Trials / Unknown
UnknownNCT05667402
Clinical Study of TBF Regimen in Allo-HSCT in Patients With CNS Leukemia
Clinical Study of TBF Regimen in Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Central Nervous System Leukemia
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
- Sex
- All
- Age
- 14 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TBF regimen | The subjects receive TBF conditioning regimen (Thiotepa, Busulfan, Fludarabine) before allo-HSCT. |
| DRUG | modified BuCY2 regimen | The subjects receive modified BuCY2 conditioning regimen (Busulfan, Cytarabine, ATG, Cyclophosphamide, CCNU) before allo-HSCT. |
Timeline
- Start date
- 2023-01-15
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
- First posted
- 2022-12-28
- Last updated
- 2022-12-28
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05667402. Inclusion in this directory is not an endorsement.