Sprung-Navigation
| 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 |