CLL2G Trial

Title CHOP plus Rituximab (CHOP-R) in fludarabine refractory chronic lymphocytic leukemia (CLL) or CLL with autoimmune haemolytic anemia (AIHA) or Richter’s transformation (RT)
Protocol IDs NCT00309881 (29 Mar 2006)
Participating Countries Germany
Status completed
Contact DCLLSG Office: Tel. +49 (0) 221-478-88220
Design Prospective, open-label, multicentre, phase II trial
Primary Endpoint(s) Rate of remission, quality of remission
Secondary Endpoint(s) Rate of toxicity, progression-free survival, overall survival
Study Population B-CLL, Binet-Stage C or B with need for treatment,
F-refractory or
B-CLL with autoimmune haemolytic anemia (AIHA) or
Richter’s transformation (RT)
≤ 4 prior chemotherapy regimens
Age  ≥ 18 years
Treatment CHOP-R
Cyclophosphamide (750 mg/m², d1) +
Adriamycin (50 mg/m², d1) +
Vincristin (1,4 mg/m² (max 2mg abs.), d1) +
Prednisolone (100 mg/m²/d, d1-5)
q21d, max. 6 (8)cycles
Rituximab (375 mg/m², d0 starting from the 2nd cycle CHOP + 1x after the 6th (8th) CHOP-cycle, d21)
q21d, max 6 (8) cycles
Patients recruited 62 patients
Time schedule Recruitment period: 24 June 2003 - 31 July 2008
End of study: Mar. 2011
Clinical Study Report / Publication: Dec. 2014
End of archiving period: Mar. 2021
Sponsor University of Cologne (DCLLSG)
Coordinating Investigator Prof. Dr. M. Hallek, Internal Medicine I, University Hospital of Cologne
Publications Langerbeins P, Busch R, Anheier N, Dürig J, Bergmann M, Goebeler ME, Hurtz HJ, Stauch MB, Stilgenbauer S, Döhner H, Fink AM, Cramer P, Fischer K, Wendtner CM, Hallek M, Eichhorst B
Poor efficacy and tolerability of R-CHOP in relapsed/refractory chronic lymphocytic leukemia and Richter transformation
Am J Hematol. 2014 Dec;89(12):E239-43