NCT07762508Not yet recruiting
A Study of VABu Conditioning Regimen in Allo-HSCT for AML Patients
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)
Source: ClinicalTrials.gov · Last updated 19 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 8 Aug 2026
- Start date
- Aug 2026
- Primary completion date
- Jul 2029
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT07762508
What you commit to
- Study type: Interventional
- Planned participants: 42
- From Aug 2026 to the primary completion date, Jul 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Currently participating in or planning to participate in any other clinical study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.