Multicenter, Open Label, Phase II Trial to Evaluate the Efficacy and Safety of Treatment With Lenalidomide in Kaposi Disease Associated With HIV Infection (ANRS 154/LENAKAP)
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.
The observation period is 48 weeks. The main criteria is evaluated at 24 weeks Inclusion
period: 72 weeks from the setting-up meeting.Lenalidomide will be stopped in the case of
progression and the patients will be considered as drop-out from the trial, but will be
taken into account in the final analysis.
Two-steps procedure: 14 evaluable patients in the first step; if one response to treatment
is observed, other patients are included up to 25 evaluable patients.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the efficacy of treatment with Lenalidomide in progressive Kaposi disease in Human immunodeficiency virus (HIV)-infected patients receiving Combined Antiretroviral Therapy (cART).
For all patients clinical tumour evaluation : complete clinical examination, tumour scoring according to the Aids Clinical Trials Group (ACTG) and The Physician's Global Assessment (PGA) and laboratory assessment. Any patient in documented progression during treatment will be withdrawn from the trial and declared to be in disease progression for the final evaluation but followed monthly like other participants. Such patients will be treated under the physician's responsability.
Clinical benefit at week 24
Valerie Martinez, MD, PhD
APHP, Hopital Beclere, Clamart France
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)