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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022898-33 | EudraCT Number |
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| Name | Class |
|---|---|
| Celgene | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenalidomide | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenalidomide | Drug | 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. |
| 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). | 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 Any patient in documented progression during treatment will be withdrawn from the trial and declared to be in disease progression for the final evaluation but followed monthly like other participants.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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Week 0 to Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valerie Martinez, MD, PhD | APHP, Hopital Beclere, Clamart France | Principal Investigator |
| Dominique Costagliola, PhD | U943 INSERM and Université Pierre et Marie Curie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valerie Martinez | Clamart | France | 92141 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27405442 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| To estimate the time to the response and the duration of the response | From Week 0 to Week 48 |
| 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. | Week 48 |
| To evaluate the efficacy using ACTG criteria | From Week 0 to Week 48 |
| To evaluate the survival and the survival with no progression | From Week 0 to Week 48 |
| 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 | From Week 0 to Week 48 |
| 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. | From Week 0 to Week 48 |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |