Central nervous system (CNS) leukemia is a poor prognostic factor for allogeneic hematopoietic stem cell transplantation (allo-HSCT). Thiotepa can penetrate the blood-brain barrier and has immunosuppressive effects and similar effects to irradiation in allo-HSCT. This project aims to investigate whether the TBF regimen is superior to the traditional modified BuCY2 regimen to improve the long-term survival of the CNS leukemia patients.
Central nervous system (CNS) leukemia is a common extramedullary leukemia and a poor prognostic factor for allogeneic hematopoietic stem cell transplantation (allo-HSCT). There is a blood-brain barrier (BBB) in the CNS. The treatment effect of CNS leukemia is seriously limited by the low penetration of conventional chemotherapy drugs into cerebrospinal fluid. Thiotepa can penetrate the BBB and has immunosuppressive effect and myeloablative effect similar to irradiation in transplantation. Therefore, it is speculated that cestipide has certain advantages as a conditioning regimen in transplantation for CNS leukemia. This project aims to investigate whether the TBF regimen is superior to the traditional modified BuCY2 regimen to improve the long-term survival of the CNS leukemia patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
The subjects receive TBF conditioning regimen (Thiotepa, Busulfan, Fludarabine) before allo-HSCT.
The subjects receive modified BuCY2 conditioning regimen (Busulfan, Cytarabine, ATG, Cyclophosphamide, CCNU) before allo-HSCT.
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Recurrence rate of central nervous system (CNS) leukemia
The proportion of patients with recurrent central nervous system leukemia in the total enrolled population
Time frame: From date of the treatment with the conditioning regimen until CNS leukemia relapse, the end of follow-up or the date of death from any cause, whichever came first, assessed up to 36 months.
Hematopoietic implantation rate
Hematopoiesis was achieved within 100 days after allo-HSCT
Time frame: From date of the treatment with the conditioning regimen until hematopoietic implantation, assessed up to 100 days..
NRM
non-recurrence mortality
Time frame: From date of allo-HSCT until the date of death from any cause or the end of follow-up, whichever came first, assessed up to 36 months.
OS
overall survival
Time frame: From date of the treatment with the conditioning regimen until the end of follow-up or the date of death from any cause, whichever came first, assessed up to 36 months.
PFS
progression-free survival
Time frame: From date of the treatment with the conditioning regimen until leukemia progression, the end of follow-up or the date of death from any cause, whichever came first, assessed up to 36 months.
AEs
adverse effects
Time frame: From date of the treatment with the conditioning regimen until the occurrence of adverse effects, the end of follow-up or the date of death from any cause, whichever came first, assessed up to 36 months.
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