A Phase 2 interventional study of Lenalidomide in Refractory Primary-cutaneous Large B-cell Lymphoma (Leg-type), sponsored by University Hospital, Bordeaux. Completed at 24 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by University Hospital, Bordeaux · Phase 2, Interventional, and Treatment
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.
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.
University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
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Relapse after initial complete response (CR) after R-polychemotherapy Or Partial response or stable disease after R-polychemotherapy
Exclusion Criteria:
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)
Drug: Lenalidomide
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
Overall response rate (complete response CR and partial response PR) at 6 months
Response will be assessed according to clinical and isotopic criteria.
Time frame: 6 months after study treatment start
Overall response rate (complete response CR and partial response PR) at 12 months
Response will be assessed according to clinical and isotopic criteria.
Time frame: 12 months after study treatment start
Duration of response
Time between the first PR and progression
Time frame: Every 6 months
Progression-free survival
Time between the beginning of the treatment by lenalidomide and progression or death
Time frame: Every 6 months
Overall survival and disease specific survival
Time frame: Evrey 6 months
Safety : description of adverse events occured including grade based on CTCAE v4.0
Time frame: Monthly during treatment duration (up to 12 months)
Quality of life
Time frame: Every 2 months during treatment duration (up to 12 month)
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux