreated indolent B-cell lymphomas, as measured by complete response rate (CRR).\n\nComplete response = all previously enlarged fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET)-positive lymph nodes regressed to normal size (\\<=1.5 cm in greatest diameter)', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ofatumumab', 'description': 'single-arm, open-label, interventional\n\nofatumumab: Weekly infusion for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1-month post-treatment', 'description': 'Evaluate clinical efficacy of ofatumumab in previously untreated indolent B-cell lymphomas, as measured by overall response rate (ORR).\n\nOverall response = Complete response (CR) + Partial response (PR) CR = all previously enlarged fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET)-positive lymph nodes regressed to normal size (\\<=1.5cm in greatest diameter) PR = \\>=50% decrease in SPD of up to six largest dominant masses, no increase in size of other nodes; FDG avid or PET positive before therapy, one or more nodes PET positive at previously involved site, or variably FDG avid or PET negative with regression at CT', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ofatumumab', 'description': 'single-arm, open-label, interventional\n\nofatumumab: Weekly infusion for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000', 'lowerLimit': '72', 'upperLimit': '99'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Percentage of patients with progression-free survival during 12 months post-treatment progression-free survival: patients live with the disease, but it does not get worse', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Toxicity: Infusion Reactions, Grade 3-4 Infections, and Neutropenia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ofatumumab', 'description': 'single-arm, open-label, interventional\n\nofatumumab: Weekly infusion for 8 weeks'}], 'classes': [{'title': 'Infusion reactions (grade 1-2)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Infusion reactions (grade 3)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Infections (grade 3-4)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Neutropenia (grade 3-4)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Evaluate safety of ofatumumab monotherapy in this patient population Toxicities are graded 1 (mild), 2 (moderate), 3 (severe), and 4 (life-threatening)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ofatumumab', 'description': 'single-arm, open-label, interventional\n\nofatumumab: Weekly infusion for 8 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'The number enrolled (43) and number starting study (42) do not match because one patient never began study treatment due to an acute stroke prior to any study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ofatumumab', 'description': 'single-arm, open-label, interventional\n\nofatumumab: Weekly infusion for 8 weeks'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.4', 'groupId': 'BG000', 'lowerLimit': '33.7', 'upperLimit': '91.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Lymphoma type', 'classes': [{'categories': [{'title': 'Follicular', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Marginal zone', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Small lymphocytic', 'measurements': [{'value': '10', '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': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-18', 'studyFirstSubmitDate': '2010-11-10', 'resultsFirstSubmitDate': '2017-01-25', 'studyFirstSubmitQcDate': '2010-11-10', 'lastUpdatePostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-26', 'studyFirstPostDateStruct': {'date': '2010-11-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy: Complete Response Rate (CRR)', 'timeFrame': '1-month post-treatment', 'description': 'Evaluate clinical efficacy of ofatumumab in previously untreated indolent B-cell lymphomas, as measured by complete response rate (CRR).\n\nComplete response = all previously enlarged fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET)-positive lymph nodes regressed to normal size (\\<=1.5 cm in greatest diameter)'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': '1-month post-treatment', 'description': 'Evaluate clinical efficacy of ofatumumab in previously untreated indolent B-cell lymphomas, as measured by overall response rate (ORR).\n\nOverall response = Complete response (CR) + Partial response (PR) CR = all previously enlarged fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET)-positive lymph nodes regressed to normal size (\\<=1.5cm in greatest diameter) PR = \\>=50% decrease in SPD of up to six largest dominant masses, no increase in size of other nodes; FDG avid or PET positive before therapy, one or more nodes PET positive at previously involved site, or variably FDG avid or PET negative with regression at CT'}, {'measure': 'Progression-free Survival (PFS)', 'timeFrame': '12 months', 'description': 'Percentage of patients with progression-free survival during 12 months post-treatment progression-free survival: patients live with the disease, but it does not get worse'}, {'measure': 'Toxicity: Infusion Reactions, Grade 3-4 Infections, and Neutropenia', 'timeFrame': '2 years', 'description': 'Evaluate safety of ofatumumab monotherapy in this patient population Toxicities are graded 1 (mild), 2 (moderate), 3 (severe), and 4 (life-threatening)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['NHL', 'ofatumumab'], 'conditions': ['Follicular Lymphoma', 'Marginal Zone Lymphoma', 'Small Lymphocytic Lymphoma']}, 'descriptionModule': {'briefSummary': "Ofatumumab is a drug that works by attaching to the CD20 molecule found on the surface of cancerous B cells, and then triggering the death of those cells. It is approved by the FDA for treatment of another B-cell cancer, chronic lymphocytic leukemia, and also has evidence of success in people who's B-cell lymphomas have relapsed after initial treatments. In this research study we are looking to see if ofatumumab is effective and safe in treating previously untreated B-cell NHL.", 'detailedDescription': '* Participants will receive ofatumumab once a week for 8 weeks by intravenous infusion (Days 1, 8, 15, 22, 29, 36, 43, and 50).\n* Participants will be seen weekly during the 8 week treatment period and will have the following tests and procedures performed: Blood tests, performance status and physical examination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed indolent CD20+B-cell NHL of the following histologies: follicular lymphoma, grades 1-2; Marginal zone lymphoma (extranodal, nodal or splenic); small lymphocytic lymphoma; low-grade 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 as 20mm or greater CT scan or MRI\n* No previous chemotherapy, antibody therapy or radioimmunotherapy for this disease. Patients previously treated with external beam radiation alone are eligible\n* 18 years of age or older\n* Life expectancy of greater than 3 months\n* ECOG Performance status of 0, 1 or 2\n* Organ function as described in the protocol\n* Women of child-bearing potential and men must agree so use adequate contraception prior to study entry and for the duration of study participation\n\nExclusion Criteria:\n\n* Prior chemotherapy, antibody therapy or radioimmunotherapy for lymphoma\n* Participants may not be receiving any other investigational agent\n* Participants with known brain metastases\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ofatumumab\n* Prior exposure to ofatumumab or other targeted anti-CD20 therapies including rituximab\n* Known HIV positivity\n* Positive serology for Hepatitis B\n* Positive serology for Hepatitis C\n* Participants who are candidates for curative radiotherapy, unless radiation therapy is considered too toxic (as in abdominal disease), or is refused by the patient\n* New York Heart Association Classification III of IV heart 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 or breastfeeding women\n* History of a different malignancy are ineligible except for the following circumstances: Individuals with a history of other malignancy are eligible if they have been disease-free for at least one year and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible even if diagnosed and treated within the past 1 year: localized prostate cancer, prostate cancer with elevated PSA but no measurable disease on CT scans or bone scan, cervical cancer in situ, breast ductal carcinoma in situ and non-melanoma skin cancers.'}, 'identificationModule': {'nctId': 'NCT01239394', 'briefTitle': 'Ofatumumab for Initial Systemic Treatment of Indolent B-cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Phase II Trial Ofatumumab for Initial Systemic Treatment of Indolent B-cell Lymphoma', 'orgStudyIdInfo': {'id': '10-271'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ofatumumab', 'description': 'single-arm, open-label, interventional', 'interventionNames': ['Drug: ofatumumab']}], 'interventions': [{'name': 'ofatumumab', 'type': 'DRUG', 'otherNames': ['GSK1841157', 'HuMax-CD20'], 'description': 'Weekly infusion for 8 weeks', 'armGroupLabels': ['ofatumumab']}]}, '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': 'Beth Israel Deaconess Medical Center', '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 S. 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': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Lymphoma Program', 'investigatorFullName': 'Jeremy Abramson, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}