drugset / Trial / NCT01553786

Efficacy of a Treatment With CHOP and Lenalidomide in First Line in Angioimmunoblastic T-cell Lymphoma (AITL)

NCT01553786 ↗

Phase 2 Completed 80 enrolled The Lymphoma Academic Research Organisation
NaSingle-groupOpen-labelTreatment

Summary

This study aims to evaluate the efficacy of lenalidomide associated with CHOP as measured by complete response rate at the end of treatment. Approximately 80 patients aged between 60 and 80 years will be included, to have 70 evaluable patients. The treatment consists of two phases of four 3-weeks cycles: induction phase and consolidation phase, for a total treatment duration of 24 weeks. Each cycle will be broken down as follows: chemotherapy will be administered in the hospital on day 1, prednisone is continued for 5 days and lenalidomide is taken for 14 days. Patients will be followed for at least 18 months after inclusion of the last patient.

Timeline

Start
2011-11
Primary completion
2018-03
Completion
2019-03-21

Outcome

Missed primary endpoint

paper CMR was achieved in 32 (41%; 95% confidence interval [CI], 30%-52.7%) patients, which was below the prespecified CMR rate of 55% defined as success in the study. PMID 33496747 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenalidomide Other / unclassified 25 mg —