Clinical Study of TBF Regimen in Allo-HSCT in Patients With CNS Leukemia

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 314 studies on the registry; 87 are open to participants now.

Study arms

• Experimental
  TBF group

  The subjects receive TBF conditioning regimen.

  Drug: TBF regimen

• Active comparator
  Modified BuCY2 group

  The subjects receive modified BuCY2 conditioning regimen.

  Drug: modified BuCY2 regimen

Interventions

• DrugTBF regimen

  The subjects receive TBF conditioning regimen (Thiotepa, Busulfan, Fludarabine) before allo-HSCT.

  Also known as: Conditioning treatment with TBF regimen

• Drugmodified BuCY2 regimen

  The subjects receive modified BuCY2 conditioning regimen (Busulfan, Cytarabine, ATG, Cyclophosphamide, CCNU) before allo-HSCT.

  Also known as: Conditioning treatment with modified BuCY2 regimen

Primary outcomes

1. 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.

Secondary outcomes

1. 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..

2. 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.

3. 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.

4. 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.

5. 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.