Allogeneic Hematopoietic Stem Cell Transplantation RecipientPhase 2/3NCT07583888
VABu Conditioning in Elderly AML HSCT
A Phase 2/3 study testing VaBU in people with Allogeneic Hematopoietic Stem Cell Transplantation Recipient and Acute Myeloid Leukemia (AML), run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This is an open-label, multi-center, single-arm clinical study evaluating the efficacy and safety of the VABu conditioning regimen in elderly patients (≥60 years) with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Allogeneic Hematopoietic Stem Cell Transplantation Recipient, Acute Myeloid Leukemia (AML)
- What is being tested?
- VaBU
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 7 May 2026to 15 Aug 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years.
- Confirmed diagnosis of acute myeloid leukemia (AML) according to WHO classification, with intermediate or high-risk prognosis.
- Previous response to Venetoclax-based therapy.
- Planned to undergo allogeneic hematopoietic stem cell transplantation (HSCT).
- Donor availability: Related donor matched at least 5/10 at HLA-A, -B, -C, -DQB1, and -DRB1; OR unrelated donor matched at least 8/10 at the same loci.
- Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) score ≤ 4.
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- ECOG performance status 0-2.
- Adequate organ function as defined by: Creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 45 mL/min (Cockcroft-Gault formula or 24-hour urine collection)； AST ≤ 3.0 × ULN and ALT ≤ 3.0 × ULN； Total bilirubin ≤ 1.5 × ULN； Left ventricular ejection fraction (LVEF) > 50%； Baseline oxygen saturation > 92%； DLCO ≥ 40% and FEV1 ≥ 50%；
- Ability to understand and provide written informed consent.
Who cannot join
- Age < 60 years.
- Poor response to prior Venetoclax-based therapy.
- Unstable systemic disease (unstable angina, myocardial infarction, cerebrovascular accident within 3 months; NYHA Class III-IV heart failure; severe arrhythmia; pulmonary hypertension).
- Active uncontrolled infection or active bleeding in vital organs.
- CNS symptoms grade ≥ 2 requiring treatment.
- Major organ surgery within 6 weeks.
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- History of malignant disease other than AML within 5 years.
- History of thrombosis, embolism, or cerebral hemorrhage within 1 year.
- ECOG performance status > 2.
- HCT-CI score > 4.
- Organ failure meeting specified criteria.
- Known HIV, active HBV, or active HCV infection.
- History of autoimmune disease requiring systemic immunosuppressive therapy.
- Pregnancy, breastfeeding, or unwillingness to use effective contraception in patients of childbearing potential.
- Drug abuse or chronic alcoholism.
- Psychiatric disorder or other condition compromising informed consent or compliance.
- Any other condition making the patient unsuitable for study participation in the investigator's judgment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Xin Kong, 67781856, mumukongxin@hotmail.com
About this study
Official title: Efficacy and Safety of the VABu Conditioning Regimen in Elderly Patients With Acute Myeloid Leukemia Undergoing Hematopoietic Stem Cell Transplantation: An Open-Label, Multicenter, Single-Arm Clinical Study
This is an open-label, multi-center, single-arm clinical study evaluating the efficacy and safety of the VABu conditioning regimen in elderly patients (≥60 years) with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic stem cell transplantation (HSCT).
The VABu regimen consists of Venetoclax, Azacitidine, Semustine, Cytarabine, and Busulfan. All enrolled participants will receive the VABu regimen as conditioning therapy prior to HSCT.
The study aims to enroll 20 participants from multiple centers in China. The primary objectives are to evaluate the overall response rate, cumulative relapse rate, overall survival, graft-versus-host disease (GVHD)-free relapse-free survival (GRFS), non-relapse mortality (NRM), incidence of acute and chronic GVHD, and reactivation rates of cytomegalovirus (CMV) and Epstein-Barr virus (EBV). Safety outcomes include treatment-related toxicities, such as bone marrow suppression, infection, and organ dysfunction.
