Venetoclax+Azacytidine+Modified BUCY Conditioning Regimen for Acute Lymphoblastic Leukemia 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 approach for patients with high-risk or relapsed acute lymphoblastic leukemia (ALL) who need a stem cell transplant. The trial is testing a combination of two medications, venetoclax and azacytidine, followed by a modified conditioning regimen using busulfan and cyclophosphamide. The goal is to see how effective and safe this treatment is for patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT), which is a procedure where a patient receives stem cells from another person to help restore their blood cells.

To be eligible for this trial, participants should be between 14 and 65 years old and diagnosed with high-risk or relapsed ALL. They must require a bone marrow transplant and be able to understand the study details and provide consent. Unfortunately, those who have certain infections, are pregnant, or have severe health problems may not qualify. If you participate, you will receive the study treatment and be closely monitored for its effects and any side effects during your time in the trial. Your safety and well-being are the top priority throughout the study.

Gender

ALL

Eligibility 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