Clinical trial NCT01282047: Lenalidomide in Kaposi Disease Associated With HIV Infection
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: HIV Infection Associated Kaposi Disease
Keywords: Lenalidomide
Kaposi
HIV
efficacy
safety
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Celgene Corporation
First posted: 2011-01-24
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the efficacy of treatment with Lenalidomide in progressive Kaposi disease in Human immunodeficiency virus (HIV)-infected patients receiving Combined Antiretroviral Therapy (cART).
timeFrame: Clinical benefit at week 24
Secondary outcomes:
measure: To estimate the safety of lenalidomide
timeFrame: From Week 0 to Week 48
measure: To estimate the time to the response and the duration of the response
timeFrame: From Week 0 to Week 48
measure: To evaluate the efficacy of treatment at 48 weeks
timeFrame: Week 48
measure: To evaluate the efficacy using ACTG criteria
timeFrame: From Week 0 to Week 48
measure: To evaluate the survival and the survival with no progression
timeFrame: From Week 0 to Week 48
measure: To describe the evolution of virologic and immunological parameters
timeFrame: From Week 0 to Week 48
measure: To estimate the safety of lenalidomide
timeFrame: From Week 0 to Week 48
Other outcomes:
Locations:
city: Clamart
country: France
facility: Valerie Martinez
Study officials:
affiliation: APHP, Hopital Beclere, Clamart France
name: Valerie Martinez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: U943 INSERM and Université Pierre et Marie Curie
name: Dominique Costagliola, PhD
role: STUDY_DIRECTOR
References:
citation: 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.