NCT00893477

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 lymphoma

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Last Updated

August 2, 2013

Status Verified

July 1, 2009

Enrollment Period

2 years

First QC Date

May 5, 2009

Last Update Submit

August 1, 2013

Conditions

Lymphoma

Keywords

stage II grade 1 follicular lymphomastage II grade 2 follicular lymphomastage II grade 3 follicular lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphoma

Outcome Measures

Primary Outcomes (1)

  • Overall objective tumor response rate at the end of induction therapy

Secondary Outcomes (8)

  • Time to progression

  • Overall survival

  • Duration of response

  • Time to next treatment

  • Safety profile

  • +3 more secondary outcomes

Interventions

rituximabBIOLOGICAL
sargramostimBIOLOGICAL
gene expression analysisGENETIC
gene rearrangement analysisGENETIC
polymerase chain reactionGENETIC
polymorphism analysisGENETIC
laboratory biomarker analysisOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

LymphomaLymphoma, Follicular

Interventions

RituximabsargramostimGene Expression ProfilingGene RearrangementPolymerase Chain ReactionAmplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsGenetic TechniquesInvestigative TechniquesGenetic PhenomenaNucleic Acid Amplification TechniquesDNA Fingerprinting

Study Officials

  • Jean-Francois Rossi, MD, PhD

    Hopital Lapeyronie-CHU Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 5, 2009

First Posted

May 6, 2009

Study Start

March 1, 2009

Primary Completion

March 1, 2011

Last Updated

August 2, 2013

Record last verified: 2009-07