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Complete title: Head to Head Trial of Ofatumumab versus Rituximab A Phase III Randomized, Open Label Study of Single Agent Ofatumumab Vs. Single Agent Rituximab in Follicular Lymphoma Relapsed After Rituximab-Containing Therapy
|Research Study Number||2522.00|
|Principal Investigator||David Maloney, MD, PhD|
Research Study Description
This is a multi-center, parallel, active comparator controlled, open-label, randomized (1:1) phase III study of single agent ofatumumab compared to single agent rituximab in subjects with rituximab-sensitive grade 1, 2, and 3A follicular lymphoma that has relapsed at least 6 months after completing treatment with single agent rituximab or a rituximab-containing regimen. Subjects must have attained a Complete Response or Partial Response to their last prior rituximab containing therapy lasting at least six months beyond the end of rituximab therapy. Subjects will receive four weekly doses of single agent ofatumumab (1000 mg) or rituximab (375 mg/m2), followed by ofatumumab (1000 mg) or rituximab (375 mg/m2) every 2 months for four additional doses. Therefore, subjects will receive a total of eight doses of anti-CD20 antibody over 9 months. Subjects will be evaluated for response after completion of the first four doses of therapy, after six doses of therapy, and after completion of study therapy. Subjects will be followed until the end of the designated follow-up period (total study duration of 200 weeks) or until they meet the withdrawal criteria.
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- Follicular lymphoma (FL); grades 1, 2 and 3A, defined according to World Health Organization guidelines.
- Rituximab-sensitive FL, defined as a partial or complete response to treatment with rituximab or a rituximab-containing regimen lasting at least 6 months following completion of the last rituximab treatment.
- Relapse or disease progression following response to prior rituximab-based therapy, as defined by 2007 Revised Response Criteria for Malignant Lymphoma criteria, which requires therapy.
- Radiographically measurable disease, defined as at least one clearly demarcated lesion with a largest diameter = 2.0 cm by CT scan imaging.
- ECOG Performance Status of 0, 1, or 2.
- Age = 18 years.
- Life expectancy of at least 6 months in the opinion of the investigator.
- The patient or their legally acceptable representative must be capable of giving written informed consent prior to performing any study-specific tests or procedures.
- All prior treatment related non-hematologic toxicities (with the exception of alopecia) must have resolved to CTCAE (Version 4.0) = Grade 2 at the time of randomization.
- French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Previous radioimmunotherapy (RIT) within 6 months of randomization. Patients who have received previous RIT must have attained a partial or complete response lasting at least 6 months, and must have recovered from any hematologic or other toxicity.
- Previous autologous stem cell transplantation within 6 months of randomization.
- Previous allogeneic stem cell transplantation.
- Previous anti-lymphoma monoclonal antibody therapy (excluding rituximab), chemotherapy, glucocorticoid, or other systemic therapy for lymphoma within 3 months of randomization.
- Current or previous participation in another interventional clinical study within 4 weeks of randomization.
- Current or previous other malignancy within 2 years of randomization. Subjects who have been free of malignancy for at least 2 years, or have a history of completely resected non-melanoma skin cancer or successfully treated carcinoma in situ, are eligible.
- Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis, active Hepatitis C, and known HIV disease.
- Clinically significant cardiac disease as judged by the investigator including unstable angina, acute myocardial infarction within 6 months of randomization, congestive heart failure, and arrhythmia requiring therapy.
- Other significant concurrent, uncontrolled medical conditions including, but not limited to, renal, hepatic, autoimmune, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which, in the investigator's opinion, will impact study participation.
- Screening laboratory values:
Neutrophils < 1.5 x 109/L (unless due to FL involvement of the bone marrow).
Platelets < 50 x 109/L (unless due to FL involvement of the bone marrow).
ALT or AST > 2xULN, alkaline phosphatase and bilirubin > 1.5xULN (isolated predominantly indirect hyperbilirubinemia due to Gilbert's syndrome is acceptable for inclusion)
Known or suspected inability to fully comply with study protocol
a. Lactating women. b. Women with a positive pregnancy test at study entry c. Men with partners of childbearing potential and women of childbearing potential who are not willing to use adequate contraception from study entry through one year following last treatment dose.
14. Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones).
15. Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.
Other exclusion criteria may apply.
Hematologic Malignancies; Lymphoma
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