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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

December 17, 2007
September 19, 2008
September 2007
July 2012   (final data collection date for primary outcome measure)
progression-free survival [ Time Frame: day 64-71 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00577161 on ClinicalTrials.gov Archive Site
response rate, survival, safety [ Time Frame: every 21 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Non-Hodgkin's Lymphoma
  • Drug: fludarabine and rituximab
    days 1 to 4 of six 28-day cycles rituximab 375 mg/m2 fludarabine 25 mg/m2
  • 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
  • Active Comparator: Comparator
    fludarabine and rituximab
    Intervention: Drug: fludarabine and rituximab
  • Experimental: Experimental
    fludarabine, rituximab, pixantrone
    Intervention: Drug: fludarabine, rituximab, pixantrone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
300
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00577161
PIX303
Yes
Igor Gorbatchevsky, Medical Director, Cell Therapeutics, Inc
CTI BioPharma
Not Provided
Not Provided
CTI BioPharma
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP