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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cell Therapeutics
ClinicalTrials.gov Identifier:
NCT00088530
First received: July 28, 2004
Last updated: May 20, 2013
Last verified: May 2013

July 28, 2004
May 20, 2013
July 2004
February 2010   (final data collection date for primary outcome measure)
Response [ Time Frame: 84 days ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00088530 on ClinicalTrials.gov Archive Site
toxicity [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Bulgaria,   Costa Rica,   Ecuador,   Estonia,   France,   Germany,   Hungary,   India,   Italy,   Mexico,   Panama,   Peru,   Poland,   Romania,   Russian Federation,   Ukraine,   United Kingdom,   Uruguay
 
NCT00088530
PIX301
Yes
Cell Therapeutics
Cell Therapeutics
Not Provided
Not Provided
Cell Therapeutics
May 2013

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