The goal of this clinical trial is to compare Chi-BEAM With BEAM Regimen Combined With ASCT for the Treatment of ND PTCL. The main question it aims to answer are: •Whether Chi-BEAM improves patient survival compared to BEAM group Participants will be given BEAM or Chi-BEAM before ASCT. Researchers will compare the efficacy and safety of the two groups.
This is a prospective, multicenter, randomized controlled, open trial. The primary endpoint was 2-year PFS The secondary endpoint was: 2-year overall survival (OS). CR rate at 3 months post-transplant evaluation Hematopoietic reconstitution time Non-recurrent mortality (NRM)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
104
Chidemide,carmustine, etoposide, cytarabine, and melphalan
carmustine, etoposide, cytarabine, and melphalan
Hematological Department, People's Hospital of Jiangsu Province
Nanjing, Jiangsu, China
RECRUITING2-y PFS
2-year PFS
Time frame: 2 years
2-year OS
Time frame: 2 years
CR rate at 3 months post-transplant evalutation
Time frame: 2 years
hematopoietic reconstitution time
Time frame: 2 years
Non-recurrent mortality
Time frame: 2 years
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