Comparative Trial for Pixantrone in Combination With Rituximab in Indolent Non-Hodgkin's Lymphoma

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
CTI BioPharma
ClinicalTrials.gov Identifier:
NCT00060671
First received: May 9, 2003
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to determine whether combining pixantrone (BBR 2778, INN name pending) with the monoclonal antibody rituximab, leads to an increase in the period of patients' remission, compared to rituximab alone.


Condition Intervention Phase
Lymphoma, Follicular
Lymphoma, Mixed-Cell, Follicular
Lymphoma, Small Cleaved-Cell, Follicular
Lymphoma, Low-Grade
Drug: rituximab
Drug: Pixantrone (BBR 2778)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, Phase III Comparative Trial of BBR 2778 + Rituximab Versus Rituximab in the Treatment of Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma (NHL)

Resource links provided by NLM:


Further study details as provided by CTI BioPharma:

Estimated Enrollment: 800
Study Start Date: January 2005
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Detailed Description:

This trial is being conducted in patients with indolent (or low-grade) non-Hodgkin's lymphoma, who have either relapsed or been refractory to previous treatment.

Pixantrone belongs to the DNA intercalator family of chemotherapy agents, which includes anthracyclines. DNA intercalators are commonly used to treat patients with indolent NHL, often in combination with the monoclonal antibody rituximab. This study represents the first large-scale, comparative trial in indolent NHL, designed to determine whether the response rate and time to tumour progression in patients treated with a combination of rituximab and a DNA intercalator, is significantly higher than seen in patients treated with rituximab alone.

This trial is randomized and controlled, which means that participating patients will be randomly assigned to one of two treatment groups:

  1. Patients treated with both pixantrone and rituximab, in combination
  2. Patients treated with only rituximab

This trial is expected to recruit around 800 patients in the US, Europe and Israel, with 400 patients recruited to each group.

Patients will be treated for around 18 weeks and will recieve regular physician monitoring for five years from the end of treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients with relapsed or refractory indolent non-Hodgkin's lymphoma (NHL), including follicular lymphoma grade I and II
  • Presenting with an episode of progressive disease, following 1-5 prior treatments (with either radiation, chemotherapy or rituximab).

Exclusion criteria:

  • Patients that failed to respond to previous rituximab treatment, or relapsed within 6 months of the first rituximab infusion
  • Patients known to have an allergic reaction to rituximab or murine derived proteins.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060671

  Show 38 Study Locations
Sponsors and Collaborators
CTI BioPharma
  More Information

No publications provided

Responsible Party: CTI BioPharma
ClinicalTrials.gov Identifier: NCT00060671     History of Changes
Obsolete Identifiers: NCT00062361
Other Study ID Numbers: AZA III 02
Study First Received: May 9, 2003
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by CTI BioPharma:
Pixantrone
BBR 2778
chemotherapy
DNA Intercalator
Anthracycline
Rituximab
Rituxan
Mabthera
monoclonal antibody
antibody
NHL
Non-Hodgkin's lymphoma
indolent
low grade
Novuspharma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pixantrone
Rituximab
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 20, 2014