DCLLSG

CLL2P Trial

Title A phase I/II safety and efficacy trial of a combination of bendamustine, rituximab and lenalidomide (BRL) with relapsed or refractory chronic lymphocytic leukemia (CLL) and a phase II efficacy trial for patients with previously untreated CLL
Protocol IDs EUDRACT-2009-012957-39
NCT01558167
Status Completed; Prematurely terminated
Participating Countries Germany
Design Prospektive, open-label, multicentre, non-randomized phase I/II trial
Primary Endpoint(s) Phase I for patients with relapsed/refractory CLL:
- dose-limiting toxicity (DLT) and
- maximal tolerable dose (MTD) of BRL
Phase II for relapsed/refractory CLL and previously untreated CLL:
- overall response rate (ORR)
Secondary Endpoint(s) - Response rate (including molecular responses)
- Safety assessment
- Progression-free survival
- Overall survival
Study Population B-CLL according to the updated IWCLL guidelines (Hallek et al. 2008) in need of treatment
- Binet C or A/B with active disease
- CIRS score ≤ 6, WHO performance status 0-2
• Previously untreated patients or
• Patients with relapsed or refractory CLL with max 3 prior regimens (in case of pretreatment with bendamustine: PR ≥ 6 month)
Age ≥ 18 years
Treatment Relapsed/refractory CLL:
Bendamustine i.v. (50 mg/m²/d, d1-2) cycle 1-6
Rituximab i.v. (375 mg/m²/d, d0) cycle 1
Rituximab i.v. (500 mg/m²/d, d1) cycle 2-6
Lenalidomide p.o. (intra-individual and inter-individual dose escalation: 2,5/5/10/15mg/MTD, d1 - d28)
q4wks; 6 cycles

Previously untreated CLL:
Bendamustine i.v. (90 mg/m²/d, d1-2) cycle 1-6
Rituximab i.v. (375 mg/m²/d, d0) cycle 1
Rituximab i.v. (500 mg/m²/d, d1) cycle 2-6
Lenalidomide p.o. (intra-individual dose escalation):5mg cycle 1, 10mg cycle 2, 15mg cycle 3-6
Patients recruited 22 patients
Time schedule Recruitment period: 06.04.2011 - 28.06.2013
End of study: June 2015
Clinical Study Report / Publication: Feb 2016
End of archiving period: Mar 2025
Sponsor University of Cologne
Coordinating Investigator Prof. Dr. Clemens-Martin Wendtner, München Klinik Schwabing
Publications Maurer C, Pflug N, Bahlo J, Kluth S, Rhein C, Cramer P, Gross-Ophoff C, Langerbeins P, Fink AM, Eichhorst B, Kreuzer KA, Fischer N, Tausch E, Stilgenbauer S, Böttcher S, Döhner H, Kneba M, Dreyling M, Binder M, Hallek M, Wendtner CM, Bergmann M, Fischer K; German CLL Study Group
Bendamustine and Rituximab in Combination with Lenalidomide in Patients with Chronic Lymphocytic Leukemia
Eur J Haematol. 2015 Dec 8. doi: 10.1111/ejh.12714. [Epub ahead of print]