A phaseI/II Safety and Efficacy Trial of a Combination of Bendamustine, Rituximab and Lenalidomid (BRL) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
As too its mechanism of action lenalidomide seems to work rather by immunomodulation than by
a direct anti-proliferative activity against CLL cells. Lenalidomide stimulates T- and
NK-cells, modulates the tumour microenvironment in CLL and inhibits bone marrow
angiogenesis. There is a rationale to combine lenalidomide with the alpha-CD20 mAb rituximab
because lenalidomide enhances NK cell mediated antibody dependent cytotoxicity of rituximab
treated NHL cells. On the other hand, there is increasing evidence that the combination of
chemotherapy (FC) and rituximab results in highest response rates and longest
progression-free survival in treatment naive and relapsed CLL. Besides FCR the combination
of bendamustine, a hybrid alkylating agent with properties of a purine-analogue, with
rituximab (BR) seems to be very active in relapsed and treatment-naive CLL based on results
of a phase II trial of the GCLLSG. Preliminary results with lenalidomide showed a promising
response rate of 32% including high risk patients. Thus, the combination of BRL could
improve the therapeutic activity in high risk CLL by combining two immunomodulatory with a
classic cytotoxic principle.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
dose limiting toxicity
DLT defined as absolute neutrophil count < 500/µl for 7 consecutive days or more febrile neutropenia platelet count < 20.000/µl grade 4 tumour flare grade 4 non-hematologic toxicity
After 28 days of dosing at the respective target dose level of lenalidomide
Yes
Michael Hallek, Prof.Dr.
Study Chair
German CLL Study Group
Germany: Federal Institute for Drugs and Medical Devices
CLL2P
NCT01558167
February 2011
June 2015
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