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NCT07183878Recruiting

Venetoclax-Enhanced BUCY vs. Standard BUCY Conditioning in High-Risk AML and MDS Patients Undergoing Allo-HSCT (Ven-BUCY Study)

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

Source: ClinicalTrials.gov · Last updated 2 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
138 (estimated)
First submitted
14 Sept 2025
Start date
20 Aug 2025
Primary completion date
20 Aug 2027
Lead sponsor
First Affiliated Hospital of Zhejiang University
NCT number
NCT07183878

What you commit to

  • Study type: Interventional
  • Planned participants: 138
  • From 20 Aug 2025 to the primary completion date, 20 Aug 2027
  • 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.

Prior treatment

  • 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)

Other illness

  • 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

Other

  • Pregnant or breastfeeding women
  • Inability to understand the study protocol or provide informed consent

Who the study is looking for

  • 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

Age in the registry: 12 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Zhejiang University School of Medicine
Coordinator of this site? Confirm its status		HangzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.