AzTrials
AzTrials

Refractory Primary-cutaneous Large B-cell Lymphoma (Leg-type)Phase 2REV-LEGNCT01556035

Lenalidomide in Relapsed or Refractory Primary-cutaneous Large B-cell Lymphoma Leg-type : Multicentre Prospective Phase II Single Arm Trial of the French Study Group of Cutaneous Lymphoma

A Phase 2 study testing Lenalidomide in people with Refractory Primary-cutaneous Large B-cell Lymphoma (Leg-type), run by University Hospital, Bordeaux at 24 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

In spite of high initial response rate after a first line treatment by R-polychemotherapy, cutaneous but also extra-cutaneous recurrences occur after 2 years in about half of the patients with PCBCL-LT. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lenalidomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
24 sitesFrance
Study dates
Jul 2012to Aug 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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.

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

France24 sites

  • CHU Amiens, Hôpital Sud

    Amiens, 80054

  • CHU Besançon, Hôpital Saint-Jacques

    Besançon, 25030

  • AP-HP Hôpital Avicenne

    Bobigny, 93009

  • AP-HP Hôpital Ambroise Paré

    Boulogne-Billancourt, 92104

  • CHU de Clermont-Ferrand, Estaing

    Clermont-Ferrand, 63003

  • AP-HP Hôpital Henri Mondor

    Créteil, 94010

  • CHU de Dijon, Le Bocage

    Dijon, 21079

  • CHU de Grenoble

    Grenoble, 38043

  • CHU de Lille Hôpital Claude Huriez

    Lille, 59037

  • Centre Léon Bérard

    Lyon, 69373

  • AP-HM Hôpital Nord

    Marseille, 13915

  • CHRU de Montpellier Hôpital Saint-Eloi

    Montpellier, 34295

  • CHU de Nantes, Hôtel Dieu

    Nantes, 44093

  • CHU de Nice Groupe hospitalier l'Archet

    Nice, 06202

  • AP-HP- Hôpital Saint Louis

    Paris, 75475

  • AP-HP Groupe hospitalier Cochin

    Paris, 75679

  • AP-HP Groupe hospitalier Bichat - Claude Bernard

    Paris, 75877

  • AP-HP Hôpital Tenon

    Paris, 75970

  • CHU de Bordeaux Hôpital du Haut Lévèque

    Pessac, 33604

  • CHU Lyon Sud

    Pierre-Bénite, 69450

  • CHU de Reims, Hôpital Robert Debré

    Reims, 51092

  • CHU de Rouen, Hôpital Charles Nicolle

    Rouen, 76031

  • CHU de Toulouse Hôpital Larrey

    Toulouse, 31059

  • CHU de Tours- Hôpital Trousseau

    Tours, 37044

Other trials in France

About this study

Official title: A Multicentre Prospective Phase II Single Arm Trial Evaluating the Benefit of Therapy With Lenalidomide (Revlimid®) in Relapsed or Refractory Primary-cutaneous Large B-cell Lymphoma (Leg-type) After First Line Treatment by Chemotherapy Plus Rituximab for the French Study Group of Cutaneous Lymphoma (GFELC)

In spite of high initial response rate after a first line treatment by R-polychemotherapy, cutaneous but also extra-cutaneous recurrences occur after 2 years in about half of the patients with PCBCL-LT. Thereafter there is no consensus concerning patients care: radiotherapy has only a palliative effect, advanced age often limits using more aggressive chemotherapies and no treatment has demonstrated a prolonged efficacy in these relapsing cases. Therefore new alternatives therapeutic options are needed. Lenalidomide has an antineoplastic pro-apoptotic effect but also immunomodulatory, and antiangiogenic properties. Preliminary results suggest its efficacy in relapsing or refractory diffuse large B-cells lymphomas, especially of nongerminal cells phenotype. By analogy with these results, lenalidomide appears as an attractive candidate in PCLBCL-LT, more specially as it has a manageable toxicity even in advanced age patients.

If the lenalidomide efficacy is confirmed in relapsing PCLBCL-LT, this will plead its evaluation as maintenance therapy after R-chemotherapy in order to avoid recurrences.

Read the detailed description

To assess benefit and safety of lenalidomide in patients with refractory or relapsing primary cutaneous large B-cell lymphoma leg type (PCBCL-LT) after a first line treatment by Rituximab and polychemotherapy. The primary endpoint is overall response rate (complete response and partial response) at 6 months. Response will be assessed according to clinical and isotopic criteria.

Optional biological study:

A biological collection (skin and blood samples) will be established. Predictive biological markers of response or of aggressiveness and resistance to the treatment will be investigated on the skin biopsies by phenotypic and genetic analyses. The recent discovery of BLIMP1 inactivation or deletion at 6q21 in activated B-cell like type of diffuse large B-cell systemic lymphoma points to the need of both a global genetic analysis by Array-CGH with Single Nucleotide Polymorphism study and a specific investigations of the status of genes such as CDKN2A, BCL2, BCL6 and BLIMP1 by FISH analysis and/or gene dosage. Xenograft will be performed from skin biopsies in order to develop animal models for PCLBCL-LT.

Lenalidomide stimulates NK cells immunity and enhances anti-tumor responses. It also seems to modify the phenotype of NK cells through a decrease of the expression of Killer cell Immunoglobulin-like Receptors and NKp46. The expression of the NK receptors on blood cells will be analyzed in order to evidence modifications of the phenotypical and functional changes under treatment, and to search for a correlation with the clinical response to the treatment.

