CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 140 enrolled
Drug / intervention
pixantrone, cyclophosphamide, vincristine, rituximab, prednisone +1 moredrug
Likely dose
Pixantrone 150 mg/m² on Day 1 (as part of combination chemotherapy regimen)AI-extracted
Key inclusion· 6
  • ✓Histologically confirmed aggressive NHL (de novo or transformed) per REAL/WHO classification
  • ✓At least one objectively measurable lesion by CT, MRI, or plain radiograph to serve as target lesion
  • ✓Relapsed disease after ≥2 prior chemotherapy regimens
  • ✓ECOG performance status 0, 1, or 2
Key exclusion· 6
  • ✕Prior cumulative doxorubicin or equivalent dose >450 mg/m²
  • ✕Prior allogeneic stem cell transplantation
  • ✕Burkitt lymphoma, lymphoblastic lymphoma, or mantle cell lymphoma histology
  • ✕Active CNS lymphoma or HIV-related lymphoma

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00088530
NCT00088530Phase 3Completed
CompareCT.gov

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

CTI BioPharma·interventional·Posted Jul 29, 2004·Updated Feb 5, 2020

In Brief

A Phase 3 clinical trial evaluating pixantrone, cyclophosphamide, vincristine, rituximab, prednisone and Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab for Lymphoma, Non-Hodgkin. Completed, enrolled 140 participants across 99 sites in 20 countries.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, Non-Hodgkin
CountriesArgentina, Bulgaria, Costa Rica, Ecuador, Estonia, France, Germany, Hungary, India, Italy, Mexico, Panama, Peru, Poland, Romania, Russia, Ukraine, United Kingdom, United States, Uruguay
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 29, 2004
Enrollment StartJul 1, 2004
Primary CompletionFeb 1, 2010
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 21.9 years ago

Interventions

pixantrone, cyclophosphamide, vincristine, rituximab, prednisonedrug

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)

Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximabdrug

Day 1: cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day)