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

NCT05667402 | Unknown

• 1 other identifier: XJTU1AF2022LSK-307
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Nervous System Leukemia; Allogeneic Hematopoietic Stem Cell Transplantation

Outcome Measures

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

  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 (5)

• Hematopoietic implantation rate

  From date of the treatment with the conditioning regimen until hematopoietic implantation, assessed up to 100 days..

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

TBF group

EXPERIMENTAL

The subjects receive TBF conditioning regimen.

Drug: TBF regimen

Modified BuCY2 group

ACTIVE COMPARATOR

The subjects receive modified BuCY2 conditioning regimen.

Drug: modified BuCY2 regimen

Interventions

TBF regimen DRUG

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

Also known as: Conditioning treatment with TBF regimen

TBF group

modified BuCY2 regimen DRUG

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

Also known as: Conditioning treatment with modified BuCY2 regimen

Modified BuCY2 group

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients intending to receive autologous hematopoietic stem cell transplantation.
• Patients with transplantation contraindications.
• Those who refuse to sign the informed consent form.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Study Officials

• Pengcheng He, MD

  First Affiliated Hospital of Xian Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pengcheng He, MD

CONTACT

0086-85324035; hepc@163.com

Xiaoyan Zheng, MD

CONTACT

0086-15829370502; xiaoy_2008@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: December 28, 2022
• Study Start: January 15, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 28, 2022

Record last verified: 2022-10

Locations

CN (1)