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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Sponsor: German CLL Study Group

Current Primary Outcome: Remission Rate [ Time Frame: 2 years after trial started ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Overall Survival Time [ Time Frame: 4 years after start of trial ]

Original Secondary Outcome: Same as current

Information By: German CLL Study Group

Dates:
Date Received: August 20, 2010
Date Started: June 2010
Date Completion:
Last Updated: September 23, 2016
Last Verified: September 2016