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SCCA Lymphoma Clinical Trials

Ofatumumab vs. Rituximab for Relapsed Follicular Lymphoma (FH 2522)
Phase III Randomized, Open Label Study of Single Agent Ofatumumab Vs. Single Agent Rituximab in Follicular Lymphoma Relapsed After Rituximab-Containing Therapy
Status Conditions Phase Study ID
Recruiting Follicular Lymphoma Phase III FH 2522
NCT01200589
Summary

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.


Investigator
David Maloney, MD, PhD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  1. Follicular lymphoma (FL); grades 1, 2 and 3A, defined according to World Health Organization guidelines.
  2. 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.
  3. 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.
  4. Radiographically measurable disease, defined as at least one clearly demarcated lesion with a largest diameter ≥ 2.0 cm by CT scan imaging.
  5. ECOG Performance Status of 0, 1, or 2.
  6. Age ≥ 18 years.
  7. Life expectancy of at least 6 months in the opinion of the investigator.
  8. The patient or their legally acceptable representative must be capable of giving written informed consent prior to performing any study-specific tests or procedures.
  9. 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
Exclusions (conditions that would prevent participation in this study)
  1. Previous treatment with ofatumumab.
  2. 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.
  3. Previous autologous stem cell transplantation within 6 months of randomization.
  4. Previous allogeneic stem cell transplantation.
  5. Previous anti-lymphoma monoclonal antibody therapy (excluding rituximab), chemotherapy, glucocorticoid, or other systemic therapy for lymphoma within 3 months of randomization.
  6. Current or previous participation in another interventional clinical study within 4 weeks of randomization.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. Screening laboratory values:
    1. Neutrophils < 1.5 x 109/L (unless due to FL involvement of the bone marrow).
    2. Platelets < 50 x 109/L (unless due to FL involvement of the bone marrow).
    3. ALT or AST > 2xULN, alkaline phosphatase and bilirubin > 1.5xULN (isolated predominantly indirect hyperbilirubinemia due to Gilbert's syndrome is acceptable for inclusion)
  12. Known or suspected inability to fully comply with study protocol.
Last Updated
November 07, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.