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Old drug, new hope for rare skin cancer?

NCT ID NCT01556035

Disease control Sponsor: University Hospital, Bordeaux 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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested the drug lenalidomide (Revlimid) in 19 people with a rare type of skin lymphoma called leg-type large B-cell lymphoma that had come back or not responded to initial chemotherapy. Participants took lenalidomide pills daily for 21 days, then rested for 7 days, repeating this cycle for up to a year. The main goal was to see how many patients had their tumors shrink or disappear after 6 months.

What this could mean

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

Active substance
lenalidomide (Revlimid)
What this could lead to
If it works, this could offer a new treatment option for people with this rare skin lymphoma that has come back after initial therapy.
What could go wrong
This is a small, early-phase trial with only 19 participants, so results may not apply broadly. Lenalidomide can cause side effects like low blood counts and fatigue.

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

19 people

The number who actually took part.

Start date

Jul 2012

Finished

Aug 2015

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

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: * Biopsy-proven Primary cutaneous large B-cell lymphoma leg-type * Clinically measurable skin involvement (T1-T3) or skin and nodal (N1-N3) involvement measurable by PET-CT, corresponding to : Relapse after initial complete response (CR) after R-polychemotherapy Or Partial response or stable disease after R-polychemotherapy * Age \> 18 years * Life expectancy \> 3 months * WHO performance status 0-2 * Skin biopsy performed at the inclusion on a skin tumor : new tumor in case of relapsing PCLBCL-LT or initial skin tumor refractory to the previous treatment * Signed informed consent for clinical and biological analyses. The Lenalidomide Information Sheet will be given to each patient receiving lenalidomide study therapy. The patient must read this document prior to starting lenalidomide study treatment and each time they receive a new supply of study drug. * Social security cover * Conditions of global RPP have to be fulfilled by all the patients * The Lenalidomide Education and Counseling Guidance Document must be completed and signed by either a trained counselor or the Investigator at the participating clinical center prior to each dispensing of lenalidomide study treatment. A copy of this document must be maintained in the patient records. Exclusion Criteria: * Central nervous system involvement (cerebral CT scan is performed at the inclusion) * One or more of the biological abnormalities : Neutrophil count \< 1,500/mm3 ; Platelet count \< 60,000/mm3 ; Transaminases \> 5 x upper limit of normal ; Total bilirubin \> 2.0 mg/dl (34 µmol/L)/ conjugated bilirubin\>0.8 mg/dL, except of haemolytic anemia ; Creatinine clearance \< 50 mL /min ( measured or calculated according to the method of Cockcroft-Gault) * Pregnant or lactating females, potentially childbearing females defined by sexually mature female who: 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months. * Patients should not receive steroids continuously except for prednisone for tumoral flare treatment * Uncontrolled infectious and thromboembolic diseases * Subjects not willing to take deep venous thrombosis prophylaxis * Prior history of malignancies unless the subject has been free of the disease for ≥5 years. Exceptions include basal cell skin carcinoma, carcinoma in situ of the cervix or of the breast * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form * Known seropositive for or active viral infection with HIV, Hepatitis B and C virus. * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection requiring parenteral antibiotics, uncontrolled diabetes mellitus as defined by the investigator * Chronic symptomatic congestive heart failure (III or IV of the NYHA Classification for Heart Disease) * Unstable angina pectoris, angioplasty or myocardial infarctions within 6 months * Clinically significant cardiac arrhythmia that is symptomatic or requires treatment, or asymptomatic sustained ventricular tachycardia. * Prior ≥ Grade 3 allergic reaction/hypersensitivity or desquamative rash while taking thalidomide * Any standard or experimental anti-cancer drug therapy or radiation within 3 weeks of the initiation of study drug therapy. * Participation in another clinical trial

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Conditions

The condition(s) this trial relates to.

primary cutaneous diffuse large B-cell lymphoma, Leg type

As listed by the trial registrant

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

Refractory primary-cutaneous large B-cell lymphoma (leg-type)

Contacts and locations

Locations

  • AP-HM Hôpital Nord

    Marseille, 13915, France

  • AP-HP Groupe hospitalier Bichat - Claude Bernard

    Paris, 75877, France

  • AP-HP Groupe hospitalier Cochin

    Paris, 75679, France

  • AP-HP Hôpital Ambroise Paré

    Boulogne-Billancourt, 92104, France

  • AP-HP Hôpital Avicenne

    Bobigny, 93009, France

  • AP-HP Hôpital Henri Mondor

    Créteil, 94010, France

  • AP-HP Hôpital Tenon

    Paris, 75970, France

  • AP-HP- Hôpital Saint Louis

    Paris, 75475, France

  • CHRU de Montpellier Hôpital Saint-Eloi

    Montpellier, 34295, France

  • CHU Amiens, Hôpital Sud

    Amiens, 80054, France

  • CHU Besançon, Hôpital Saint-Jacques

    Besançon, 25030, France

  • CHU Lyon Sud

    Pierre-Bénite, 69450, France

  • CHU de Bordeaux Hôpital du Haut Lévèque

    Pessac, 33604, France

  • CHU de Clermont-Ferrand, Estaing

    Clermont-Ferrand, 63003, France

  • CHU de Dijon, Le Bocage

    Dijon, 21079, France

  • CHU de Grenoble

    Grenoble, 38043, France

  • CHU de Lille Hôpital Claude Huriez

    Lille, 59037, France

  • CHU de Nantes, Hôtel Dieu

    Nantes, 44093, France

  • CHU de Nice Groupe hospitalier l'Archet

    Nice, 06202, France

  • CHU de Reims, Hôpital Robert Debré

    Reims, 51092, France

  • CHU de Rouen, Hôpital Charles Nicolle

    Rouen, 76031, France

  • CHU de Toulouse Hôpital Larrey

    Toulouse, 31059, France

  • CHU de Tours- Hôpital Trousseau

    Tours, 37044, France

  • Centre Léon Bérard

    Lyon, 69373, France