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| Title | Phase II Trial of Combined Immunochemotherapy with Fludarabine, Mitoxantrone, Cyclophosphamide and Alemtuzumab (FMC-Alemtuzumab) in Patients with Previously Treated or Untreated T-Prolymphocytic Leukemia |
|---|---|
| Protocol IDs | EudraCT 2008-001421-34 |
| Participating Countries | Germany, Austria (projected) |
| Recruitment Status | active |
| Design | Prospective, open-label, multicentre, 1-arm phase II trial |
| Objectives | Assessment of the feasibility, safety and efficacy of simultaneous FMC-Alemtuzumab administration followed by Alemtuzumab-maintenance therapy in patients with T-PLL |
| Primary Endpoint(s) | • Remission rate • Number of serious adverse events • Number of life-threatening infections |
| Secondary Endpoint(s) | • Overall survival time • Progression-free survival time • Duration of remission |
| Study Population | T-PLL according to WHO criteria • untreated or • pretreated patients (max. 1 previous treatment) Age ≥ 18 years |
| Treatment | I. Chemoimmunotherapy A-FMC Alemtuzumab: Cycle 1+2: 10 mg s.c., d 1-3 Cycle 3+4: CR: 10 mg s.c., d 1-3 ; PR/SD: 30 mg s.c., d 1-3 Fludarabine: 20 mg/m2 i.v., d 1-3 Mitoxantrone: 6 mg/m2 i.v., d1 Cyclophosphamide: 200 mg/m2 i.v., d 1-3 Repeat day 29, maximum 4 cycles. II. Maintenance-treatment: Alemtuzumab Alemtuzumab: 30mg s.c. The maintenance therapy will start one month after the Final Staging and will be administered monthly during the first six months plus once in month 10 and 13. |
| Targeted Accrual | 16 patients |
| Time schedule | Start of recruitment: June 2010 End of recruitment: June 2012 End of study: December 2015 |
| Protocol Version | 06.07.2010 Protocol (v. 3.1) Amendment 1 08.11.2011 Protocol (v. 3.2) Amendment 1 |
| Sponsor | University of Cologne (Sponsor number: Uni-Köln-795) |
| Coordinating Investigator | Prof. Dr. Michael Hallek, Cologne University Hospital |
| Contact for public queries | German CLL Study Group (GCLLSG) |
| Contact for scientific queries | Dr. Georg Hopfinger, Hanusch Hospital, Vienna |
| Documents (publicly available) |
Synopsis Flowchart |
| Documents (password protected) |
Protocol, Registration Forms, Diagnostic Forms, see Download Center |