Trial intelligence / Profile preview

Revlimid in Relapsed/Refractory Mantle Cell Lymphoma

NCT00737529Phase 2

Key facts

Status: Completed
Start: Dec 2008
Primary completion: Apr 2016
Countries: 14
Sponsor: Celgene Corporation
Modality: Small Molecules

Drugs: lenalidomide
Conditions: mantle cell lymphoma (MCL)

Overview

Phase 2, open-label, single-arm trial of lenalidomide in mantle cell lymphoma (MCL), sponsored by Celgene Corporation. Primary endpoints: Overall Response Rate and Duration of Response. Started Dec 2008; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Lenalidomide
Single agent Revlimid 25mg (or 10mg renal adj) PO daily on days 1-21 of each 28-day cycle

Who it enrols

Patients with biopsy-proven mantle cell lymphoma who have relapsed, progressed, or are refractory to bortezomib, with measurable disease and adequate organ function.

Endpoints

Primary

Overall Response RateUp to 2016-04-06
Duration of ResponseUp to 2016-04-06

Secondary

Complete Response RateUp to 2016-04-06
Duration of Complete ResponseUp to 2016-04-06
Progression-Free SurvivalUp to 2016-04-06
Time to ProgressionUp to 2016-04-06
Time to Treatment FailureUp to 2016-04-06
Time to ResponseUp to 2016-04-06
Time to Complete ResponseUp to 2016-04-06
Overall SurvivalUp to 2017-03-30

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