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

This study has been terminated.
(closed to enrollment)
Sponsor:
Information provided by:
CTI BioPharma
ClinicalTrials.gov Identifier:
NCT00577161
First received: December 17, 2007
Last updated: September 19, 2008
Last verified: September 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by CTI BioPharma:

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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cancer Care Center
New Albany, New York, United States, 47150
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

No publications provided

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

Keywords provided by CTI BioPharma:
pixantrone
NHL
rituximab
fludarabine

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Fludarabine
Fludarabine monophosphate
Pixantrone
Rituximab
Vidarabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 26, 2014