Trial intelligence / Profile preview

Lenalidomide in Previously Untreated Advanced Follicular Lymphoma

NCT01180569Phase 2

Key facts

Status: Withdrawn
Start: Aug 2010
Primary completion: May 2011
Sponsor: Memorial Sloan Kettering Cancer Center
Modality: Small Molecules

Drugs: lenalidomide
Conditions: follicular lymphoma (FL)

Overview

Phase 2, open-label, single-arm trial of lenalidomide in follicular lymphoma (FL), sponsored by Memorial Sloan Kettering Cancer Center. Primary endpoint: Response rate (CR + PR) at 2 years. Planned start Aug 2010; status: withdrawn.

Design

1 arm

Study design: Non-randomizedOpen-label

lenalidomide
Lenalidomide monotherapy with dose escalation followed by standard cycles

Who it enrols

Patients with previously untreated, advanced stage follicular lymphoma (grades I, II, or IIIA) with measurable disease and adequate organ function. Excludes grade 3B or aggressive NHL, transformed lymphoma, and prior lymphoma treatment.

Endpoints

Primary

Response rate (CR + PR)2 years

Secondary

Response rate (CR + PR) and time to disease progression2 years
Immune monitoring and analysis of signal transduction in the lymph node2 years
Immune monitoring and analysis of signal transduction in the blood2 years

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