Back to resultsGM-CSF, Rituximab, and Combination Chemotherapy in Treating Patients With Previously Untreated Advanced Follicular Non-Hodgkin Lymphoma
Primary Purpose
Lymphoma
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
rituximab
sargramostim
cyclophosphamide
doxorubicin hydrochloride
prednisone
vincristine sulfate
gene expression analysis
gene rearrangement analysis
polymerase chain reaction
R-CHOP regimen
laboratory biomarker analysis
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring 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 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.
PATIENT CHARACTERISTICS:
- 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
PRIOR CONCURRENT THERAPY:
- 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
Sites / Locations
Outcomes
Primary Outcome Measures
Overall objective tumor response rate
Secondary Outcome Measures
Time to treatment progression
Overall survival
Duration of response
Time to next treatment
Safety profile
Influence of FcγR polymorphisms on clinical response and overall survival
Monitoring of FcγR expressing cells during treatment
Quantitative monitoring of the molecular biological marker bcl-2 in peripheral blood and bone marrow by PCR assay
Full Information
NCT ID
NCT00896519
First Posted
May 8, 2009
Last Updated
August 1, 2013
Sponsor
French Innovative Leukemia Organisation
1. Study Identification
Unique Protocol Identification Number
NCT00896519
Brief Title
GM-CSF, Rituximab, and Combination Chemotherapy in Treating Patients With Previously Untreated Advanced Follicular Non-Hodgkin Lymphoma
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 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: 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.
Detailed Description
OBJECTIVES:
Primary
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.
Secondary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
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
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Type
Biological
Intervention Name(s)
sargramostim
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
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
Other
Intervention Name(s)
R-CHOP regimen
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Primary Outcome Measure Information:
Title
Overall objective tumor response rate
Secondary Outcome Measure Information:
Title
Time to treatment 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 overall survival
Title
Monitoring of FcγR expressing cells during treatment
Title
Quantitative monitoring of the molecular biological marker bcl-2 in peripheral blood and bone marrow by PCR assay
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
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.
PATIENT CHARACTERISTICS:
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
PRIOR CONCURRENT THERAPY:
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
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, Rituximab, and Combination Chemotherapy in Treating Patients With Previously Untreated Advanced Follicular Non-Hodgkin Lymphoma
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