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| 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] |