Trial record 10 of 35 for:    " December 22, 2010":" January 21, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
  Purpose

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.


Condition Intervention Phase
HIV Infection Associated Kaposi Disease
Drug: Lenalidomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

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    Any patient in documented progression during treatment will be withdrawn from the trial and declared to be in disease progression for the final evaluation but followed monthly like other participants.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



Secondary Outcome Measures:
  • 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.



Estimated Enrollment: 35
Study Start Date: October 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01282047

Locations
France
Valerie Martinez
Clamart, France, 92141
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Celgene Corporation
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
  More Information

Additional Information:
No publications provided

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     History of Changes
Other Study ID Numbers: 2010-022898-33, ANRS 154 LENAKAP
Study First Received: January 21, 2011
Last Updated: July 17, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
Lenalidomide
Kaposi
HIV
efficacy
safety

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Xeroderma Pigmentosum
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Precancerous Conditions
Neoplasms
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Photosensitivity Disorders
Skin Diseases
Pigmentation Disorders
DNA Repair-Deficiency Disorders
Metabolic Diseases
Lenalidomide
Thalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 29, 2014