A Safety and Efficacy Trial of a Combination of Bendamustine, Rituximab and Lenalidomide in Patients With Chronic Lymphocytic Leukemia (CLL2P)
This is a prospective, multicenter, open label, non-randomized, phase I/II-study to define safety and efficacy of BRL combination in relapsed/refractory patients and to recommend a safe and efficacious dose for future phase II/III study.
Hypothesis: The simultaneous administration of BRL in relapsed CLL is feasible, safe and efficient.
|Chronic Lymphocytic Leukemia||Drug: Bendamustine, Rituximab, Lenalidomide||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A phaseI/II Safety and Efficacy Trial of a Combination of Bendamustine, Rituximab and Lenalidomide (BRL) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia|
- dose limiting toxicity [ Time Frame: After 28 days of dosing at the respective target dose level of lenalidomide ]
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
- Response rate [ Time Frame: up to 4 years ]response will be evaluated according to criteria of the CLL-Guidelines on CLL of the IWCLL-working Group.
- progression free survival [ Time Frame: up to 4 years ]
Progression-free survival based on investigator's assessment:
PFS is defined as the time from registration to the first occurrence of progression, relapse or death from any cause. Disease progression will be assessed by the investigators using the IWCLL criteria.
- Overall Survival [ Time Frame: up to 4 years ]Overall survival is defined as the time from registration to death.
|Study Start Date:||February 2011|
|Study Completion Date:||June 2015|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: Bendamustine, Rituximab,Lenalidomide
Dose modification treatment plan of lenalidomide
Drug: Bendamustine, Rituximab, Lenalidomide
Bendamustine: 50 mg/m2, i.v., day 1+2 Rituximab: Cycle 1: 375 mg/m2, i.v. day 0; Cycle 2-6: 500mg/m2, i.v., day 1
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558167
|University Hospital of Cologne|
|Cologne, Germany, 50924|
|Study Chair:||Michael Hallek, Prof.Dr.||German CLL Study Group|
|Study Director:||Clemens Wendtner, Prof.Dr.||German CLL Study Group|