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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05667402
Other study ID # XJTU1AF2022LSK-307
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 15, 2023
Est. completion date December 31, 2025

Study information

Verified date October 2022
Source First Affiliated Hospital Xi'an Jiaotong University
Contact Pengcheng He, MD
Phone 0086-85324035
Email hepc@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 14 Years to 60 Years
Eligibility Inclusion Criteria: - Patients diagnosed with central nervous system leukemia by MICM meet one of the following conditions: corresponding symptoms and signs of central nervous system involvement; cerebrospinal fluid pressure increased by 200 mm water column; the white blood cell count in cerebrospinal fluid was 0.01×10^9/L; cerebrospinal fluid protein qualitative test was positive or protein quantification was 45 mg/dL; leukemic cells can be found in the cerebrospinal fluid; cranial imaging suggested central involvement. - Aged 14-60 years, male or female. - KPS score: =80. - Signed the informed consent. Exclusion Criteria: - Patients intending to receive autologous hematopoietic stem cell transplantation. - Patients with transplantation contraindications. - Those who refuse to sign the informed consent form.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recurrence rate of central nervous system (CNS) leukemia The proportion of patients with recurrent central nervous system leukemia in the total enrolled population 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 Hematopoietic implantation rate Hematopoiesis was achieved within 100 days after allo-HSCT From date of the treatment with the conditioning regimen until hematopoietic implantation, assessed up to 100 days..
Secondary NRM non-recurrence mortality 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.
Secondary OS overall survival 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.
Secondary PFS progression-free survival 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.
Secondary AEs adverse effects 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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