A new pre-transplant drug combination for acute myeloid leukemia in frailer patients
Tests venetoclax, azacitidine and busulfan before stem cell transplant in adults with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: A Study of VABu Conditioning Regimen in Allo-HSCT for AML Patients
Key facts
- Where
- Suzhou, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07762508, who can take part
Where in China
- First Affiliated Hospital of Soochow UniversitySuzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The First Affiliated Hospital of Soochow University
- Trial code
- NCT07762508
- Record updated
- 19 August 2026
- Original description
This study evaluates the effectiveness and safety of a new conditioning regimen called VABu before stem cell transplantation in patients with acute myeloid leukemia (AML) who are in their first complete remission (CR1), classified as non-high-risk per ELN 2022 guidelines, but have poor physical condition (ECOG performance status ≥ 2) or high comorbidity burden (HCT-CI ≥ 2). VABu combines venetoclax, azacitidine (or decitabine as an alternative), and busulfan. This is a single-arm, prospective study with 42 participants. All participants will receive the VABu regimen followed by stem cell transplantation. The primary outcome measure is 2-year overall survival (OS). Secondary outcomes include 2-year relapse-free survival (RFS), transplant-related mortality (TRM), engraftment failure rate, bloodstream infection (BSI), and 2-year all-cause mortality and non-relapse mortality (NRM). The study is conducted at the First Affiliated Hospital of Soochow University.Read full original descriptionShow less
A Single-Arm, Prospective Clinical Study of the Efficacy and Safety of VABu Conditioning Regimen in Allogeneic Hematopoietic Stem Cell Transplantation for Non-High-Risk AML Patients in CR1 With Low Performance Status (ECOG ≥ 2) or High Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI ≥ 2)
This study evaluates the effectiveness and safety of a new conditioning regimen called VABu before stem cell transplantation in patients with acute myeloid leukemia (AML) who are in their first complete remission (CR1), classified as non-high-risk per ELN 2022 guidelines, but have poor physical condition (ECOG performance status ≥ 2) or high comorbidity burden (HCT-CI ≥ 2). VABu combines venetoclax, azacitidine (or decitabine as an alternative), and busulfan. This is a single-arm, prospective study with 42 participants. All participants will receive the VABu regimen followed by stem cell transplantation. The primary outcome measure is 2-year overall survival (OS). Secondary outcomes include 2-year relapse-free survival (RFS), transplant-related mortality (TRM), engraftment failure rate, bloodstream infection (BSI), and 2-year all-cause mortality and non-relapse mortality (NRM). The study is conducted at the First Affiliated Hospital of Soochow University.
Inclusion: Age 18 to 70 years; Diagnosis of acute myeloid leukemia (AML) other than acute promyelocytic leukemia (APL), with first complete remission (CR1) achieved after induction chemotherapy; Classified as non-high-risk per ELN 2022 risk stratification guidelines; ECOG performance status ≥ 2 (not due to leukemia) OR Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) ≥ 2; Willing to undergo allogeneic hematopoietic stem cell transplantation and has a suitable donor; Voluntarily signs informed consent form after full understanding of the study.
Exclusion: Allergy to any component of the study drugs; Psychiatric or psychological disorders that prevent cooperation with treatment; Uncontrolled systemic or local severe infection; Severe dysfunction of major organs (heart, lung, liver, kidney) that, in the investigator's opinion, makes the patient unsuitable for enrollment; Any other conditions that, in the investigator's opinion, make the patient unsuitable for enrollment; Currently participating in or planning to participate in any other clinical study.