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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00577161

Recruitment Status : Withdrawn (closed to enrollment)

First Posted : December 19, 2007

Last Update Posted : October 5, 2020

Sponsor:

Information provided by (Responsible Party):

CTI BioPharma

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Non-Hodgkin's Lymphoma	Drug: fludarabine and rituximab Drug: fludarabine, rituximab, pixantrone	Phase 3

Study Design

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Drug Information available for: Fludarabine Fludarabine phosphate Rituximab

Genetic and Rare Diseases Information Center resources: Lymphosarcoma

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

progression-free survival [ Time Frame: day 64-71 ]

Secondary Outcome Measures :

response rate, survival, safety [ Time Frame: every 21 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Locations

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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

Sponsors and Collaborators

CTI BioPharma

More Information

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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

Keywords provided by CTI BioPharma:


pixantrone NHL rituximab fludarabine

Additional relevant MeSH terms:

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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

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