Non Hodgkin Lymphoma Clinical Trial
Fludarabine, Pixantrone and Rituximab vs Fludarabine and Rituximab forRelapsed or Refractory Indolent NHL
Summary
BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and reduced delayed cardiotoxicity in animal models compared to reference standards. This cytotoxic agent has structural similarities to mitoxantrone as well as general similarities to anthracyclines (such as the tricyclic central quinoid chromophore7).
This phase III study will compare the efficacy and safety of the combination BBR 2778, fludarabine, and rituximab with the combination fludarabine and rituximab in patients with relapsed or refractory indolent non-Hodgkin's lymphoma.
Eligibility Criteria
Inclusion Criteria
Histologically confirmed relapsed or refractory indolent non-Hodgkin's lymphoma (NHL)
Any stage (Ann Arbor staging, Appendix 15.7), with or without B symptoms
CD 20+ lymphoma (confirmed by immunochemistry)
Measurable disease.
Atleast 1 prior therapy.
Age ≥ 18 years
Life expectancy of at least 3 months
ECOG performance status (PS) of 0 or 1
Adequate cardiac function defined as LVEF ≥ 50% by MUGA scan
Adequate renal function
Adequate hepatic function
Adequate bone marrow function
Recovery from all acute toxicities from prior therapies (except alopecia and grade 1 peripheral neuropathy).
Exclusion Criteria
Prior treatment with a cumulative dose of doxorubicin equivalent exceeding 450 mg/m2
Radiotherapy, chemotherapy or other therapies for NHL within 4 weeks of treatment start
Systemic corticosteroids to treat NHL within 5 days prior to first dose of study treatment.
Radioimmunotherapy (RIT) within 3 months of treatment start
Known hypersensitivity to the excipients or the study drugs that the patient will receive
Known Type I hypersensitivity or anaphylactic reactions to murine proteins or to any component of rituximab
Major thoracic and/or abdominal surgery in the preceding 4 weeks, from which the patient has not fully recovered (patients who have had minor surgery and one week's recovery period may be enrolled)
HIV-related lymphoma
Active CNS involvement
Clinically significant cardiovascular abnormalities
Serious (NCI CTCAE grade 3-4) intercurrent infection at randomization, infection requiring oral antibiotics, or deep-seated or systemic mycotic infections.
Investigational study drug within 30 days before randomization. Patient must have recovered from all side effects of other investigational therapy.
Clinical symptoms suggesting unresolved HIV, HBV or HCV infection. .
History of another malignancy except: curatively treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in remission, or any other cancer from which the patient has been disease-free for 5 years
Pregnant or lactating women
Potentially fertile men and women and their sexual partners not willing to use adequate contraception as defined by the Investigator during the study and for 6 months after the last day of study drug administration
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There are 8 Locations for this study
Muscle Shoals Alabama, 35661, United States
Oxnard California, 93030, United States
Jefferson City Missouri, 65109, United States
Kansas City Missouri, 64118, United States
Albany New York, 12208, United States
Rochester New York, 14623, United States
Columbus Ohio, 43235, United States
Ogden Utah, 84403, United States
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