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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TBF group | Experimental | The subjects receive TBF conditioning regimen. |
|
| Modified BuCY2 group | Active Comparator | The subjects receive modified BuCY2 conditioning regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TBF regimen | Drug | The subjects receive TBF conditioning regimen (Thiotepa, Busulfan, Fludarabine) before allo-HSCT. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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.. |
| NRM |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pengcheng He, MD | Contact | 0086-85324035 | hepc@163.com | |
| Xiaoyan Zheng, MD | Contact | 0086-15829370502 | xiaoy_2008@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Pengcheng He, MD | First Affiliated Hospital of Xian Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | 710061 | China |
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| modified BuCY2 regimen | Drug | The subjects receive modified BuCY2 conditioning regimen (Busulfan, Cytarabine, ATG, Cyclophosphamide, CCNU) before allo-HSCT. |
|
|
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. |
| 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. |
| 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. |
| 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. |