GM-CSF and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma
Primary Purpose
Lymphoma
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
rituximab
sargramostim
gene expression analysis
gene rearrangement analysis
polymerase chain reaction
polymorphism analysis
laboratory biomarker analysis
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring 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
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Overall objective tumor response rate at the end of induction therapy
Secondary Outcome Measures
Time to progression
Overall survival
Duration of response
Time to next treatment
Safety profile
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
Full Information
NCT ID
NCT00893477
First Posted
May 5, 2009
Last Updated
August 1, 2013
Sponsor
French Innovative Leukemia Organisation
1. Study Identification
Unique Protocol Identification Number
NCT00893477
Brief Title
GM-CSF and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
French Innovative Leukemia Organisation
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Type
Biological
Intervention Name(s)
sargramostim
Intervention Type
Genetic
Intervention Name(s)
gene expression analysis
Intervention Type
Genetic
Intervention Name(s)
gene rearrangement analysis
Intervention Type
Genetic
Intervention Name(s)
polymerase chain reaction
Intervention Type
Genetic
Intervention Name(s)
polymorphism analysis
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Primary Outcome Measure Information:
Title
Overall objective tumor response rate at the end of induction therapy
Secondary Outcome Measure Information:
Title
Time to progression
Title
Overall survival
Title
Duration of response
Title
Time to next treatment
Title
Safety profile
Title
Influence of FcγR polymorphisms on clinical response and survival
Title
FcγR expression during study treatment
Title
Molecular biological marker bcl2 [t(14;18)] in peripheral blood and bone marrow as measured by PCR assay
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Francois Rossi, MD, PhD
Organizational Affiliation
Hopital Lapeyronie-CHU Montpellier
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
GM-CSF and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma
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