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

January 15, 2015 updated by: CTI BioPharma

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Arizona Clinical Research Center
    • California
      • Greenbrae, California, United States, 94904
        • Sutter Health Western Division Cancer Research Group
      • Los Angeles, California, United States, 90057
        • Kenmar Research Institute
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Moutain Cancer Center
    • Florida
      • New Port Richey, Florida, United States
        • Pasco, Hernando Oncology Associates, P.A.
      • Ocala, Florida, United States, 34474
        • Ocala Oncology Center
      • Orange Park, Florida, United States, 32073
        • Orange Park Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center Hematology / Oncology
      • Chicago, Illinois, United States, 60657
        • Illinois Masonic Cancer Center
      • Naperville, Illinois, United States, 60540
        • Edward Cancer Center
    • Indiana
      • Terre Haute, Indiana, United States, 47802
        • Hope Center
    • Kentucky
      • Danville, Kentucky, United States, 40422
        • Commonwealth Hematology/Oncology
    • Massachusetts
      • Wellesley, Massachusetts, United States, 02481
        • New England Hematology / Oncology Associates
    • Missouri
      • St Joseph, Missouri, United States, 64507
        • St. Joseph Oncology
      • St Louis, Missouri, United States, 63136
        • Christian Hospital
      • St. Louis, Missouri, United States, 63141
        • St. Johns Mercy Medical Center
    • Montana
      • Billings, Montana, United States, 59101
        • Hematology - Oncology Centers of N. Rockies
      • Great Falls, Montana, United States, 59405
        • Great Falls Clinic
    • New Jersey
      • East Orange, New Jersey, United States, 07018
        • East Orange VA Medical Center
      • Paramus, New Jersey, United States, 07652
        • Hematology Oncology Associates of NJ
      • Summit, New Jersey, United States, 07901
        • Summit Medical Group/Overlook Onc Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • New Mexico Oncology / Hematology
    • New York
      • Brooklyn, New York, United States, 11235
        • HemOnCare, P.C.
      • Glens Falls, New York, United States, 12801
        • Glens Falls Cancer Center
      • New Hyde Park, New York, United States, 11040
        • North Shore - Long Island Jewish Health System
      • New York, New York, United States, 10016
        • New York University
      • Rochester, New York, United States, 14623
        • Upstate NY Cancer Research
      • Rockville Centre, New York, United States, 11570
        • South Shore Hematology-Oncology Associates
    • North Carolina
      • Charlotte, North Carolina, United States
        • Clinworks, Inc
    • Ohio
      • Canton, Ohio, United States, 44718
        • Private Practice
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16601
        • Blair Medical Associates
      • Lancaster, Pennsylvania, United States, 17605
        • Lancaster Cancer Center, Ltd
    • South Carolina
      • Sumter, South Carolina, United States, 29150
        • Santee Hematology Oncology
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • The West Clinic
    • Utah
      • Provo, Utah, United States, 84604
        • Central Utah Medical Clinic Hematology-Oncology
    • Wisconsin
      • Glendale, Wisconsin, United States, 53212
        • Oncology of Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic
      • Rhinelander, Wisconsin, United States, 54501
        • Rhinelander Regional Medical Group Onc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
For 5 years post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
For 5 years post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CTI BioPharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

May 9, 2003

First Submitted That Met QC Criteria

May 9, 2003

First Posted (Estimate)

May 12, 2003

Study Record Updates

Last Update Posted (Estimate)

January 19, 2015

Last Update Submitted That Met QC Criteria

January 15, 2015

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZA III 02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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