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

Phase 2 Completed 16 enrolled German CLL Study Group Genzyme, a Sanofi Company · collab University of Cologne · collab

NaSingle-groupOpen-labelTreatment

Summary

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

Timeline

Start: 2010-06
Primary completion: 2014-05
Completion: 2014-05

Publications

Results Pflug N, Cramer P, Robrecht S, Bahlo J, Westermann A, Fink AM, Schrader A, Mayer P, Oberbeck S, Seiler T, Zenz T, Durig J, Kreuzer KA, Stilgenbauer S, Eichhorst B, Hallek M, Herling M, Hopfinger G. New lessons learned in T-PLL: results from a prospective phase-II trial with fludarabine-mitoxantrone-cyclophosphamide-alemtuzumab induction followed by alemtuzumab maintenance. Leuk Lymphoma. 2019 Mar;60(3):649-657. doi: 10.1080/10428194.2018.1488253. Epub 2018 Sep 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alemtuzumab	Monoclonal antibody	10 mg	Subcutaneous
Subject	Alemtuzumab	Monoclonal antibody	30 mg	Subcutaneous
Subject	Cyclophosphamide	Other / unclassified	200 mg/m2	Intravenous
Subject	Fludarabine	Small molecule	20 mg/m2	Intravenous
Subject	Mitoxantrone	Small molecule	6 mg/m2	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications