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| Title | Fludarabine, Mitoxantrone and Cyclophosphamide (FMC) in T-CLL and T-PLL followed by Alemtuzumab as consolidation |
|---|---|
| Protocol IDs | NCT00278213 |
| Participating Countries | Germany, Austria |
| Status | completed |
| Contact | DCLLSG Office: Tel. +49 (0) 221-478-88220 |
| Design | Prospektive, open-label, multicentre, non-randomized phase II trial |
| Objectives | Determination of adverse event and remission quality with FMC followed by sequential Alemtuzumab |
| Primary Endpoint(s) | Number of severe adverse events, life-threating infections, remission rate |
| Secondary Endpoint(s) | Overall survival, progression free survival, remission quality |
| Study Population | T-PLL Max 2 prior therapies (excluding study medication) Age ≥ 18 (A: ≥ 19) to ≤ 65 years |
| Treatment | Induction Therapy: Fludarabine (25 mg/m2/d, d1-3) + Mitoxantrone (8 mg/m2, d1) + Cyclophosphamide (200 mg/m2/d, d1-3) q28d; 2 - 4 cycles Consolidation Therapy: Campath-1H (dose escalation 3/10/30 mg in week 1, thereafter 30mg/d, d1, 3, 5); max 12 weeks |
| Patients recruited | 25 patients |
| Time schedule | Recruitment period: 30 Nov. 2001 - 13 Feb. 2007 End of study: Dec 2009 Clinical Study Report / Publication: Mar 2013 End of archiving period: Dec 2019 |
| Sponsor | GCLLSG |
| Principal investigator | Dr. G. Hopfinger, AKH Wien (A) |
| Publications | Hopfinger G, Busch R, Pflug N, Weit N, Westermann A, Fink AM, Cramer P, Reinart N, Winkler D, Fingerle-Rowson G, Stilgenbauer S, Döhner H, Kandler G, Eichhorst B, Hallek M, Herling M Sequential chemoimmunotherapy of fludarabine, mitoxantrone, and cyclophosphamide induction followed by alemtuzumab consolidation is effective in T-cell prolymphocytic leukemia Cancer. 2013 Mar 19 doi: 10.1002/cncr.27972. [Epub ahead of print] |