Clinical trial · Interventional
Venetoclax+Azacytidine+Modified BUCY Conditioning Regimen for Acute Lymphoblastic Leukemia Undergoing Allo-HSCT
Venetoclax (VEN)+Azacytidine (AZA) Followed by Modified BUCY Conditioning Regimen for High Risk or Refractory/Relapsed Acute Lymphoblastic Leukemia Undergoing Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)
- 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)
The purpose of this prospective, open-label, single-center study is to evaluate the efficacy and safety of VEN-AZA (venetoclax and azacytidine) followed by modified BUCY (busulfan and cyclophosphamide) as conditioning regimen for high-risk or relapsed/refractory acute lymphoblastic leukemia (ALL) undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).
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 |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Allogeneic Hematopoietic Stem Cell Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VEN+AZA+Modified BUCY | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- VEN+AZA+Modified BUCY
- interventionNames
- Drug: VEN+AZA+Modified BUCY
Primary outcomes (2)
- measure
- disease-free survival (DFS)
- timeFrame
- 3 years after transplantation
- description
- It is measured from the time from randomization to the first of relapse or death.
- measure
- overall survival (OS)
- timeFrame
- 3 years after transplantation
- description
- It is measured from the time of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 14 to 65 years; 2. Diagnosis of high-risk or relapsed/refractory acute lymphoblastic leukemia at the time of transplant. 3. Must need a bone marrow transplant; 4. Must have the ability to observe the efficacy and events; 5. Patient must have ability to understand and willingness to provide written informed consent prior to participation in the study and any related procedures being performed. Exclusion Criteria: 1. Age \<14 or \>65 years; 2. Uncontrolled bacterial, viral, fungal, or other infection before conditioning regimen; 3. Pregnant or lactating females; 4. Current participation in another clinical trial; 5. Contra-indication to one of the drug of the regimen; 6. Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo the agents included in the conditioning regimen
References
Publications (0)
Data not yet available