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BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00088530
First Posted: July 29, 2004
Last Update Posted: June 1, 2017
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.
Information provided by (Responsible Party):
CTI BioPharma
July 28, 2004
July 29, 2004
March 11, 2017
June 1, 2017
June 1, 2017
July 2004
February 2010   (Final data collection date for primary outcome measure)
Complete Response (CR) and Complete Response Unconfirmed (CRu) [ Time Frame: EOT; approximately 6 months ]
Proportion of patients with a best response of complete response (CR) or Complete Response unconfirmed (CRu) in the End Of Treatment (EOT) or End Of Study (EOS) analyses by independent assessment in the Intent-to-treat (ITT) population through the End of Treatment (EOT)
Not Provided
Complete list of historical versions of study NCT00088530 on ClinicalTrials.gov Archive Site
  • Progression-Free Survival (PFS) [ Time Frame: 18 months after 6 cycles of treatment; approximately 24 months ]
    The time between the date of randomization and the date of the initial documentation of progressive/relapsed disease or death due to any cause.
  • Overall Survival [ Time Frame: 18 months after 6 cycles of treatment; approximately 24 months ]
    The time between the date of randomization and the date of death due to any cause.
  • Overall Response Rate (ORR) Lasting at Least 4 Months [ Time Frame: approximately 24 months ]
    The proportion of patients with Complete response or Partial Response with a difference from the first documented objective response to disease progression or death of at least 4 months.
Not Provided
Not Provided
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BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)
Pixantrone (BBR 2778) Versus Other Chemotherapeutic Agents for Third-line Single Agent Treatment of Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma: A Randomized, Controlled, Phase III Comparative Trial

BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and shows reduced potential for cardiotoxicity in animal models. This cytotoxic agent has structural similarities with mitoxantrone as well as general similarities with anthracyclines (such as the tricyclic central quinoid chromophore).

The primary study objective is to compare the efficacy of BBR 2778 to a selection of single agents. Secondary objectives are to compare the safety and tolerability of BBR 2778 to a selection of single agents, and to assess the pharmacokinetic parameters of BBR 2778 in a subset of this patient population.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lymphoma, Non-Hodgkin
  • Drug: pixantrone, cyclophosphamide, vincristine, rituximab, prednisone
    Day 1: pixantrone (150 mg/m2), cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day)
    Other Name: BBR2778
  • Drug: Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab
    Day 1: cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day)
  • Experimental: 1
    Intervention: Drug: pixantrone, cyclophosphamide, vincristine, rituximab, prednisone
  • Active Comparator: 2
    Intervention: Drug: Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab
Pettengell R, Coiffier B, Narayanan G, de Mendoza FH, Digumarti R, Gomez H, Zinzani PL, Schiller G, Rizzieri D, Boland G, Cernohous P, Wang L, Kuepfer C, Gorbatchevsky I, Singer JW. Pixantrone dimaleate versus other chemotherapeutic agents as a single-agent salvage treatment in patients with relapsed or refractory aggressive non-Hodgkin lymphoma: a phase 3, multicentre, open-label, randomised trial. Lancet Oncol. 2012 Jul;13(7):696-706. doi: 10.1016/S1470-2045(12)70212-7. Epub 2012 May 30. Erratum in: Lancet Oncol. 2012 Jul;13(7):e285.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
July 2010
February 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed aggressive [de novo or transformed] NHL according to REAL/WHO classification.
  • At least one objectively measurable lesion as demonstrated by CT, spiral CT, or MRI and plain radiograph of the chest (chest x-ray, for chest lesions only) that can be followed for response as target lesion.
  • Relapse after 2 or more prior regimens of chemotherapy
  • ECOG performance status of 0, 1, or 2
  • Adequate hematologic, renal and hepatic function
  • LVEF ≥50% determined by MUGA scan

Exclusion Criteria:

  • Prior treatment with a cumulative dose of doxorubicin or equivalent exceeding 450 mg/m²
  • Prior allogenic stem cell transplant
  • Histological diagnosis of Burkitt lymphoma, lymphoblastic lymphoma or Mantle cell lymphoma
  • Active CNS lymphoma or HIV-related lymphoma.
  • Any chemotherapy, radiotherapy, or other anticancer treatment (including corticosteroid, 10 or more mg/day of prednisone or equivalent) within the 2 weeks before randomization
  • Pregnant women or nursing mothers
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Bulgaria,   Costa Rica,   Ecuador,   Estonia,   France,   Germany,   Hungary,   India,   Italy,   Mexico,   Panama,   Peru,   Poland,   Romania,   Russian Federation,   Ukraine,   United Kingdom,   United States,   Uruguay
 
 
NCT00088530
PIX301
Yes
Not Provided
Not Provided
CTI BioPharma
CTI BioPharma
Not Provided
Not Provided
CTI BioPharma
April 2017

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