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Cancer drug lenalidomide tested for HIV-Linked kaposi sarcoma

NCT ID NCT01282047

Disease control Sponsor: French National Agency for Research on AIDS and Viral Hepatitis Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested the drug lenalidomide in 12 people with HIV who had Kaposi sarcoma, a type of cancer. Participants took lenalidomide pills for 21 days each month. The study aimed to see if the drug could shrink tumors, but it was stopped early, so the results are not conclusive.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lenalidomide
What this could lead to
If it works, this could point toward a new treatment option for Kaposi sarcoma in people with HIV.
What could go wrong
This was a very small, early-phase trial that was terminated early, so results are limited. Lenalidomide can cause serious side effects like low blood counts and blood clots.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

12 people

The number who actually took part.

Start date

Oct 2011

Finished

Feb 2014

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Kaposi's sarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV infection associated Kaposi disease

Contacts and locations

Locations

  • Valerie Martinez

    Clamart, France, 92141, France