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

Allogeneic Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:

Clinical Study of TBF Regimen in Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Central Nervous System Leukemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05667402
• Other study ID #: XJTU1AF2022LSK-307
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Allogeneic Hematopoietic Stem Cell Transplantation
• Central Nervous System Leukemia
• Leukemia

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.