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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 NCT01186640 |
| Participating Countries | Germany |
| Recruitment Status | completed |
| Contact | DCLLSG Office: Tel. +49 (0) 221-478-88220 |
| Design | Prospective, open-label, multicentre, 1-arm phase II trial |
| 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. |
| Patients recruited | 18 patients |
| Time schedule | Recruitment period: 11 June 2010 - 09 Sept 2013 End of study: July 2014 Clinical Study Report / Publication: Oct 2015 End of archiving period: July 2024 |
| Sponsor | University of Cologne |
| Coordinating Investigator | Prof. Dr. Michael Hallek, Cologne University Hospital |
| Publications | Pflug N, Cramer P, Robrecht S, Bahlo J, Westermann A, Fink AM, Schrader A, Mayer P, Oberbeck S, Seiler T, Zenz T, Dürig J, Kreuzer KA, Stilgenbauer S, Eichhorst B, Hallek M, Herling M, Hopfinger G New lessons learned in T-PLL: results from a prospective phase-II trial with fludarabine-mitoxantrone-cyclophosphamide-alemtuzumab induction followed by alemtuzumab maintenance Leuk Lymphoma. 2018 Sep 20:1-9 doi: 10.1080/10428194.2018.1488253. [Epub ahead of print] |