Venetoclax+Azacytidine+Modified BUCY Conditioning Regimen for Acute Lymphoblastic Leukemia Undergoing Allo-HSCT

• Status: Recruiting
• Trial end date: 2026-01-20
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Soochow University

Criteria

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