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Fludarabine, Pixantrone and Rituximab vs Fludarabine and Rituximab forRelapsed or Refractory Indolent NHL
This study has been terminated.
Sponsored by: Cell Therapeutics
Information provided by: Cell Therapeutics
ClinicalTrials.gov Identifier: NCT00577161
  Purpose

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 Intervention Phase
Non-Hodgkin's Lymphoma
Drug: fludarabine and rituximab
Drug: fludarabine, rituximab, pixantrone
Phase III

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Fludarabine Fludarabine monophosphate Rituximab 6,9-Bis((2-aminoethyl)amino)benzo(g)isoquinoline-5,10-dione
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Cell Therapeutics:

Primary Outcome Measures:
  • progression-free survival [ Time Frame: day 64-71 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • response rate, survival, safety [ Time Frame: every 21 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: September 2007
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Comparator: Active 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  11. Adequate hepatic function
  12. Adequate bone marrow function
  13. Recovery from all acute toxicities from prior therapies (except alopecia and grade 1 peripheral neuropathy).

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
  11. Serious (NCI CTCAE grade 3-4) intercurrent infection at randomization, infection requiring oral antibiotics, or deep-seated or systemic mycotic infections.
  12. Investigational study drug within 30 days before randomization. Patient must have recovered from all side effects of other investigational therapy.
  13. Clinical symptoms suggesting unresolved HIV, HBV or HCV infection. .
  14. 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
  15. Pregnant or lactating women
  16. 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00577161

Locations
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
Interlakes Foundation, Inc.
Rochester, New York, United States, 14623
Cancer Care Center
New Albany, New York, United States, 47150
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
Cell Therapeutics
  More Information

Responsible Party: Cell Therapeutics, Inc ( Igor Gorbatchevsky, Medical Director )
Study ID Numbers: PIX303
Study First Received: December 17, 2007
Last Updated: September 19, 2008
ClinicalTrials.gov Identifier: NCT00577161  
Health Authority: United States: Food and Drug Administration

Keywords provided by Cell Therapeutics:
pixantrone
NHL
rituximab
fludarabine

Study placed in the following topic categories:
Lymphatic Diseases
Immunoproliferative Disorders
Rituximab
Lymphoma, small cleaved-cell, diffuse
Fludarabine
Fludarabine monophosphate
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:
Antimetabolites
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Antirheumatic Agents

ClinicalTrials.gov processed this record on January 16, 2009