Lenalidomide in Kaposi Disease Associated With HIV Infection (LENAKAP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )
ClinicalTrials.gov Identifier:
NCT01282047
First received: January 21, 2011
Last updated: July 17, 2013
Last verified: July 2013

January 21, 2011
July 17, 2013
October 2011
October 2013   (final data collection date for primary 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). [ Time Frame: Clinical benefit at week 24 ] [ Designated as safety issue: Yes ]

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Any patient in documented progression during treatment will be withdrawn from the trial and declared to be in disease progression for the final evaluation but followed monthly like other participants.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.

Evaluate the efficacy of treatment with Lenalidomide in progressive Kaposi disease in HIV-infected patients receiving cART [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]

For all patients clinical tumour evaluation (complete clinical examination, ACTG and PGA scoring) laboratory assessment and CT scans will be performed by the investigator

Any patient in documented progression during treatment will be withdrawn from the trial and declared to be in disease progression for the final evaluation but followed monthly like other participants.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 responsibility.

Complete list of historical versions of study NCT01282047 on ClinicalTrials.gov Archive Site
  • To estimate the safety of lenalidomide [ Time Frame: From Week 0 to Week 48 ] [ Designated as safety issue: Yes ]

    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.

  • To estimate the time to the response and the duration of the response [ Time Frame: From Week 0 to Week 48 ] [ Designated as safety issue: Yes ]
  • To evaluate the efficacy of treatment at 48 weeks [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
    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.
  • To evaluate the efficacy using ACTG criteria [ Time Frame: From Week 0 to Week 48 ] [ Designated as safety issue: Yes ]
  • To evaluate the survival and the survival with no progression [ Time Frame: From Week 0 to Week 48 ] [ Designated as safety issue: Yes ]
  • To describe the evolution of virologic and immunological parameters [ Time Frame: From Week 0 to Week 48 ] [ Designated as safety issue: Yes ]

    To describe the evolution of virologic and immunological parameters:

    CD4 and CD8 cell counts, Plasma HIV and HHV8 loads

  • To estimate the safety of lenalidomide [ Time Frame: From Week 0 to Week 48 ] [ Designated as safety issue: Yes ]

    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.

  • To estimate the safety of lenalidomide [ Time Frame: From Week 0 to Week 48 ] [ Designated as safety issue: Yes ]
  • To estimate the time to the response and the duration of the response [ Time Frame: From Week 0 to Week 48 ] [ Designated as safety issue: Yes ]
  • To evaluate the efficacy of treatment at 48 weeks [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  • To evaluate the efficacy using ACTG criteria [ Time Frame: From Week 0 to Week 48 ] [ Designated as safety issue: Yes ]
  • To evaluate the survival and the survival with no progression [ Time Frame: From Week 0 to Week 48 ] [ Designated as safety issue: Yes ]
  • To describe the evolution of virologic and immunological parameters [ Time Frame: From Week 0 to Week 48 ] [ Designated as safety issue: Yes ]

    To describe the evolution of virologic and immunological parameters:

    CD4 and CD8 cell counts, HIV-RNA HHV-8 PCR

Not Provided
Not Provided
 
Lenalidomide in Kaposi Disease Associated With HIV Infection
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection Associated Kaposi Disease
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.
Experimental: Lenalidomide
Intervention: Drug: Lenalidomide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
35
April 2014
October 2013   (final data collection date for primary outcome measure)

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
Both
19 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01282047
2010-022898-33, ANRS 154 LENAKAP
Yes
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )
French National Agency for Research on AIDS and Viral Hepatitis
Celgene Corporation
Principal Investigator: Valerie Martinez, MD, PhD APHP, Hopital Beclere, Clamart France
Study Director: Dominique Costagliola, PhD U943 INSERM and Université Pierre et Marie Curie
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP