Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Allogeneic Hematopoietic Stem Cell Transplantation | — | UNRESOLVED | — |
| Central Nervous System Leukemia | Central Nervous System Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| modified BuCY2 regimen | Drug | — | UNRESOLVED |
| TBF regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TBF group
- description
- The subjects receive TBF conditioning regimen.
- interventionNames
- Drug: TBF regimen
- type
- ACTIVE_COMPARATOR
- label
- Modified BuCY2 group
- description
- The subjects receive modified BuCY2 conditioning regimen.
- interventionNames
- Drug: modified BuCY2 regimen
Primary outcomes (1)
- measure
- Recurrence rate of central nervous system (CNS) leukemia
- timeFrame
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available