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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00893477
First received: May 5, 2009
Last updated: August 1, 2013
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Lymphoma
Biological: rituximab
Biological: sargramostim
Genetic: gene expression analysis
Genetic: gene rearrangement analysis
Genetic: polymerase chain reaction
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall objective tumor response rate at the end of induction therapy [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Time to next treatment [ Designated as safety issue: No ]
  • Safety profile [ Designated as safety issue: Yes ]
  • Influence of FcγR polymorphisms on clinical response and survival [ Designated as safety issue: No ]
  • FcγR expression during study treatment [ Designated as safety issue: No ]
  • Molecular biological marker bcl2 [t(14;18)] in peripheral blood and bone marrow as measured by PCR assay [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2009
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893477

Sponsors and Collaborators
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Investigators
Principal Investigator: Jean-Francois Rossi, MD, PhD Hopital Lapeyronie-CHU Montpellier
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00893477     History of Changes
Other Study ID Numbers: GOELAMS-FL2008-RGM, CDR0000637112, EUDRACT-2007-005580-95, RECF0906
Study First Received: May 5, 2009
Last Updated: August 1, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage II grade 1 follicular lymphoma
stage II grade 2 follicular lymphoma
stage II grade 3 follicular lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 11, 2014