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
Recruitment status was Not yet recruiting
Sponsor:
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00893477
First received: May 5, 2009
Last updated: July 7, 2009
Last verified: July 2009
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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) |
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 More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00893477 History of Changes |
| Other Study ID Numbers: | CDR0000637112, GOELAMS-FL2008-RGM, EUDRACT-2007-005580-95, RECF0906 |
| Study First Received: | May 5, 2009 |
| Last Updated: | July 7, 2009 |
| 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 Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 16, 2013