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New treatment option for Acute Myeloid Leukemia
Official title Venetoclax-Enhanced BUCY vs. Standard BUCY Conditioning in High-Risk AML and MDS Patients Undergoing Allo-HSCT (Ven-BUCY Study)
ClinicalTrials.gov ID: NCT07183878
What this study is testing
What is Venetoclax?
Venetoclax is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as ABT-199, Venclexta.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 60
You may be able to join if
- 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
You likely can't join if
- 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
- More than one prior hematopoietic stem cell transplantation
- Inability to understand the study protocol or provide informed consent
See the full eligibility criteria
- 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
- 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
- More than one prior hematopoietic stem cell transplantation
- Inability to understand the study protocol or provide informed consent
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.