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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with acute myeloid leukemia (not APL) who are in first complete remission and will have a stem cell transplant from a donor. They must have poor physical condition or a high comorbidity score.
- Age
- 18 to 70 years
- Sex
- All sexes can join
- Disease stage
- Acute myeloid leukemia other than APL, in first complete remission (CR1) after induction chemotherapy, non-high-risk by ELN 2022 guidelines
- Earlier treatment
- Must have had induction chemotherapy and reached first complete remission
Main reasons for not taking part
- Allergy to any component of the study drugs
- Mental health conditions that prevent cooperation with treatment
- Uncontrolled severe infection
- Severe dysfunction of the heart, lung, liver or kidney, in the investigator's opinion
- Taking part in, or planning to join, another clinical study
Read by machine on 9 November 2026.
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.