Lenalidomide in Kaposi Disease Associated With HIV Infection (LENAKAP)

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase: Terminated; Phase 2

Conditions: HIV Infection Associated Kaposi Disease

Treatments: Drug: Lenalidomide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01282047

2010-022898-33

ANRS 154 LENAKAP

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 12 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men or non childbearing (negative serum Human Chorionic Gonadotropin-hCG) non breastfeeding women who practice adequate birth control, maintained 4 weeks after stopping lenalidomide
• Age over 18 years and below 75 years
• Able and willing to give written informed consent
• Serologic documentation of HIV infection by approved tests, undetectable HIV viral load (below 50 copies/mL) independently of CD4 cell counts
• Biopsy proven symptomatic Kaposi sarcoma with at least 4 measurable cutaneous lesions
• Treatment by cART for at least 12 months, without wash out the last 6 months with undetectable HIV-RNA (below 50 copies/mL)
• History of treatment failure or relapse with 1 or more chemotherapy
• Progressive disease with need to new specific therapy
• Wash-out over 4 weeks if previous specific Kaposi sarcoma chemotherapy (8 weeks if Interferon -IFN therapy)
• Karnofsky performance status over 70%
• Social security (State Medical Assistance is not a social security scheme)
• Agree to abstain from donating blood
• Agree not to donate semen
• Agree not to share study drug with another person

Exclusion criteria

• Childbearing or breastfeeding (positive betaHCG serum)
• Kaposi sarcoma with only visceral locations
• Kaposi sarcoma with cardiac and/or bronchopulmonary localisations
• 2 viral loads over 50 copies/mL under Highly active antiretroviral therapy (HAART), during the last 6 months
• Opportunistic infections, uncontrolled infections
• Cardiac disease
• Castleman disease or lymphoma
• Other cancers or previous or current haematological malignancies
• Polyneuritis, grade over 2
• Association with neurotoxic drugs such as isoniazid, d4T
• Neutrophil polynuclear count below 1000/mm3 or platelets below 75000/mm3
• Life expectation under 2 months
• Creatinine clearance below or equal 50 mL/min (Cockcroft-Gault formula)
• Serum Glutamopyruvate Transferase (SGPT) or Serum Glutamooxaloacetate Transferase (SGOT) over or equal 3
• Concomitant treatment with antineoplastic drugs
• Known allergy or hypersensitivity to aspirin, to lenalidomide
• Contraindication to anticoagulant drugs
• Safeguard justice

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Lenalidomide

Experimental group

Treatment:

Drug: Lenalidomide