Lenalidomide in Kaposi Disease Associated With HIV Infection

NCT01282047 ↗

Phase 2 Terminated 12 enrolled French National Agency for Research on AIDS and Viral Hepatitis Celgene Corporation · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Lenakap : This multicenter, non randomized (single arm), open, phase II study aims to evaluated the efficacy of Lenalidomide in HIV-associated kaposi disease. Patients will be followed for 48 weeks. Measurement of primary endpoint will be at 24 weeks.

Timeline

Start: 2011-10
Primary completion: 2014-02
Completion: 2014-02

Outcome

Missed primary endpoint

paper The remaining 10 patients were assessable at week 24, when none had PGA-defined CR or PR. PMID 27405442 ↗

paper The ACTG-defined response rate at week 48 was 40%, while it was 0% using PGA criteria. PMID 27405442 ↗

Publications

Pourcher V, Desnoyer A, Assoumou L, Lebbe C, Curjol A, Marcelin AG, Cardon F, Gibowski S, Salmon D, Chennebault JM, Poizot-Martin I, Peytavin G, Boue F, Costagliola D. Phase II Trial of Lenalidomide in HIV-Infected Patients with Previously Treated Kaposi's Sarcoma: Results of the ANRS 154 Lenakap Trial. AIDS Res Hum Retroviruses. 2017 Jan;33(1):1-10. doi: 10.1089/AID.2016.0069. Epub 2016 Sep 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lenalidomide	Other / unclassified	25 mg	Oral