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) |
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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 |
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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 |