Being tested
Lenalidomide
Keywords
oncodermatology, hematology, cutaneous B cell lymphoma, lenalidomide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenalidomideDrug

    Patient orally treated with lenalidomide 25 mg daily for 21 days with 7 days rest of a 28 days cycle.Treatment maintained for 12 months unless progression

Study groups in NCT01556035
Study groupRoleWhat they receive
Lenalidomide treatmentExperimentalNot described
Receives: Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (complete response CR and partial response PR) at 6 months

    Response will be assessed according to clinical and isotopic criteria.

    Measured: 6 months after study treatment start

Secondary outcomes (6)

  1. Overall response rate (complete response CR and partial response PR) at 12 months

    Response will be assessed according to clinical and isotopic criteria.

    Measured: 12 months after study treatment start

  2. Duration of response

    Time between the first PR and progression

    Measured: Every 6 months

  3. Progression-free survival

    Time between the beginning of the treatment by lenalidomide and progression or death

    Measured: Every 6 months

  4. Overall survival and disease specific survival

    Measured: Evrey 6 months

  5. Safety : description of adverse events occured including grade based on CTCAE v4.0

    Measured: Monthly during treatment duration (up to 12 months)

  6. Quality of life

    Measured: Every 2 months during treatment duration (up to 12 month)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionMar 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01556035
Sponsor's protocol ID
CHUBX 2011/28
Other IDs
2011-003716-23
Acronym
REV-LEG
Status last verified
Sep 2016
First submitted
12 Mar 2012
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Mareschal S, Pham-Ledard A, Viailly PJ, Dubois S, Bertrand P, Maingonnat C, Fontanilles M, Bohers E, Ruminy P, Tournier I, Courville P, Lenormand B, Duval AB, Andrieu E, Verneuil L, Vergier B, Tilly H, Joly P, Frebourg T, Beylot-Barry M, Merlio JP, Jardin F. Identification of Somatic Mutations in Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type by Massive Parallel Sequencing. J Invest Dermatol. 2017 Sep;137(9):1984-1994. doi: 10.1016/j.jid.2017.04.010. Epub 2017 May 4.

    PubMed 28479318

  • Pham-Ledard A, Cappellen D, Martinez F, Vergier B, Beylot-Barry M, Merlio JP. MYD88 somatic mutation is a genetic feature of primary cutaneous diffuse large B-cell lymphoma, leg type. J Invest Dermatol. 2012 Aug;132(8):2118-20. doi: 10.1038/jid.2012.102. Epub 2012 Apr 12. No abstract available.

    PubMed 22495176

  • Pham-Ledard A, Prochazkova-Carlotti M, Andrique L, Cappellen D, Vergier B, Martinez F, Grange F, Petrella T, Beylot-Barry M, Merlio JP. Multiple genetic alterations in primary cutaneous large B-cell lymphoma, leg type support a common lymphomagenesis with activated B-cell-like diffuse large B-cell lymphoma. Mod Pathol. 2014 Mar;27(3):402-11. doi: 10.1038/modpathol.2013.156. Epub 2013 Sep 13.

    PubMed 24030746

  • Pham-Ledard A, Beylot-Barry M, Barbe C, Leduc M, Petrella T, Vergier B, Martinez F, Cappellen D, Merlio JP, Grange F. High frequency and clinical prognostic value of MYD88 L265P mutation in primary cutaneous diffuse large B-cell lymphoma, leg-type. JAMA Dermatol. 2014 Nov;150(11):1173-9. doi: 10.1001/jamadermatol.2014.821.

    PubMed 25055137

  • Pham-Ledard A, Prochazkova-Carlotti M, Deveza M, Laforet MP, Beylot-Barry M, Vergier B, Parrens M, Feuillard J, Merlio JP, Gachard N. Molecular analysis of immunoglobulin variable genes supports a germinal center experienced normal counterpart in primary cutaneous diffuse large B-cell lymphoma, leg-type. J Dermatol Sci. 2017 Nov;88(2):238-246. doi: 10.1016/j.jdermsci.2017.07.008. Epub 2017 Jul 26.

    PubMed 28838616

  • Menguy S, Prochazkova-Carlotti M, Beylot-Barry M, Saltel F, Vergier B, Merlio JP, Pham-Ledard A. PD-L1 and PD-L2 Are Differentially Expressed by Macrophages or Tumor Cells in Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type. Am J Surg Pathol. 2018 Mar;42(3):326-334. doi: 10.1097/PAS.0000000000000983.

    PubMed 29112015

  • Beylot-Barry M, Mermin D, Maillard A, Bouabdallah R, Bonnet N, Duval-Modeste AB, Mortier L, Ingen-Housz-Oro S, Ram-Wolff C, Barete S, Dalle S, Maubec E, Quereux G, Templier I, Bagot M, Grange F, Joly P, Vergier B, Vially PJ, Gros A, Pham-Ledard A, Frison E, Merlio JP. A Single-Arm Phase II Trial of Lenalidomide in Relapsing or Refractory Primary Cutaneous Large B-Cell Lymphoma, Leg Type. J Invest Dermatol. 2018 Sep;138(9):1982-1989. doi: 10.1016/j.jid.2018.03.1516. Epub 2018 Mar 27.

    PubMed 29596904

  • Beylot-Barry M. [Cutaneous lymphomas: breakthroughs and future prospects in 2018]. Ann Dermatol Venereol. 2018 Dec;145(12S):S10-S11. doi: 10.1016/j.annder.2018.09.160. Epub 2018 Nov 1. No abstract available. French.

    PubMed 30391032

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenalidomide in people with Refractory Primary-cutaneous Large B-cell Lymphoma (Leg-type), run by University Hospital, Bordeaux at 24 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (complete response CR and partial response PR) at 6 months (time frame: 6 months after study treatment start). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01556035, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in