GM-CSF, Rituximab, and Combination Chemotherapy in Treating Patients With Previously Untreated Advanced Follicular Non-Hodgkin Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00896519
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Not yet recruiting
First Posted : May 11, 2009
Last Update Posted : August 2, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: 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. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as GM-CSF, may cause the body to make more blood cells and help it recover from the side effects of rituximab and combination chemotherapy.

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

Condition or disease Intervention/treatment Phase
Lymphoma Biological: rituximab Biological: sargramostim Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate Genetic: gene expression analysis Genetic: gene rearrangement analysis Genetic: polymerase chain reaction Other: R-CHOP regimen Other: laboratory biomarker analysis Phase 2

Detailed Description:



  • To evaluate the overall objective tumor response rate (complete and partial response rates) in patients with previously untreated advanced follicular non-Hodgkin lymphoma treated with sargramostim (GM-CSF) and R-CHOP.


  • To evaluate the time to progression.
  • To evaluate the overall survival.
  • To evaluate the duration of response.
  • To evaluate the time to next treatment.
  • To evaluate the safety profile of GM-CSF in combination with R-CHOP.
  • To evaluate the influence of FcγR polymorphisms on clinical response.
  • To monitor FcγR expressing cells in peripheral blood during treatment.
  • To monitor the molecular biological marker bcl-2 [t(14;18)] in peripheral blood and bone marrow by quantitative PCR assay.

OUTLINE: This is a multicenter study.

  • Induction therapy: Patients receive R-CHOP comprising rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1 and oral prednisone on days 1-5. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) on days 2-6. Treatment repeats every 21 days for up to 6 courses. Patients then receive rituximab IV on day 1 and GM-CSF SC on days 1-5. Treatment with rituximab and GM-CSF repeats every 21 days for 2 courses. Patients achieving complete or partial response proceed to maintenance therapy.
  • Maintenance therapy: Patients receive rituximab IV on day 1 and GM-CSF SC on days 1-5. Treatment repeats every 2 months for 12 courses.

Blood and bone marrow samples are collected at baseline and periodically during study for analysis of FcγR expression by immunophenotyping and bcl-2 rearrangement by quantitative PCR.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Multicenter, Non Randomized Phase II Study to Evaluate Antitumor Efficacy and Safety of GM-CSF (Sargramostim, Leukine®) Associated With RCHOP Chemotherapy and Rituximab (MabThera®) Maintenance in Patients With First-line Advanced Follicular Non Hodgkin's Lymphoma
Study Start Date : March 2009
Estimated Primary Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Primary Outcome Measures :
  1. Overall objective tumor response rate

Secondary Outcome Measures :
  1. Time to treatment progression
  2. Overall survival
  3. Duration of response
  4. Time to next treatment
  5. Safety profile
  6. Influence of FcγR polymorphisms on clinical response and overall survival
  7. Monitoring of FcγR expressing cells during treatment
  8. Quantitative monitoring of the molecular biological marker bcl-2 in peripheral blood and bone marrow by PCR assay

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed follicular non-Hodgkin lymphoma

    • Grade 1-3a disease
    • Advanced disease
  • Has undergone initial lymph node biopsy within the past 4 months
  • At least 1 measurable lesion
  • Bulky disease, as defined by the following GELF criteria:

    • Nodal or extranodal mass > 7 cm in its greatest diameter
    • Involvement of ≥ 3 nodal sites (each with a diameter > 3 cm)
    • B symptoms
    • Elevated serum LDH or β2-microglobulin
    • Splenic enlargement
    • Compression syndrome
    • Pleural and/or peritoneal effusion
  • No transformation to high-grade follicular lymphoma (secondary to low-grade follicular lymphoma)
  • No prior or concurrent CNS disease (i.e., CNS lymphoma or lymphomatous meningitis) NOTE: A new classification scheme for adult non-Hodgkin lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.


  • ECOG performance status 0-1
  • Life expectancy ≥ 6 months
  • ANC ≥ 1,000/mm^3*
  • Platelet count ≥ 100,000/mm^3*
  • Hemoglobin ≥ 8.0 g/dL*
  • Total bilirubin ≤ 2.0 mg/dL*
  • AST ≤ 3 times upper limit of normal*
  • Serum creatinine ≤ 2.0 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 12 months after completion of study treatment
  • No known HIV infection
  • No active hepatitis B or C infection
  • No serious underlying medical condition that would preclude study participation (e.g., ongoing infection, uncontrolled diabetes mellitus, gastric ulcer, active autoimmune disease, or heart failure)
  • No known sensitivity or allergy to murine products
  • No other prior or concurrent malignancies except nonmelanoma skin cancer or adequately treated in situ cervical cancer
  • No other co-existing medical or psychological condition that would preclude study participation or ability to give informed consent NOTE: *Unless abnormalities are related to lymphoma


  • See Disease Characteristics
  • No prior treatment for follicular lymphoma, including steroids or radiotherapy
  • More than 4 weeks since prior corticosteroids unless administered at a dose equivalent to < 20 mg/day of prednisone
  • More than 28 days since prior major surgery (excluding lymph node biopsy)
  • More than 30 days since prior treatment in a clinical trial

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 identifier (NCT number): NCT00896519

Sponsors and Collaborators
French Innovative Leukemia Organisation
Principal Investigator: Jean-Francois Rossi, MD, PhD Hopital Lapeyronie-CHU Montpellier Identifier: NCT00896519     History of Changes
Other Study ID Numbers: GOELAMS-FL2008-RCHOP-GM
CDR0000637105 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: May 11, 2009    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
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, Non-Hodgkin
Lymphoma, Follicular
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents