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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00060671
First Posted: May 12, 2003
Last Update Posted: January 19, 2015
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
  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
Intervention Model: Parallel Assignment
Masking: None (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:

Primary Outcome Measures:
  • Compare the time to tumor progression (TTP) of the combination of BBR 2778 (pixantrone) + rituximab with that of rituximab alone [ Time Frame: For 5 years post treatment ]

Secondary Outcome Measures:
  • To compare BBR 2778 + rituximab versus rituximab for: [ Time Frame: For 5 years post treatment ]
    • objective overall response rate (ORR; CR + PR)
    • objective complete response rate (CRR)
    • rate of molecular remission
    • time to response
    • time to complete response
    • duration of response
    • Time to Tumor Progression requiring treatment
    • Quality-Adjusted Time To Progression (QATTP)
    • overall survival
    • disease-specific survival
    • safety/tolerability


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00060671


  Show 38 Study Locations
Sponsors and Collaborators
CTI BioPharma
  More Information

Publications:
Santoro A; Voglova J; Gabrail N; Ciuleanu T; Liberati M; Hancock BW; Stromatt S; Caballero D; Comparative Trial of Pixantrone + Rituximab vs Single agent Rituximab in the Treatment of Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma; American Society of Clinical Oncology abstract and poster; Part 1, Vol 24 No 18S, June 20 supplement, 2006: 7578

Responsible Party: CTI BioPharma
ClinicalTrials.gov Identifier: NCT00060671     History of Changes
Obsolete Identifiers: NCT00062361
Other Study ID Numbers: AZA III 02
First Submitted: May 9, 2003
First Posted: May 12, 2003
Last Update Posted: January 19, 2015
Last Verified: May 2013

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, Non-Hodgkin
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pixantrone
Rituximab
Antibodies
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action