Venetoclax+Azacytidine+Modified BUCY Conditioning Regimen for Acute Myeloid Leukemia and Myelodysplastic Syndromes Undergoing Allo-HSCT

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Apr 10, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment combination for patients with high-risk acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) who are preparing for a bone marrow transplant. The treatment involves using two medications, venetoclax and azacytidine, followed by a modified conditioning regimen called BUCY, which includes busulfan and cyclophosphamide. The goal is to see how effective and safe this approach is for patients who may not have many other treatment options.

To join this study, participants must be between 8 and 65 years old and have either high-risk MDS or AML. They should need a bone marrow transplant and be able to provide informed consent. However, those who have uncontrolled infections, are pregnant or nursing, or have certain severe health issues may not qualify. Participants can expect to be closely monitored throughout the trial, and their safety and the effectiveness of the treatment will be evaluated. This study is currently recruiting participants, and it offers a potential new path for those facing these challenging conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 8 to 65 years;
• • 2. Diseases must be MDS and AML; high-risk MDS: int-2 risk, high risk by the IPSS; IPSS-R int-risk (\> 3.5 points), high risk, very high risk; high risk,very high risk by the WPSS; high-risk or relapsed/refractory AML: (1) age≥60 years; (2) High white blood cell count at first diagnosis (WBC≥100\*10\^9/L); (3) secondary AML (previous history of MDS, myeloproliferative disease, or treatment-related AML, etc.); (4) Complicated with extramedullary leukemia, such as central nervous system leukemia, granulocytic sarcoma, hepatosenomegaly; （5）high risk factors and relapsed/refractory AML（reference 2022-AML-ELN guideline）（6）not in remission or ≥CR2 before transplantation;
• • 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 \<8 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.