BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)
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.
|Lymphoma, Non-Hodgkin||Drug: pixantrone, cyclophosphamide, vincristine, rituximab, prednisone Drug: Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||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|
- 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)
- 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.
|Study Start Date:||July 2004|
|Study Completion Date:||July 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
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
|Active Comparator: 2||
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00088530
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