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)
19 Years
75 Years
Both
HIV Infection Associated Kaposi Disease
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Evaluate the efficacy of treatment with Lenalidomide in progressive Kaposi disease in Human immunodeficiency virus (HIV)-infected patients receiving Combined Antiretroviral Therapy (cART).
Outcome Description:
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.
Outcome Time Frame:
Clinical benefit at week 24
Safety Issue:
Yes
Principal Investigator
Valerie Martinez, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
APHP, Hopital Beclere, Clamart France
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
2010-022898-33
NCT ID:
NCT01282047
Start Date:
October 2011
Completion Date:
April 2014
Related Keywords:
- HIV Infection Associated Kaposi Disease
- Lenalidomide
- Kaposi
- HIV
- efficacy
- safety
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Xeroderma Pigmentosum
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