Adding venetoclax before stem cell transplant for high-risk leukemia and MDS
Tests adding venetoclax to chemotherapy before stem cell transplant in people with high-risk leukemia.
Plain-language title generated from the registry record
Registry title: Venetoclax-Enhanced BUCY vs. Standard BUCY Conditioning in High-Risk AML and MDS Patients Undergoing Allo-HSCT (Ven-BUCY Study)
Key facts
- Where
- Hangzhou, 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 people aged 12 to 60 with high-risk acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) who are going to have a stem cell transplant from a donor.
- Age
- 12 to 60 years
- Sex
- All sexes can join.
- Disease stage
- High-risk AML or high-risk MDS, diagnosed by 2022 WHO classification. For AML: complete remission (CR or CRi) reached before transplant. For MDS: bone marrow blasts below 20%.
- Earlier treatment
- No more than one earlier stem cell transplant. No chemotherapy (except hydroxyurea/dexamethasone) or radiotherapy in the 14 days before study treatment. BCR-ABL1, IDH or FLT3 inhibitors need at least 7 days off. No serious (grade 3 or higher) non-blood side effect from earlier venetoclax.
- Biomarker or test result
- High-risk features are required, for example a TP53 mutation, a RAS pathway mutation, KMT2A rearrangement, BCR-ABL1 fusion, or MRD positive before transplant. The record lists many other options.
Main reasons for not taking part
- Uncontrolled heart disease or NYHA class III/IV heart failure
- Known HIV infection or uncontrolled active hepatitis B or C
- Pregnant or breastfeeding women
- More than one earlier stem cell transplant
- Cannot understand the study or give informed consent
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 12 and 60 years old?
Source: NCT07183878, who can take part
Where in China
- The First Affiliated Hospital of Zhejiang University School of MedicineHangzhou, ChinaTaking people
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
- First Affiliated Hospital of Zhejiang University
- Trial code
- NCT07183878
- Record updated
- 2 September 2026
- Original description
This is a prospective, multicenter, randomized controlled trial designed to evaluate the efficacy and safety of venetoclax-enhanced BUCY (Ven-BUCY) conditioning compared to the standard BUCY regimen in patients with high-risk acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). Eligible participants aged 12 to 60 years will be randomized 1:1 to receive either Ven-BUCY or standard BUCY conditioning. The primary endpoint is relapse-free survival (RFS) at two years post-transplant. Secondary outcomes include overall survival, relapse rate, non-relapse mortality, measurable residual disease (MRD), and treatment-related adverse events. The study aims to improve post-transplant outcomes by deepening disease remission through the addition of venetoclax, a BCL-2 inhibitor known to target leukemia stem cells and enhance chemotherapy sensitivity.Read full original descriptionShow less
A Prospective, Multicenter, Randomized Controlled Study Comparing Venetoclax-Enhanced BUCY With Standard BUCY Conditioning in High-Risk AML and MDS Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
This is a prospective, multicenter, randomized controlled trial designed to evaluate the efficacy and safety of venetoclax-enhanced BUCY (Ven-BUCY) conditioning compared to the standard BUCY regimen in patients with high-risk acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). Eligible participants aged 12 to 60 years will be randomized 1:1 to receive either Ven-BUCY or standard BUCY conditioning. The primary endpoint is relapse-free survival (RFS) at two years post-transplant. Secondary outcomes include overall survival, relapse rate, non-relapse mortality, measurable residual disease (MRD), and treatment-related adverse events. The study aims to improve post-transplant outcomes by deepening disease remission through the addition of venetoclax, a BCL-2 inhibitor known to target leukemia stem cells and enhance chemotherapy sensitivity.
Inclusion: Diagnosis of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) according to 2022 WHO classification; Age between 12 and 60 years; High-risk MDS as defined by at least one of the following:; IPSS intermediate-2/high risk or IPSS-R intermediate/high/very high risk; TP53 mutation; RAS pathway mutation (e.g., NRAS, KRAS, PTPN11, CBL, NF1, RIT1, FLT3, KIT); Therapy-related MDS; High-risk AML as defined by at least one of the following:; TP53, RUNX1, or ASXL1 mutation; t(6;9)(p23;q34.1)/DEK-NUP214; KMT2A rearrangement; BCR-ABL1 fusion; inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2); -5/del(5q), -7, -17/abn(17p); Complex or monosomal karyotype; FLT3-ITD high with wild-type NPM1; Initial WBC ≥ 10×10\^9/L; Secondary AML with history of MDS/MPN or therapy-related AML; AML with specific mutations (SRSF2, SF3B1, U2AF1, ZRSR2, ASXL1, EZH2, BCOR, STAG2); MRD positive before transplantation; For AML: must have achieved CR or CRi prior to transplantation; for MDS: bone marrow blasts < 20%; Availability of a matched related or unrelated donor (10/10 or 9/10 HLA match); ECOG performance status 0-2; Creatinine clearance ≥ 60 mL/min (Cockcroft-Gault); AST/ALT ≤ 3 × ULN and total bilirubin ≤ 2 × ULN; LVEF ≥ 50% by echocardiogram; Life expectancy > 8 weeks; Willingness to use effective contraception methods during and for a specified period after the study; Signed informed consent.
Exclusion: More than one prior hematopoietic stem cell transplantation; History of grade ≥ 3 non-hematologic adverse reaction to prior venetoclax therapy; Receipt of chemotherapy (except hydroxyurea/dexamethasone) or radiotherapy within 14 days before study treatment; Ongoing use of BCR-ABL1, IDH, or FLT3 inhibitors without proper washout (≥ 7 days); Uncontrolled cardiovascular disease or New York Heart Association class III/IV heart failure; Other severe comorbid conditions that may interfere with study participation; Known HIV infection or uncontrolled active hepatitis B or C; Pregnant or breastfeeding women; Inability to understand the study protocol or provide informed consent.