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| Title | Pivotal Study for high dose therapy and autologous stem cell transplantation in early stages of CLL |
|---|---|
| Protocol IDs | NCT00275015 |
| Participating Countries | Germany, Austria |
| Recruitment Status | closed |
| Contact | DCLLSG Office: Tel. +49 (0) 221-478-88220 |
| Design | Prospective, open-label, multicentre phase II trial |
| Primary Objective(s) | Safety and feasibility of autologous peripheral stem cell transplantation (PBSCT) of chronic lymphocytic leukemia (CLL) early during the course of the disease. |
| Secondary Objective(s) | Safety, feasibility, efficacy of Dexa-BEAM mobilization; efficacy of ex-vivo graft purging; incidence of complete clinical and molecular remissions; progression-free survival |
| Study Population | B-CLL, Binet-Stage C and B or Binet A at high risk for disease progression; max. 1 prior chemotherapy, prior chemotherapy/ies < 6 months, no Dexa-BEAM Age ≥ 18 to ≤ 60 years |
| Treatment | 1. Cytoreductive treatment: (preferentially) FC (2-4 cycles) 2. Mobilization: Dexa-BEAM + G-CSF (1-2 cycles) 3. Myeloablation: fractionated TBI (e.g. 6x2Gy) + Cyclophosphamide (2 x 60 mg/kg; d -4 to -3) 4. autologous PBSCT (d 0) |
| Patients recruited | 216 patients (169 evaluable patients) |
| Time schedule | Recruitment period: 30.01.1997 - 12.09.2002 End of study: April 2007 Clinical Study Report / Publication: May 2012 End of archiving period: April 2022 |
| Sponsor | DCLLSG/Heidelberg/Dreger |
| Principal investigator(s) | Prof. Dr. P. Dreger, University of Heidelberg Prof. Dr. Schmitz, University of Kiel |
| Publications | Dreger P, Döhner H, McClanahan F, Busch R, Ritgen M, Greinix H, Fink AM, Knauf W, Stadler M, Pfreundschuh M, Dührsen U, Brittinger G, Hensel M, Schetelig J, Winkler D, Bühler A, Kneba M, Schmitz N, Hallek M, Stilgenbauer S Early autologous stem cell transplantation for chronic lymphocytic leukemia: long-term follow-up of the GCLLSG CLL3 trial Blood. 2012 May 24;119(21):4851-4859 |