Phase II Trial of Combined Immunochemotherapy With Fludarabine, Mitoxantrone, Cyclophosphamide and Alemtuzumab (FMC-Alemtuzumab) in Patients With Previously Treated or Untreated T-Prolymphocytic Leukemia
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
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
2 years after trial started