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

Withdrawn before enrolling · Phase 3

Conditions studied: Non-Hodgkin's Lymphoma

In brief

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.

Key facts

Study ID

NCT00577161

Run by

CTI BioPharma

People needed

0

Starts

2007-09-01

Expected to finish

2012-07-01

Last updated by the study team

2020-10-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• Northwest Alabama Cancer Center — Muscle Shoals, Alabama, United States
• Ventura County Hematology Oncology Specialist — Oxnard, California, United States
• Capitol Comprehensive Cancer Care — Jefferson City, Missouri, United States
• Heartland Hematology Oncology Associates — Kansas City, Missouri, United States
• Cancer Care Center — Albany, New York, United States
• Interlakes Foundation, Inc. — Rochester, New York, United States
• Hematology Oncology Consultants — Columbus, Ohio, United States
• Utah Hematology Oncology, P.C. — Ogden, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.