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

Not Applicable

Not yet recruiting

• Conditions: Central Nervous System Leukemia; Allogeneic Hematopoietic Stem Cell Transplantation
• Interventions: Drug: TBF regimen; Drug: modified BuCY2 regimen

• Registration Number: NCT05667402
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-27
• Study First Submitted QC: 2022-12-26
• Last Update Submitted: 2022-12-26
• Study First Posted: 2022-12-28
• Last Update Posted: 2022-12-28
• Study Start: 2023-01-15
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TBF group	TBF regimen	The subjects receive TBF conditioning regimen.
Modified BuCY2 group	modified BuCY2 regimen	The subjects receive modified BuCY2 conditioning regimen.

Primary Outcome Measures

Name	Time	Method
Recurrence rate of central nervous system (CNS) leukemia	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.	The proportion of patients with recurrent central nervous system leukemia in the total enrolled population

Secondary Outcome Measures

Name	Time	Method
Hematopoietic implantation rate	From date of the treatment with the conditioning regimen until hematopoietic implantation, assessed up to 100 days..	Hematopoiesis was achieved within 100 days after allo-HSCT
PFS	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.	progression-free survival
NRM	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.	non-recurrence mortality
OS	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.	overall survival
AEs	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.	adverse effects

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China