Fludarabine, Pixantrone and Rituximab vs Fludarabine and Rituximab forRelapsed or Refractory Indolent NHL
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ClinicalTrials.gov Identifier: NCT00577161 |
Recruitment Status :
Withdrawn
(closed to enrollment)
First Posted : December 19, 2007
Last Update Posted : October 5, 2020
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-Hodgkin's Lymphoma | Drug: fludarabine and rituximab Drug: fludarabine, rituximab, pixantrone | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | September 2007 |
Actual Primary Completion Date : | July 2012 |
Actual Study Completion Date : | July 2012 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Comparator
fludarabine and rituximab
|
Drug: fludarabine and rituximab
days 1 to 4 of six 28-day cycles rituximab 375 mg/m2 fludarabine 25 mg/m2 |
Experimental: Experimental
fludarabine, rituximab, pixantrone
|
Drug: fludarabine, rituximab, pixantrone
days 1 to 4 of six 28-day cycles rituximab 375 mg/m2 fludarabine 25 mg/m2 pixantrone 120 mg/m2 day 2 only |
- progression-free survival [ Time Frame: day 64-71 ]
- response rate, survival, safety [ Time Frame: every 21 days ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00577161
United States, Alabama | |
Northwest Alabama Cancer Center | |
Muscle Shoals, Alabama, United States, 35661 | |
United States, California | |
Ventura County Hematology Oncology Specialist | |
Oxnard, California, United States, 93030 | |
United States, Missouri | |
Capitol Comprehensive Cancer Care | |
Jefferson City, Missouri, United States, 65109 | |
Heartland Hematology Oncology Associates | |
Kansas City, Missouri, United States, 64118 | |
United States, New York | |
Cancer Care Center | |
Albany, New York, United States, 12208 | |
Interlakes Foundation, Inc. | |
Rochester, New York, United States, 14623 | |
United States, Ohio | |
Hematology Oncology Consultants | |
Columbus, Ohio, United States, 43235 | |
United States, Utah | |
Utah Hematology Oncology, P.C. | |
Ogden, Utah, United States, 84403 |
Responsible Party: | CTI BioPharma |
ClinicalTrials.gov Identifier: | NCT00577161 |
Other Study ID Numbers: |
PIX303 |
First Posted: | December 19, 2007 Key Record Dates |
Last Update Posted: | October 5, 2020 |
Last Verified: | October 2020 |
pixantrone NHL rituximab fludarabine |
Lymphoma Lymphoma, Non-Hodgkin Pixantrone Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Vidarabine Rituximab Fludarabine Fludarabine phosphate Antineoplastic Agents, Immunological |
Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Antiviral Agents Anti-Infective Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |