Lenalidomide in Kaposi Disease Associated With HIV Infection

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01282047
• Date of registration: 21/01/2011
• Prospective Registration: Yes
• Primary sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Public title: Lenalidomide in Kaposi Disease Associated With HIV Infection LENAKAP
• Scientific 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)
• Date of first enrolment: October 2011
• Target sample size: 12
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01282047
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Valerie Martinez, MD, PhD
• Affiliation: APHP, Hopital Beclere, Clamart France

• Name: Dominique Costagliola, PhD
• Affiliation: U943 INSERM and Université Pierre et Marie Curie

Key inclusion & exclusion 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



Age minimum: 19 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infection Associated Kaposi Disease

Intervention(s)

Drug: Lenalidomide

Primary Outcome(s)

Evaluate the efficacy of treatment with Lenalidomide in progressive Kaposi disease in Human immunodeficiency virus (HIV)-infected patients receiving Combined Antiretroviral Therapy (cART). [Time Frame: Clinical benefit at week 24]

Secondary Outcome(s)

To describe the evolution of virologic and immunological parameters [Time Frame: From Week 0 to Week 48]

To evaluate the efficacy of treatment at 48 weeks [Time Frame: Week 48]

To evaluate the efficacy using ACTG criteria [Time Frame: From Week 0 to Week 48]

To evaluate the survival and the survival with no progression [Time Frame: From Week 0 to Week 48]

To estimate the safety of lenalidomide [Time Frame: From Week 0 to Week 48]

To estimate the time to the response and the duration of the response [Time Frame: From Week 0 to Week 48]

Secondary ID(s)

2010-022898-33

ANRS 154 LENAKAP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Celgene Corporation