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| Title | Consolidation therapy with CAMPATH-1H (alemtuzumab) in patients ≤ 65 years with chronic lymphocytic leukemia who are in complete or partial remission after initial cytoreduction with fludarabine or fludarabine plus cyclophosphamide |
|---|---|
| Protocol IDs | --- |
| Status | prematurely terminated due to severe infections in 7 of 11 patients |
| Contact | DCLLSG Office: Tel. +49 (0) 221-478-88220 |
| Design | Prospektive, open-label, multicentre, randomized phase III trial |
| Objectives | - Does consolidation therapy with CAMPATH-1H result in a prolonged
progression-free survival in comparison to patients who do not receive
further treatment? - Is it possible to eliminate (minimal) residual disease by treatment with CAMPATH-1H (to turn a PR into a CR? to turn a PCR-positive CR into a PCR-negative CR?)? - Does consolidation therapy with CAMPATH-1H translate into a survival benefit or even cure compared to patients with no further treatment? - How is the safety profile and the quality of life in patients treated with CAMPATH-1H as consolidation therapy? |
| Primary Endpoint(s) | Progression free survival (PFS) |
| Secondary Endpoint(s) | Rate of molecular/complete responses, remission duration, overall survival, side effects, quality of life, resource use assessment |
| Study Population | B-CLL, Binet-Stage C or B CR/PR after treatment with F/ FC in the CLL4 protocol of the DCLLSG Age ≥ 18 or ≤ 65 years |
| Treatment | Arm A (CAMPATH-1H): Alemtuzumab (3-30mg, 3x/week; dose escalation d1-3 of first week) max. 12 weeks + Premedication + Prophylaxis |
| Arm B: wait & watch |
|
| Patients recruited | 23 patients, 21 evaluable (Alemtuzumab: 11, w&w: 10) |
| Time schedule | recruitment period: 20.06.2001 - 05.07.2002 End of study: Sept 2002 Clinical Study Report / Publication: June 2004 End of archiving period: Sept 2012 |
| Sponsor | University of Cologne |
| Principal investigators | Prof. Dr. M. Hallek, University of Cologne Prof. Dr. B. Emmerich, University of Munich (LMU) |
| Publications | Wendtner CM, Ritgen M, Schweighofer CD, Fingerle-Rowson G, Campe H,
Jager G, Eichhorst B, Busch R, Diem H, Engert A, Stilgenbauer S, Dohner H,
Kneba M, Emmerich B, Hallek M; German CLL Study Group (GCLLSG) Consolidation with alemtuzumab in patients with chronic lymphocytic leukemia (CLL) in first remission--experience on safety and efficacy within a randomized multicenter phase III trial of the German CLL Study Group (GCLLSG) Leukemia. 2004; 18(6): 1093 - 101 |