GM-CSF and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma

August 1, 2013 updated by: French Innovative Leukemia Organisation

An Open Label, Multicenter, Non Randomized Phase II Study to Evaluate Anti-tumor Efficacy and Safety of GM-CSF (Sargramostim, Leukine®) Associated With Rituximab (MabThera®) in Patients With Follicular Non Hodgkin's Lymphoma With no Prior Treatment

RATIONALE: Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving GM-CSF together with rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving GM-CSF together with rituximab works in treating patients with previously untreated follicular non-Hodgkin lymphoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Evaluate the clinical efficacy of sargramostim (GM-CSF) and rituximab, in terms of overall objective complete and partial response rates, in patients with previously untreated follicular non-Hodgkin lymphoma.

Secondary

  • Evaluate the time to progression in patients treated with this regimen.
  • Evaluate the overall survival of patients treated with this regimen.
  • Evaluate the duration of response in patients treated with this regimen.
  • Evaluate the safety profile of this regimen in these patients.
  • Evaluate the influence of FcγR polymorphisms on clinical response.
  • Monitor FcγR-expressing cells in peripheral blood during treatment.
  • Monitor the molecular biological marker bcl2 [t(14;18)] in peripheral blood and bone marrow.

OUTLINE: This is a multicenter study.

  • Induction therapy: Patients receive sargramostim (GM-CSF) subcutaneously (SC) on days 1-5 and rituximab IV on day 1. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
  • Maintenance therapy: Patients receive GM-CSF SC on days 1-5 and rituximab IV on day 1. Treatment repeats every 8 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Blood and bone marrow samples are collected at baseline and periodically during study for analysis of bcl2 rearrangement by PCR assay; FcγR expression by immunophenotyping; and FcγR polymorphisms.

After completion of study therapy, patients are followed every 3 months for 1 year and then every 6 months for up to 4 years.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

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

DISEASE CHARACTERISTICS:

  • Histologically and immunophenotypically confirmed CD20+ follicular lymphoma according to WHO classification

    • Grade 1-3a disease
    • Stage II-IV disease
    • Non-bulky disease
  • Must have undergone initial nodal biopsy within the past 4 months
  • At least 1 measurable lesion

  • Low tumor-burden, as defined by the following GELF criteria:

    • Nodal or extranodal tumor mass (diameter < 7 cm)
    • No systemic B symptoms
    • No increased LDH and β2 microglobulinemia
    • No substantial splenic enlargement
    • No serous effusion
    • No compression syndrome

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active hepatitis

PRIOR CONCURRENT THERAPY:

  • No prior treatment, including steroids and radiotherapy

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: Non-Randomized
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall objective tumor response rate at the end of induction therapy

Secondary Outcome Measures

Outcome Measure
Time to progression
Overall survival
Duration of response
Safety profile
Time to next treatment
Influence of FcγR polymorphisms on clinical response and survival
FcγR expression during study treatment
Molecular biological marker bcl2 [t(14;18)] in peripheral blood and bone marrow as measured by PCR assay

Collaborators and Investigators

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

Sponsor

French Innovative Leukemia Organisation

Investigators

  • Principal Investigator: Jean-Francois Rossi, MD, PhD, Hopital Lapeyronie-CHU Montpellier

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

March 1, 2009

Primary Completion (Anticipated)

March 1, 2011

Study Registration Dates

First Submitted

May 5, 2009

First Submitted That Met QC Criteria

May 5, 2009

First Posted (Estimate)

May 6, 2009

Study Record Updates

Last Update Posted (Estimate)

August 2, 2013

Last Update Submitted That Met QC Criteria

August 1, 2013

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOELAMS-FL2008-RGM
  • CDR0000637112 (Registry Identifier: PDQ (Physician Data Query))
  • EUDRACT-2007-005580-95
  • RECF0906

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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