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Lenalidomide in Kaposi Disease Associated With HIV Infection (LENAKAP)

Primary Purpose

HIV Infection Associated Kaposi Disease

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Lenalidomide
Sponsored by
French National Agency for Research on AIDS and Viral Hepatitis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection Associated Kaposi Disease focused on measuring Lenalidomide, Kaposi, HIV, efficacy, safety

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Valerie Martinez

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lenalidomide

Arm Description

Outcomes

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).
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
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
To evaluate the efficacy of treatment at 48 weeks
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
To evaluate the survival and the survival with no progression
To describe the evolution of virologic and immunological parameters
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
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.

Full Information

First Posted
January 21, 2011
Last Updated
July 31, 2014
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators
Celgene Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01282047
Brief Title
Lenalidomide in Kaposi Disease Associated With HIV Infection
Acronym
LENAKAP
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Terminated
Study Start Date
October 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators
Celgene Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection Associated Kaposi Disease
Keywords
Lenalidomide, Kaposi, HIV, efficacy, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lenalidomide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate the efficacy of treatment with Lenalidomide in progressive Kaposi disease in Human immunodeficiency virus (HIV)-infected patients receiving Combined Antiretroviral Therapy (cART).
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.
Time Frame
Clinical benefit at week 24
Secondary Outcome Measure Information:
Title
To estimate the safety of lenalidomide
Description
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.
Time Frame
From Week 0 to Week 48
Title
To estimate the time to the response and the duration of the response
Time Frame
From Week 0 to Week 48
Title
To evaluate the efficacy of treatment at 48 weeks
Description
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.
Time Frame
Week 48
Title
To evaluate the efficacy using ACTG criteria
Time Frame
From Week 0 to Week 48
Title
To evaluate the survival and the survival with no progression
Time Frame
From Week 0 to Week 48
Title
To describe the evolution of virologic and immunological parameters
Description
To describe the evolution of virologic and immunological parameters: CD4 and CD8 cell counts, Plasma HIV and HHV8 loads
Time Frame
From Week 0 to Week 48
Title
To estimate the safety of lenalidomide
Description
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.
Time Frame
From Week 0 to Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie Martinez, MD, PhD
Organizational Affiliation
APHP, Hopital Beclere, Clamart France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dominique Costagliola, PhD
Organizational Affiliation
U943 INSERM and Université Pierre et Marie Curie
Official's Role
Study Director
Facility Information:
Facility Name
Valerie Martinez
City
Clamart
ZIP/Postal Code
92141
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
27405442
Citation
Pourcher V, Desnoyer A, Assoumou L, Lebbe C, Curjol A, Marcelin AG, Cardon F, Gibowski S, Salmon D, Chennebault JM, Poizot-Martin I, Peytavin G, Boue F, Costagliola D. Phase II Trial of Lenalidomide in HIV-Infected Patients with Previously Treated Kaposi's Sarcoma: Results of the ANRS 154 Lenakap Trial. AIDS Res Hum Retroviruses. 2017 Jan;33(1):1-10. doi: 10.1089/AID.2016.0069. Epub 2016 Sep 7.
Results Reference
derived
Links:
URL
http://www.anrs.fr
Description
Related Info

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Lenalidomide in Kaposi Disease Associated With HIV Infection

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