Combined Immunochemotherapy in Patients With T-Prolymphocytic Leukemia (T-PLL)
|T-cell-prolymphocytic Leukemia||Drug: Fludarabine, Mitoxantrone, Cyclophosphamide and Alemtuzumab Drug: Alemtuzumab||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official 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|
- Remission Rate [ Time Frame: 2 years after trial started ]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.
- Overall Survival Time [ Time Frame: 4 years after start of trial ]OS will be calculated from the patient´s time of recruitment to death from any cause.
|Study Start Date:||June 2010|
|Study Completion Date:||May 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Experimental: FCM-A followed by A-maintenance
First treatment phase: Chemoimmunotherapy A-FMC maximum 4 cycles. Second treatment phase: Maintenance-treatment with 30mg Alemtuzumab s.c.
Drug: Fludarabine, Mitoxantrone, Cyclophosphamide and Alemtuzumab
I. First treatment phase: Chemoimmunotherapy A-FMC
10 mg s.c., days 1-3
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.
Other Names:Drug: Alemtuzumab
maintenance with Alemtuzumab following a induction with combined immunochemotherapy consisting of Fludarabine, cyclophosphamide, mitoxantrone and alemtuzumab
Other Name: Mabcampath
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186640
|University Hospital Cologne|
|Cologne, Germany, 50924|
|Principal Investigator:||Michael Hallek, Prof. MD||German CLL Study Group|