Trial intelligence / Profile preview

Lenalidomide + CHOEP for Frontline PTCL

NCT02561273Phase 2

Key facts

Status: Completed
Start: Sep 2015
Primary completion: Nov 2019
Countries: 1
Sponsor: University of Nebraska
Modality: Small Molecules

Drugs: lenalidomide
Conditions: peripheral T-cell lymphoma (PTCL)

Overview

Phase 2, open-label, single-arm trial of lenalidomide in peripheral T-cell lymphoma (PTCL), sponsored by University of Nebraska. Primary endpoints: Maximum Tolerated Dose of Lenalidomide and CHOEP at 21 days, Number of Participants With Adverse Events up to 5 months and 2 more. Started Sep 2015; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Lenalidomide + CHOEP
Induction with Lenalidomide + CHOEP, followed by Maintenance Lenalidomide or ASCT

Who it enrols

Patients with newly diagnosed stage II-IV peripheral T-cell lymphoma, adequate organ function, and no prior systemic therapy (except radiation/prednisone).

Endpoints

Primary

Maximum Tolerated Dose of Lenalidomide and CHOEP21 days
Number of Participants With Adverse EventsUp to 5 months
Complete Response Rate18 weeks
Overall Response Rate18 weeks

Secondary

Number of Participants With Adverse Events (Phase II)Up to 1 year
Overall SurvivalUp to 1 year
Progression-free SurvivalUp to 2 years

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