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| Title | A phase I/II safety and efficacy trial of a combination of bendamustine, rituximab and lenalidomide (BRL) in patients with relapsed or refractory chronic lymphocytic leukemia |
|---|---|
| Protocol IDs | EUDRACT-2009-012957-39 |
| Recruitment Status | active |
| Design | Prospektive, open-label, multicentre, non-randomized phase I/II trial |
| Primary Endpoint(s) | Phase I: - dose-limiting toxicity (DLT) and - maximal tolerable dose (MTD) of BRL Phase II: - 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, relapsed or refractory - Binet C or A/B with active disease - CIRS score ≤ 6, WHO performance status 0-2 - relapsed or refractory disease; at least 1, max 3 prior regimens (in case of pretreatment with bendamustine: PR ≥ 6 month) Age ≥ 18 years |
| Treatment | 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 |
| Targeted Accrual | max. 34 eligible patients |
| Time schedule | Study start: 03/2011 Recruitment period: 2 years End of study: 2 years after end of treatment of last patient |
| Protocol Version | 12 January 2011 Protocol (V 2.0) |
| Sponsor | University of Cologne |
| Coordinating Investigator | Prof. Dr. Clemens-Martin Wendtner, Internal Medicine I, University Hospital of Cologne |
| Contact for public queries | German CLL Study Group (GCLLSG) |
| Contact for scientific queries | Prof. Dr. Clemens-Martin Wendtner, Internal Medicine I, University Hospital of Cologne Dr. Kirsten Fischer, GCLLSG |
| Documents (publicly available) |
Synopsis Flowchart |
| Documents (password protected) |
Protocol, Diagnostic Forms see Download Center |