Study Stopped
closed to enrollment
Fludarabine, Pixantrone and Rituximab vs Fludarabine and Rituximab forRelapsed or Refractory Indolent NHL
Fludarabine, BBR 2778 (Pixantrone) and Rituximab (FP-R) vs Fludarabine and Rituximab (F-R) for Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
1 other identifier
interventional
N/A
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2007
Longer than P75 for phase_3
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 17, 2007
CompletedFirst Posted
Study publicly available on registry
December 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedOctober 5, 2020
October 1, 2020
4.8 years
December 17, 2007
October 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
progression-free survival
day 64-71
Secondary Outcomes (1)
response rate, survival, safety
every 21 days
Study Arms (2)
Comparator
ACTIVE COMPARATORfludarabine and rituximab
Experimental
EXPERIMENTALfludarabine, rituximab, pixantrone
Interventions
days 1 to 4 of six 28-day cycles rituximab 375 mg/m2 fludarabine 25 mg/m2
days 1 to 4 of six 28-day cycles rituximab 375 mg/m2 fludarabine 25 mg/m2 pixantrone 120 mg/m2 day 2 only
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CTI BioPharmalead
Study Sites (8)
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
Albany, New York, 12208, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2007
First Posted
December 19, 2007
Study Start
September 1, 2007
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
October 5, 2020
Record last verified: 2020-10