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

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ClinicalTrials.gov Identifier: NCT00060671
Recruitment Status : Terminated
First Posted : May 12, 2003
Last Update Posted : January 19, 2015
Sponsor:
Information provided by (Responsible Party):
CTI BioPharma

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Lymphoma, Follicular Lymphoma, Mixed-Cell, Follicular Lymphoma, Small Cleaved-Cell, Follicular Lymphoma, Low-Grade Drug: rituximab Drug: Pixantrone (BBR 2778) Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 800 participants
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)
Study Start Date : January 2005
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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


Locations
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Sponsors and Collaborators
CTI BioPharma
More Information
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Publications of Results:
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

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Responsible Party: CTI BioPharma
ClinicalTrials.gov Identifier: NCT00060671    
Obsolete Identifiers: NCT00062361
Other Study ID Numbers: AZA III 02
First Posted: May 12, 2003    Key Record Dates
Last Update Posted: January 19, 2015
Last Verified: May 2013
Keywords provided by CTI BioPharma:
Pixantrone
BBR 2778
Non-Hodgkin's lymphoma
chemotherapy
DNA Intercalator
Anthracycline
Rituximab
Rituxan
 Mabthera
monoclonal antibody
antibody
NHL
indolent
low grade
Novuspharma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Follicular
Pixantrone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action