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WITHDRAWNPHASE3

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

NCT00577161•CTI BioPharma

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+3 more criteria

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
+6 more criteria

Locations (8)

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

Key Dates

Start Date

September 1, 2007

Primary Completion Date

July 1, 2012

Completion Date

July 1, 2012

Last Updated

October 5, 2020

Conditions

Non-Hodgkin's Lymphoma

Interventions

fludarabine and rituximab

DRUG

fludarabine, rituximab, pixantrone

DRUG

Study to Evaluate Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-291 Moves Through the Body in Adult Participants With Non-Hodgkin's Lymphoma

NCT06667687

Non-Hodgkin's Lymphoma

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RECRUITINGPHASE1/PHASE2

A Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

NCT05623982

Non-hodgkin's Lymphoma

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RECRUITINGPHASE2

Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 5, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Study to Evaluate Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-291 Moves Through the Body in Adult Participants With Non-Hodgkin's Lymphoma

A Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

Phase II Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma

CART19 Cells Effects in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma

Palifermin With Leuprolide Acetate for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation