Trial intelligence / Profile preview

GM-CSF + Rituximab in Untreated Follicular Lymphoma

NCT00893477Phase 2

Key facts

Status: Unknown
Start: Mar 2009
Primary completion: Mar 2011
Sponsor: French Innovative Leukemia Organisation
Modality: Recombinant Proteins and Enzymes

Drugs: sargramostim
Conditions: follicular lymphoma (FL)

Overview

Phase 2, open-label, single-arm trial of sargramostim in follicular lymphoma (FL), sponsored by French Innovative Leukemia Organisation. Primary endpoint: Overall objective tumor response rate. Status: unknown.

Design

1 arm

Study design: Non-randomizedOpen-label

GM-CSF + Rituximab
Sargramostim + Rituximab induction and maintenance

Endpoints

Primary

Overall objective tumor response rateEnd of induction therapy

Secondary

Time to progression
Overall survival
Duration of response
Safety profile
Influence of FcγR polymorphisms on clinical response
FcγR-expressing cells in peripheral bloodDuring treatment
Molecular biological marker bcl2 [t(14;18)]

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