Lenalidomide in Kaposi Disease Associated With HIV Infection (LENAKAP)

April 2, 2026 updated by: French National Agency for Research on AIDS and Viral Hepatitis

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • France
      • Clamart, France, France, 92141
        • Valerie Martinez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lenalidomide
Drug: Lenalidomide
oral course, 25 mg, day 1 to 21, per month, 7 days of wash-out each month. Duration according to initial response: 24 weeks and 12 weeks more if complete remission, 24 weeks more if partial remission or stable disease and stop in case of progression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To estimate the safety of lenalidomide
Time Frame: From Week 0 to Week 48

All patients that have started one dose of active treatment will be included in the analysis of safety.

Adverse event will be described precisely for each patient and for each event according to ANRS adverse events criteria. A descriptive analysis of each laboratory result and vital signs will be provided.
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
From Week 0 to Week 48
To evaluate the efficacy of treatment at 48 weeks
Time Frame: Week 48
The analysis of efficacy will determine the proportion of patients with objective response according to the Physical Global Assessment (PGA) score at week 24 and using ACTG criteria for Kaposi.
Week 48
To evaluate the efficacy using ACTG criteria
Time Frame: From Week 0 to Week 48
From Week 0 to Week 48
To evaluate the survival and the survival with no progression
Time Frame: From Week 0 to Week 48
From Week 0 to Week 48
To describe the evolution of virologic and immunological parameters
Time Frame: From Week 0 to Week 48

To describe the evolution of virologic and immunological parameters:

CD4 and CD8 cell counts, Plasma HIV and HHV8 loads
From Week 0 to Week 48
To estimate the safety of lenalidomide
Time Frame: From Week 0 to Week 48

All patients that have started one dose of active treatment will be included in the analysis of safety.

Adverse event will be described precisely for each patient and for each event according to French AIDS Agency (ANRS) adverse events criteria. A descriptive analysis of each laboratory result and vital signs will be provided.
From Week 0 to Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Collaborators

Celgene

Investigators

  • Principal Investigator: Valerie Martinez, MD, PhD, APHP, Hopital Beclere, Clamart France
  • Study Director: Dominique Costagliola, PhD, U943 INSERM and Université Pierre et Marie Curie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

January 21, 2011

First Submitted That Met QC Criteria

January 21, 2011

First Posted (Estimated)

January 24, 2011

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS 154 LENAKAP
  • 2010-022898-33 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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