A Prospective Phase II Trial on R-CHOP Followed by High-dose BEAM and Autologous SCT and HLA-identical Allogenic SCT After Dose-reduced Conditioning in Patients Age < 55 Years With Primary Mantle-Cell-Lymphoma
With a median overall survival of approximately 3 years, MCL has the poorest prognosis of
all NHL entities. No potentially curative therapy has been established yet as even more
intensive therapies including high-dose chemotherapy plus autologous SCT show only moderate
improvement of the prognosis of MCL. Allogenic SCT seems to have an immunological mechanism
of action in NHL, which is commonly known as Graft-versus-Lymphoma effect. This trial´s
purpose is to improve the overall survival in patients younger than 55 years with primary
MCL by sequentially combining autologous SCT and allogenic SCT after the application of 6
courses of immunochemotherapy and high-dose chemotherapy.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy: ORR, OS, EFS
during treatment and on day 720 after allogenic SCT
Anthony D. Ho, Ph.D., Prof.
Director of Department
Germany: Federal Institute for Drugs and Medical Devices