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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00893477
• Other study ID #: GOELAMS-FL2008-RGM
• Secondary ID: CDR0000637112EUD
• Status: Not yet recruiting
• Phase: Phase 2
• First received: May 5, 2009
• Last updated: August 1, 2013
• Start date: March 2009

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ß2 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

Study Design

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular
• Lymphoma, Non-Hodgkin

Intervention

Biological:
• rituximab

• sargramostim

Genetic:
• gene expression analysis

• gene rearrangement analysis

• polymerase chain reaction

• polymorphism analysis

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall objective tumor response rate at the end of induction therapy			No
Secondary	Time to progression			No
Secondary	Overall survival			No
Secondary	Duration of response			No
Secondary	Time to next treatment			No
Secondary	Safety profile			Yes
Secondary	Influence of Fc?R polymorphisms on clinical response and survival			No
Secondary	Fc?R expression during study treatment			No
Secondary	Molecular biological marker bcl2 [t(14;18)] in peripheral blood and bone marrow as measured by PCR assay			No