- Conditions
- Allogeneic Hematopoietic Stem Cell Transplantation Recipient, Acute Myeloid Leukemia (AML)
- Being tested
- VaBU
- Keywords
- Acute Myeloid Leukemia; Elderly; Hematopoietic Stem Cell Transplantation; Venetoclax; Busulfan; Preconditioning
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VaBUDrug
The VABu conditioning regimen is administered prior to allogeneic hematopoietic stem cell transplantation (HSCT). The regimen consists of the following drugs administered sequentially:
Venetoclax: 600 mg/m² orally once daily on days -10 to -5. Azacitidine: 75 mg/m² subcutaneously once daily on days -10 to -6. Semustine: 250 mg/m² orally once on day -10. Cytarabine: 2 g/m² intravenously once daily on day -1. Busulfan: 0.8 mg/kg intravenously every 6 hours on days -4 to -2 (total of 12 doses).
The conditioning regimen is completed before HSCT. Dose adjustments may be made based on toxicity, concomitant medications (especially CYP3A4 inhibitors), and individual patient tolerance.
| Study group | Role | What they receive |
|---|---|---|
| VaBU | Experimental | Not described Receives: Drug: VaBU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from the date of transplantation to the date of disease progression, relapse, or death from any cause, whichever occurs first. Participants who are alive without progression or relapse at the last follow-up are censored.
Measured: 1 year and 2 years post-transplantation
Secondary outcomes (10)
Overall Survival (OS)
Overall survival is defined as the time from the date of transplantation to the date of death from any cause. Participants who are alive at the last follow-up are censored.
Measured: 1 year and 2 years post-transplantation
Cumulative Incidence of Relapse (CIR)
Measured: 1 year, 2 years
Non-relapse Mortality (NRM)
Measured: Day 100, 1 year, 2 years
GVHD-free Relapse-free Survival (GRFS)
Measured: 1 year, 2 years
Incidence of Acute GVHD
Measured: Day 100, Day 180
Incidence of Chronic GVHD
Measured: 1 year, 2 years
CMV Reactivation Rate
Measured: 1 year
EBV Reactivation Rate
include EBV-related post-transplant lymphoproliferative disorder (PTLD)
Measured: 1 year
Engraftment Rate
Measured: Day 30
Safety and Tolerability (TEAEs)
Measured: Treatment period to 30 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start7 May 2026 (estimated)
- Primary completion15 Aug 2027 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Hematopoietic Stem Cell Transplantation RecipientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants receive the same VABu conditioning regimen (Venetoclax, Azacitidine, Semustine, Cytarabine and Busulfan) prior to allogeneic hematopoietic stem cell transplantation. No comparator or control group is included.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Collaborators
- Suzhou Hongci Hematology Hospital, Suzhou, China, Huai'an Second People's Hospital and the Affiliated Huai'an Hospital of Xuzhou Medical University, Shenzhen People's Hospital, Henan Cancer Hospital
- Responsible party
- Principal investigator, Huiying Qiu, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583888
- Sponsor's protocol ID
- ZSQ003
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a small investigator-initiated study (n=20) conducted in China. Due to institutional policies regarding patient privacy protection and the lack of established infrastructure for individual participant data sharing, IPD will not be made available.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the VABu Conditioning Regimen in Elderly Patients With Acute Myeloid Leukemia Undergoing Hematopoietic Stem Cell Transplantation: An Open-Label, Multicenter, Single-Arm Clinical Study
- ClinicalTrials.gov ID
- NCT07583888
- Acronym / sponsor ID
- ZSQ003
- Conditions
- Allogeneic Hematopoietic Stem Cell Transplantation Recipient, Acute Myeloid Leukemia (AML)
- Keywords
- Acute Myeloid Leukemia; Elderly; Hematopoietic Stem Cell Transplantation; Venetoclax; Busulfan; Preconditioning
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- Suzhou Hongci Hematology Hospital, Suzhou, China, Huai'an Second People's Hospital and the Affiliated Huai'an Hospital of Xuzhou Medical University, Shenzhen People's Hospital, Henan Cancer Hospital
- Study start
- 7 May 2026 (estimated)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multi-center, single-arm clinical study evaluating the efficacy and safety of the VABu conditioning regimen in elderly patients (≥60 years) with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic stem cell transplantation (HSCT).
