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Fludarabine, Pixantrone and Rituximab vs Fludarabine and Rituximab forRelapsed or Refractory Indolent NHL

Information source: CTI BioPharma
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-Hodgkin's Lymphoma

Intervention: fludarabine and rituximab (Drug); fludarabine, rituximab, pixantrone (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: CTI BioPharma

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.

Clinical Details

Official title: Fludarabine, BBR 2778 (Pixantrone) and Rituximab (FP-R) vs Fludarabine and Rituximab (F-R) for Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: progression-free survival

Secondary outcome: response rate, survival, safety

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria 1. Histologically confirmed relapsed or refractory indolent non-Hodgkin's lymphoma (NHL) 2. Any stage (Ann Arbor staging, Appendix 15. 7), with or without B symptoms 3. CD 20+ lymphoma (confirmed by immunochemistry) 4. Measurable disease. 5. Atleast 1 prior therapy. 6. Age ≥ 18 years 7. Life expectancy of at least 3 months 8. ECOG performance status (PS) of 0 or 1 9. Adequate cardiac function defined as LVEF ≥ 50% by MUGA scan 10. Adequate renal function 11. Adequate hepatic function 12. Adequate bone marrow function 13. Recovery from all acute toxicities from prior therapies (except alopecia and grade 1 peripheral neuropathy). Exclusion Criteria 1. Prior treatment with a cumulative dose of doxorubicin equivalent exceeding 450 mg/m2 2. Radiotherapy, chemotherapy or other therapies for NHL within 4 weeks of treatment start 3. Systemic corticosteroids to treat NHL within 5 days prior to first dose of study treatment. 4. Radioimmunotherapy (RIT) within 3 months of treatment start 5. Known hypersensitivity to the excipients or the study drugs that the patient will receive 6. Known Type I hypersensitivity or anaphylactic reactions to murine proteins or to any component of rituximab 7. 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) 8. HIV-related lymphoma 9. Active CNS involvement 10. Clinically significant cardiovascular abnormalities 11. Serious (NCI CTCAE grade 3-4) intercurrent infection at randomization, infection requiring oral antibiotics, or deep-seated or systemic mycotic infections. 12. Investigational study drug within 30 days before randomization. Patient must have recovered from all side effects of other investigational therapy. 13. Clinical symptoms suggesting unresolved HIV, HBV or HCV infection. . 14. 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 15. Pregnant or lactating women 16. 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

Locations and Contacts

Northwest Alabama Cancer Center, Muscle Shoals, Alabama 35661, United States

Ventura County Hematology Oncology Specialist, Oxnard, California 93030, United States

Capitol Comprehensive Cancer Care, Jefferson City, Missouri 65109, United States

Heartland Hematology Oncology Associates, Kansas City, Missouri 64118, United States

Cancer Care Center, New Albany, New York 47150, United States

Interlakes Foundation, Inc., Rochester, New York 14623, United States

Hematology Oncology Consultants, Columbus, Ohio 43235, United States

Utah Hematology Oncology, P.C., Ogden, Utah 84403, United States

Additional Information

Starting date: September 2007
Last updated: September 19, 2008

Page last updated: August 20, 2015

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