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Lymphoma, FollicularPhase 3NCT00060671

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

A Phase 3 study testing rituximab and Pixantrone (BBR 2778) in people with Lymphoma, Follicular and Lymphoma, Mixed-Cell, Follicular, run by CTI BioPharma at 38 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
rituximab and Pixantrone (BBR 2778)
How many people
800 participants
Where
38 sitesUnited States
Study dates
Jan 2005to Jan 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

United States38 sites

  • New Mexico Oncology / Hematology

    Albuquerque, New Mexico, 87109

  • Blair Medical Associates

    Altoona, Pennsylvania, 16601

  • Hematology - Oncology Centers of N. Rockies

    Billings, Montana, 59101

  • HemOnCare, P.C.

    Brooklyn, New York, 11235

  • Private Practice

    Canton, Ohio, 44718

  • Clinworks, Inc

    Charlotte, North Carolina

  • University of Chicago Medical Center Hematology / Oncology

    Chicago, Illinois, 60637

  • Illinois Masonic Cancer Center

    Chicago, Illinois, 60657

  • Commonwealth Hematology/Oncology

    Danville, Kentucky, 40422

  • Rocky Moutain Cancer Center

    Denver, Colorado, 80218

  • East Orange VA Medical Center

    East Orange, New Jersey, 07018

  • Oncology of Wisconsin

    Glendale, Wisconsin, 53212

  • Glens Falls Cancer Center

    Glens Falls, New York, 12801

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Sutter Health Western Division Cancer Research Group

    Greenbrae, California, 94904

  • Lancaster Cancer Center, LTD

    Lancaster, Pennsylvania, 17605

  • Kenmar Research Institute

    Los Angeles, California, 90057

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • The West Clinic

    Memphis, Tennessee, 38120

  • Edward Cancer Center

    Naperville, Illinois, 60540

  • North Shore - Long Island Jewish Health System

    New Hyde Park, New York, 11040

  • Pasco, Hernando Oncology Associates, P.A.

    New Port Richey, Florida

  • New York University

    New York, New York, 10016

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • Orange Park Cancer Center

    Orange Park, Florida, 32073

  • Hematology Oncology Associates of NJ

    Paramus, New Jersey, 07652

  • Central Utah Medical Clinic Hematology-Oncology

    Provo, Utah, 84604

  • Rhinelander Regional Medical Group Onc.

    Rhinelander, Wisconsin, 54501

  • Upstate NY Cancer Research

    Rochester, New York, 14623

  • South Shore Hematology-Oncology Associates

    Rockville Centre, New York, 11570

  • St. Joseph Oncology

    Saint Joseph, Missouri, 64507

  • Christian Hospital

    St Louis, Missouri, 63136

  • St. Johns Mercy Medical Center

    St Louis, Missouri, 63141

  • Summit Medical Group/Overlook Onc Center

    Summit, New Jersey, 07901

  • Santee Hematology Oncology

    Sumter, South Carolina, 29150

  • Hope Center

    Terre Haute, Indiana, 47802

  • Arizona Clinical Research Center

    Tucson, Arizona, 85712

  • New England Hematology / Oncology Associates

    Wellesley, Massachusetts, 02481

Other trials in United States

About this study

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)

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.

Read the 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.

Being tested
rituximab, Pixantrone (BBR 2778)
Keywords
Pixantrone, BBR 2778, chemotherapy, DNA Intercalator, Anthracycline, Rituximab, Rituxan, Mabthera, monoclonal antibody, antibody, NHL, Non-Hodgkin's lymphoma, indolent, low grade, Novuspharma
Medical subject headings
Lymphoma, Follicular, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare the time to tumor progression (TTP) of the combination of BBR 2778 (pixantrone) + rituximab with that of rituximab alone

    Measured: For 5 years post treatment

Secondary outcomes (1)

  1. To compare BBR 2778 + rituximab versus rituximab for:

    • 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

    Measured: For 5 years post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2003 (estimated)
  2. Study startJan 2005
  3. Primary completionJan 2006
  4. Study completionJan 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
800 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00060671
Sponsor's protocol ID
AZA III 02
Status last verified
May 2013
First submitted
9 May 2003
Last updated
19 Jan 2015
Results posted
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rituximab and Pixantrone (BBR 2778) in people with Lymphoma, Follicular and Lymphoma, Mixed-Cell, Follicular, run by CTI BioPharma at 38 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00060671, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2015.

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