T-cell Non-Hodgkin Lymphoma Clinical Trial
Official title:
A Phase II Study of CHOEP Induction Followed by Gemcitabine/Busulfan/Melphalan Autologous Stem Cell Transplantation for Patients With Newly Diagnosed T-Cell Lymphoma
The current standard of care for the frontline treatment of peripheral T-cell lymphomas (PTCL) is induction chemotherapy followed by autologous stem cell transplantation (ASCT). However, many patients are unable to get to ASCT or relapse after ASCT, with a poor prognosis. Recently, a novel ASCT conditioning regimen of gemcitabine, busulfan and melphalan (Gem/Bu/Mel) has been reported to lead to favorable outcomes in this disease. We therefore designed a frontline regimen of CHOEP induction followed by Gem/Bu/Mel ASCT, and report the results of a phase 2 study of this regimen in patients with PTCL.
Objectives: Primary - To estimate the proportion of patients alive and progression-free at 24 months after beginning induction therapy Secondary - To estimate the response rate (complete remission (CR) and partial remission (PR)) after CHOEP x 6 and after Gem/Bu/Mel ASCT - To estimate overall survival (OS), progression-free survival (PFS), cumulative incidence of relapse (CIR), and non-relapse mortality (NRM) - To estimate the toxicity (grade 3 and above) - To estimate the rate of successful stem cell mobilization after CHOEP in responding patients - To estimate the proportion of patients who can successfully complete the entire treatment regimen - To estimate the time to engraftment of neutrophil and platelet engraftment after ASCT - To determine whether tumor DNA can be detected in peripheral blood of patients before therapy - To evaluate the changes and prognostic relevance in detectable tumor DNA in peripheral blood after induction chemotherapy (CHOEP) and after Gem/Bu/Mel ASCT ;
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