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NCT05667402
Clinical Study of TBF Regimen in Allo-HSCT in Patients With CNS Leukemia
Conditions: Central Nervous System Leukemia, Allogeneic Hematopoietic Stem Cell Transplantation
Sex: All
Ages: 14 Years – 60 Years
Phase: NA
Enrollment: 50
Sponsor: First Affiliated Hospital Xi'an Jiaotong University
Location: China
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT05667402). StuddyBuddy aggregates publicly available trial information.