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

Xi'an Jiaotong University

Status: Not yet enrolling

Conditions: Allogeneic Hematopoietic Stem Cell Transplantation; Central Nervous System Leukemia

Treatments: Drug: modified BuCY2 regimen; Drug: TBF regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT05667402

XJTU1AF2022LSK-307

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 14 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

TBF group

Experimental group

Description:

The subjects receive TBF conditioning regimen.

Treatment:

Drug: TBF regimen

Modified BuCY2 group

Active Comparator group

Description:

The subjects receive modified BuCY2 conditioning regimen.

Treatment:

Drug: modified BuCY2 regimen