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T-cell Prolymphocytic Leukemia

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Mitoxantrone

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Alemtuzumab

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First treatment phase: Chemoimmunotherapy A-FMC maximum 4 cycles. Second treatment phase: Maintenance-treatment with 30mg Alemtuzumab s.c.

I. First treatment phase: Chemoimmunotherapy A-FMC

Alemtuzumab:

Cycle 1+2:

10 mg s.c., days 1-3

Cycle 3+4:

CR: 10 mg s.c., days 1-3 PR/SD: 30 mg s.c., days 1-3 Fludarabine: 20 mg/m2 i.v., days 1-3 Mitoxantrone: 6 mg/m2 i.v., day 1 Cyclophosphamide: 200 mg/m2 i.v., days 1-3 Repeat day 29, maximum 4 cycles. II. Second treatment phase: Maintenance-treatment with 30mg Alemtuzumab 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.

Fludarabine, Mitoxantrone, Cyclophosphamide and Alemtuzumab

maintenance with Alemtuzumab following a induction with combined immunochemotherapy consisting of Fludarabine, cyclophosphamide, mitoxantrone and alemtuzumab

Michael Hallek, Prof. MD

Study hypothesis: Simultaneous FMC-Alemtuzumab administration followed by Alemtuzumab maintenance therapy in patients with T-PLL is feasible, safe and efficient.

As the median survival time of patients with T-PLL is less than 12 months, the treatment of T-PLL is a special challenge.

The overall response rates with conventional chemotherapy or Deoxycoformycin were low (about 30% and 40%), with the monoclonal antibody Alemtuzumab response rates of 50% to 70% were achieved, but the duration of the response was short.

In the previous trial (T PLL 1), the efficacy of the FMC regimen (FMC = Fludarabine, Mitoxantrone and Cyclophosphamide) was tested, a preliminary analysis of 16 patients revealed a response rate of more than 60% after FMC-polychemotherapy and 83% after the subsequent administration of Alemtuzumab.

The goal of the T-PLL2-protocol is to assess if the simultaneous administration of FMC-polychemotherapy and Alemtuzumab with a subsequent Alemtuzumab maintenance therapy is capable of improving the remission rate and the disease-free survival time in patients with T-PLL.

Combined Immunochemotherapy in Patients With T-Prolymphocytic Leukemia (T-PLL)

Phase II Trial of Combined Immunochemotherapy With Fludarabine, Mitoxantrone, Cyclophosphamide and Alemtuzumab (FMC-Alemtuzumab) in Patients With Previously Treated or Untreated T-Prolymphocytic Leukemia

Efficacy of the FMC therapy and Alemtuzumab Percentage and 95%-confidence-interval of response rates (CR, CRi, nPR, PR, SD and PD) will be provided.

OS will be calculated from the patient´s time of recruitment to death from any cause.

Genzyme, a Sanofi Company

University of Cologne

German CLL Study Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Combined Immunochemotherapy in Patients With T-Prolymphocytic Leukemia (T-PLL)	NCT01186640	T-cell-prolymph...	Fludarabine, Mi... Alemtuzumab	18 Years -	German CLL Study Group
Combined Immunochemotherapy in Patients With T-Prolymphocytic Leukemia (T-PLL)	NCT01186640	T-cell-prolymph...	Fludarabine, Mi... Alemtuzumab	18 Years -	German CLL Study Group

Spots Global Cancer Trial Database for fludarabine, mitoxantrone, cyclophosphamide and alemtuzumab