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Die klinische Studie NCT07183878 (Ven-BUCY) für Akute myeloische Leukämie, High-Risk Acute Myeloid Leukemia, Myelodysplastische Syndrome, High-Risk Myelodysplastic Syndromes ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
Venetoclax-Enhanced BUCY vs. Standard BUCY Conditioning in High-Risk AML and MDS Patients Undergoing Allo-HSCT (Ven-BUCY Study) 138 Randomisiert Gesamtüberleben
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Die klinische Studie NCT07183878 (Ven-BUCY) ist eine interventionsstudie zur Untersuchung von Akute myeloische Leukämie, High-Risk Acute Myeloid Leukemia, Myelodysplastische Syndrome, High-Risk Myelodysplastic Syndromes und hat den Status offene rekrutierung. Die Studie startete am 20. August 2025 und soll 138 Teilnehmer aufnehmen. Durchgeführt von First Affiliated Hospital of Zhejiang University ist der Abschluss für 20. August 2028 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 19. September 2025 aktualisiert.
Kurzbeschreibung
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 rando...Mehr anzeigen
Ausführliche Beschreibung
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the only curative therapy for high-risk acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). However, post-transplant relapse remains the leading cause of treatment failure, especially among patients receiving matched sibling or unrelated donor transplants. While myeloablative conditioning (MAC) regimens like BUCY (busulfan + cyclopho...Mehr anzeigen
Offizieller Titel
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
Erkrankungen
Akute myeloische LeukämieHigh-Risk Acute Myeloid LeukemiaMyelodysplastische SyndromeHigh-Risk Myelodysplastic SyndromesWeitere Studien-IDs
- Ven-BUCY
NCT-Nummer
Studienbeginn (tatsächlich)
2025-08-20
Zuletzt aktualisiert
2025-09-19
Studienende (vorauss.)
2028-08-20
Geplante Rekrutierung
138
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
Venetoclax
BUCY conditioning
Allogeneic Hematopoietic Stem Cell Transplantation
Myeloablative Conditioning
Relapse-Free Survival
Graft-versus-Leukemia
GVHD
High-Risk AML
High-Risk MDS
BUCY conditioning
Allogeneic Hematopoietic Stem Cell Transplantation
Myeloablative Conditioning
Relapse-Free Survival
Graft-versus-Leukemia
GVHD
High-Risk AML
High-Risk MDS
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellVene-BUCY Participants in this arm will receive a venetoclax-enhanced BUCY conditioning regimen before undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). Venetoclax is administered from day -14 to -8 (400 mg/day for patients ≥14 years; 360 mg/m²/day for patients aged 12-14 years). Standard BUCY regimen includes busulfan (0.8 mg/kg every 6 hours, days -7 to -4), cyclophosphamide (60 mg/kg/day, days -3 an...Mehr anzeigen | Venetoclax Venetoclax is administered orally at 400 mg/day for participants ≥14 years or 360 mg/m²/day for those aged 12-14 years, from day -14 to -8 before allogeneic hematopoietic stem cell transplantation (allo-HSCT). Dose is adjusted to 100 mg/day (or 90 mg/m²/day for pediatric patients) if used with strong CYP3A4 inhibitors such as posaconazole. |
Aktives VergleichspräparatBUCY Participants in this arm will receive the standard BUCY myeloablative conditioning regimen prior to allo-HSCT. The regimen includes busulfan (0.8 mg/kg every 6 hours, days -7 to -4), cyclophosphamide (60 mg/kg/day, days -3 and -2), and MeCCNU (250 mg/m² on day -1). ATG may be included in cases where the donor or recipient is over 40 years old. No venetoclax is used in this arm. | None-placebo Participants in this arm will not receive venetoclax as part of their conditioning regimen. They will undergo standard myeloablative conditioning with BUCY (busulfan, cyclophosphamide, and MeCCNU), prior to allogeneic hematopoietic stem cell transplantation. This arm serves as the active comparator to evaluate the addition of venetoclax in the experimental arm. |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Relapse-Free Survival (RFS) | Relapse-Free Survival (RFS) is defined as the time from the date of allogeneic hematopoietic stem cell transplantation (allo-HSCT) to the first documented relapse of the primary disease or death from any cause, whichever occurs first. Participants who remain alive and relapse-free will be censored at the time of last follow-up. | From the date of transplantation until relapse or death from any cause, assessed up to 24 months |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Overall Survival (OS) | Overall survival (OS) is defined as the time from the date of transplantation to death from any cause. Patients who are alive at the last follow-up will be censored. Survival curves will be estimated using the Kaplan-Meier method. | Up to 36 months post-transplantation |
Non-Relapse Mortality (NRM) | Non-relapse mortality (NRM) is defined as death from any cause other than disease relapse after transplantation. Competing risk analysis will be used to assess NRM incidence between groups. | Up to 36 months post-transplantation |
Relapse Rate | Relapse rate refers to the cumulative incidence of disease recurrence post-transplantation, assessed through bone marrow evaluation, flow cytometry, and molecular markers. Competing risk models will be applied for statistical analysis. | Up to 36 months post-transplantation |
Measurable Residual Disease (MRD) Status | MRD will be assessed by multiparameter flow cytometry and/or molecular techniques at scheduled timepoints after transplantation to evaluate minimal residual leukemia. MRD positivity and conversion dynamics will be compared between groups. | Assessed monthly during the first 6 months, and then every 3 months until 24 months post-transplantation |
Treatment-Related Adverse Events | Incidence and severity of treatment-related adverse events, including hematologic and non-hematologic toxicities, will be evaluated and graded according to NCI-CTCAE v5.0. Events will be compared between the VEN-BUCY and BUCY groups. | From start of conditioning until 28 days after transplantation, and during follow-up up to 3 months |
Incidence of Acute Graft-versus-Host Disease (aGVHD) | Acute GVHD will be assessed and graded based on MAGIC (Mount Sinai Acute GVHD International Consortium) criteria. The cumulative incidence of grade II-IV and grade III-IV aGVHD will be compared between the VEN-BUCY and BUCY groups. | From day of stem cell infusion to day 100 post-transplantation |
Incidence of Chronic Graft-versus-Host Disease (cGVHD) | Chronic GVHD will be evaluated according to the 2014 NIH consensus criteria. The cumulative incidence of overall and moderate-to-severe cGVHD will be recorded and compared between the two groups. | From day 100 post-transplantation to 36 months |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Kind, Erwachsene
Mindestalter
12 Years
Zugelassene Geschlechter
Alle
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)
First Affiliated Hospital of Zhejiang UniversityVerantwortliche Partei
Yanmin Zhao, Hauptprüfer, Dr, First Affiliated Hospital of Zhejiang University
Zentrale Studienkontakte
Kontakt: Yanmin Zhao, MD, +8657187236706, [email protected]
Kontakt: Zhao, [email protected]
1 Studienstandorte in 1 Ländern
Zhejiang
The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310006, China
Yanmin Zhao, MD, Kontakt, 057187236706, [email protected]
Offene Rekrutierung