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

Sponsored by:	Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00893477

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 II

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Granulocyte-macrophage colony-stimulating factor Sargramostim Rituximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label
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

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 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 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 sargramostim 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

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

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

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

Study placed in the following topic categories:

Lymphoma, Small Cleaved-cell, Diffuse
Lymphatic Diseases
Immunoproliferative Disorders
Immunologic Factors
Rituximab
Lymphoma, Follicular

Antirheumatic Agents
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Follicular Lymphoma
Lymphoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Rituximab
Physiological Effects of Drugs
Lymphoma, Follicular

Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Antirheumatic Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on May 07, 2009