Lenalidomide in Kaposi Disease Associated With HIV Infection

NCT01282047 | Terminated Phase 2 DMC

• 2 other identifiers: 2010-022898-33ANRS 154 LENAKAP
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infection Associated Kaposi Disease

Keywords

Lenalidomide; Kaposi; HIV; efficacy; safety

Outcome Measures

Primary Outcomes (1)

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 Any patient in documented progression during treatment will be withdrawn from the trial and declared to be in disease progression for the final evaluation but followed monthly like other participants.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

Secondary Outcomes (7)

• To estimate the safety of lenalidomide

  From Week 0 to Week 48

• 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

  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

Study Arms (1)

Lenalidomide

EXPERIMENTAL

Drug: Lenalidomide

Interventions

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.

Lenalidomide

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Childbearing or breastfeeding (positive betaHCG serum)
• Kaposi sarcoma with only visceral locations
• Kaposi sarcoma with cardiac and/or bronchopulmonary localisations
• 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

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead
• Celgene Corporation: collaborator

Study Sites (1)

Valerie Martinez

Clamart, France, 92141, France

Location

Related Publications (1)

• 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.

  PMID: 27405442 DERIVED

Related Links

• Related Info

MeSH Terms

Interventions

Lenalidomide

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Valerie Martinez, MD, PhD

  APHP, Hopital Beclere, Clamart France

  PRINCIPAL INVESTIGATOR

• Dominique Costagliola, PhD

  U943 INSERM and Université Pierre et Marie Curie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2011
• First Posted: January 24, 2011
• Study Start: October 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: August 1, 2014

Record last verified: 2014-07

Locations

FR (1)