Ofatumumab for Initial Systemic Treatment of Indolent B-cell Lymphoma
NCT ID: NCT01239394
Last Updated: 2017-10-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2010-12-31
2015-03-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ofatumumab
single-arm, open-label, interventional
ofatumumab
Weekly infusion for 8 weeks
Interventions
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ofatumumab
Weekly infusion for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* No previous chemotherapy, antibody therapy or radioimmunotherapy for this disease. Patients previously treated with external beam radiation alone are eligible
* 18 years of age or older
* Life expectancy of greater than 3 months
* ECOG Performance status of 0, 1 or 2
* Organ function as described in the protocol
* Women of child-bearing potential and men must agree so use adequate contraception prior to study entry and for the duration of study participation
Exclusion Criteria
* Participants may not be receiving any other investigational agent
* Participants with known brain metastases
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ofatumumab
* Prior exposure to ofatumumab or other targeted anti-CD20 therapies including rituximab
* Known HIV positivity
* Positive serology for Hepatitis B
* Positive serology for Hepatitis C
* Participants who are candidates for curative radiotherapy, unless radiation therapy is considered too toxic (as in abdominal disease), or is refused by the patient
* New York Heart Association Classification III of IV heart disease
* 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
* Pregnant or breastfeeding women
* 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.
18 Years
ALL
No
Sponsors
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Dana-Farber Cancer Institute
OTHER
Beth Israel Deaconess Medical Center
OTHER
GlaxoSmithKline
INDUSTRY
Massachusetts General Hospital
OTHER
Responsible Party
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Jeremy Abramson, MD
Director, Lymphoma Program
Principal Investigators
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Jeremy S. Abramson, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Other Identifiers
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10-271
Identifier Type: -
Identifier Source: org_study_id