DCLLSG

CLL2M Trial

Title Multicentre phase II trial of Bendamustine in combination with rituximab for patients with previously untreated or relapsed chronic lymphocytic leukemia
CLL-2M protocol of the German CLL-Study Group (GCLLSG)
Protocol IDs EUDRACT-2005-001596-34
NCT00274989 (10 Jan 2006)
Participating Countries Germany
Status completed
Contact DCLLSG Office: Tel. +49 (0) 221-478-88220
Design Prospektive, open-label, multicentre, non-randomized phase II trial
Primary Endpoint(s) overall response rate (ORR)
Secondary Endpoint(s) - overall response rate in biological defined risk groups
- duration of response
- event-free survival
- MRD response rate
- complete response (CR) rate
- efficacy and safety
- feasibility
Study Population B-CLL in need of treatment
- Binet stage C or B, previously untreated or
- relapsed or refractory disease; at least 1, max 3 prior regimens (in case of pretreatment with bendamustine, PR ≥ 6 month)
Age ≥ 18 years
Treatment First-Line Therapy
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
q4wks; 6 cycles
2nd to 4th-Line Therapy
Bendamustine i.v. (70 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
q4wks; 6 cycles
Patients recruited First-line therapy: 117 patients
2nd - 4th-line therapy: 78 patients
Time schedule Recruitment period: 14 Mar. 2006 - 2 Sept. 2008
End of study: Aug. 2012
Clinical Study Report / Publication: Aug. 2013
End of archiving period: Dec. 2023
Sponsor University of Cologne/Faculty of Medicine
Coordinating Investigator Prof. Dr. Clemens-Martin Wendtner, München Klinik Schwabing
Publications Al-Sawaf O, Robrecht S, Bahlo J, Fink AM, Cramer P, von Tresckow J, Maurer C, Bergmann M, Seiler T, Lange E, Kneba M, Stilgenbauer S, Döhner H, Kiehl MG, Jäger U, Wendtner CM, Fischer K, Goede V, Hallek M, Eichhorst B, Hopfinger G
Impact of gender on outcome after chemoimmunotherapy in patients with chronic lymphocytic leukaemia: A meta-analysis by the german CLL study group (GCLLSG)
Leukemia. 2017 Jul 12 [Epub ahead of print]


Fischer K, Cramer P, Busch R, Böttcher S, Bahlo J, Schubert J, Pflüger KH, Schott S, Goede V, Isfort S, von Tresckow J, Fink AM, Bühler A, Winkler D, Kreuzer KA, Staib P, Ritgen M, Kneba M, Döhner H, Eichhorst BF, Hallek M, Stilgenbauer S, Wendtner CM
Bendamustine in combination with rituximab for previously untreated patients with chronic lymphocytic leukemia: a multicenter phase II trial of the German Chronic Lymphocytic Leukemia Study Group
J Clin Oncol. 2012 Sep 10;30(26):3209-16

Fischer K, Cramer P, Busch R, Stilgenbauer S, Bahlo J, Schweighofer CD, Böttcher S, Staib P, Kiehl M, Eckart MJ, Kranz G, Goede V, Elter T, Bühler A, Winkler D, Kneba M, Döhner H, Eichhorst BF, Hallek M, Wendtner CM
Bendamustine combined with rituximab in patients with relapsed and/or refractory chronic lymphocytic leukemia: a multicenter phase II trial of the german chronic lymphocytic leukemia study group
J Clin Oncol. 2011 Sep 10;29(26):3559-66