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)
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate (complete response CR and partial response PR) at 6 months
Response will be assessed according to clinical and isotopic criteria.
6 months after study treatment start
Yes
Adelaïde DOUSSAU, MD
Study Chair
University Hospital Bordeaux, USMR
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
CHUBX 2011/28
NCT01556035
July 2012
July 2015
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