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
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital Xi'an Jiaotong University |
China,
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. |
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