The VABu regimen consists of Venetoclax, Azacitidine, Semustine, Cytarabine, and Busulfan. All enrolled participants will receive the VABu regimen as conditioning therapy prior to HSCT.
The study aims to enroll 20 participants from multiple centers in China. The primary objectives are to evaluate the overall response rate, cumulative relapse rate, overall survival, graft-versus-host disease (GVHD)-free relapse-free survival (GRFS), non-relapse mortality (NRM), incidence of acute and chronic GVHD, and reactivation rates of cytomegalovirus (CMV) and Epstein-Barr virus (EBV). Safety outcomes include treatment-related toxicities, such as bone marrow suppression, infection, and organ dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants receive the same VABu conditioning regimen (Venetoclax, Azacitidine, Semustine, Cytarabine and Busulfan) prior to allogeneic hematopoietic stem cell transplantation. No comparator or control group is included.
| Arm | Type | Receives |
|---|---|---|
| VaBU | Experimental | Drug: VaBU |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 60 years.
- Confirmed diagnosis of acute myeloid leukemia (AML) according to WHO classification, with intermediate or high-risk prognosis.
- Previous response to Venetoclax-based therapy.
- Planned to undergo allogeneic hematopoietic stem cell transplantation (HSCT).
- Donor availability: Related donor matched at least 5/10 at HLA-A, -B, -C, -DQB1, and -DRB1; OR unrelated donor matched at least 8/10 at the same loci.
Key exclusion criteria (17 listed)
- Age < 60 years.
- Poor response to prior Venetoclax-based therapy.
- Unstable systemic disease (unstable angina, myocardial infarction, cerebrovascular accident within 3 months; NYHA Class III-IV heart failure; severe arrhythmia; pulmonary hypertension).
- Active uncontrolled infection or active bleeding in vital organs.
- CNS symptoms grade ≥ 2 requiring treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VaBUThe VABu conditioning regimen is administered prior to allogeneic hematopoietic stem cell transplantation (HSCT). The regimen consists of the following drugs administered sequentially: Venetoclax: 600 mg/m² orally once daily on days -10 to -5. Azacitidine: 75 mg/m² subcutaneously once daily on days -10 to -6. Semustine: 250 mg/m² orally once on day -10. Cytarabine: 2 g/m² intravenously once daily on day -1. Busulfan: 0.8 mg/kg intravenously every 6 hours on days -4 to -2 (total of 12 doses). The conditioning regimen is completed before HSCT. Dose adjustments may be made based on toxicity, concomitant medications (especially CYP3A4 inhibitors), and individual patient tolerance. | Drug | VaBU |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 1 year and 2 years post-transplantation
Progression-free survival is defined as the time from the date of transplantation to the date of disease progression, relapse, or death from any cause, whichever occurs first. Participants who are alive without progression or relapse at the last follow-up are censored.
10 secondary outcomes
Overall Survival (OS)
Time frame: 1 year and 2 years post-transplantation
Cumulative Incidence of Relapse (CIR)
Time frame: 1 year, 2 years
Non-relapse Mortality (NRM)
Time frame: Day 100, 1 year, 2 years
GVHD-free Relapse-free Survival (GRFS)
Time frame: 1 year, 2 years
Incidence of Acute GVHD
Time frame: Day 100, Day 180
Incidence of Chronic GVHD
Time frame: 1 year, 2 years
CMV Reactivation Rate
Time frame: 1 year
EBV Reactivation Rate
Time frame: 1 year
Engraftment Rate
Time frame: Day 30
Safety and Tolerability (TEAEs)
Time frame: Treatment period to 30 days post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No. This is a small investigator-initiated study (n=20) conducted in China. Due to institutional policies regarding patient privacy protection and the lack of established infrastructure for individual participant data sharing, IPD will not be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing VaBU in people with Allogeneic Hematopoietic Stem Cell Transplantation Recipient and Acute Myeloid Leukemia (AML), run by The First Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huiying Qiu, M.D. (+8618151578096 ext. +8613912792913, mumukongxin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: 1 year and 2 years post-transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.