VEN+DAC+Bu2Flu4 vs Bu2Flu5 Conditioning Regimen for Elderly Myeloid Malignancies Undergoing Allo-HSCT

NCT07052422 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: NFEC-2025-260
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the efficacy and safety of venetoclax+decitabine+busulfan+fludarabine (VEN+DAC+Bu2Flu4) regimen with busulfan+fludarabine (Bu2Flu5) regimen in older patients with myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Conditions

Older Patients; Myeloid Malignancies; Conditioning; Hematopoietic Stem Cell Transplantation (HSCT)

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS) rate

  Will calculate time from random assignment until disease progression or relapse or death from any cause

  2 year

Secondary Outcomes (3)

• Overall survival (OS) rate

  2 year

• Relapse incidence

  2 year

• Non-relapse mortality (NRM) incidence

  2 year

Study Arms (2)

VEN+DAC+Bu2Flu4

EXPERIMENTAL

Venetoclax+Decitabine+Busulfan+Fludarabine

Drug: Venetoclax (VEN); Drug: Decitabine (DAC); Drug: Busulfan (Bu); Drug: Fludarabine (Flu)

Bu2Flu5

ACTIVE COMPARATOR

Busulfan+Fludarabine

Drug: Busulfan (Bu); Drug: Fludarabine (Flu)

Interventions

Venetoclax (VEN) DRUG

Venetoclax (VEN) was administered at 400mg/day on days -10 to -4.

VEN+DAC+Bu2Flu4

Decitabine (DAC) DRUG

Decitabine (DAC) was administered at 20mg/m2/day on days -10 to -8.

VEN+DAC+Bu2Flu4

Busulfan (Bu) DRUG

Busulfan (Bu) was administered at 3.2 mg/kg/day on days -5 to -4.

Bu2Flu5; VEN+DAC+Bu2Flu4

Fludarabine (Flu) DRUG

Fludarabine (Flu) was administered at 30mg/m2/day on days -5 to -2.

VEN+DAC+Bu2Flu4

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years
• Acute myeloid leukaemia in first complete remission or myelodysplastic syndrome
• Willing to undergo the first allo-HSCT
• Eastern Cooperative Oncology Group performance status of 0-2

You may not qualify if:

• Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
• Patients with any conditions not suitable for the trial (investigators' decision)

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Related Publications (5)

• Ling Y, Xuan L, Xu N, Huang F, Fan Z, Guo Z, Xu X, Liu H, Lin R, Yu S, Zhang H, Jin H, Wu M, Liu C, Liang X, Ou R, Zhang Y, Liu X, Qu H, Zhai X, Sun J, Zhao Y, Liu Q. Busulfan Plus Fludarabine Compared With Busulfan Plus Cyclophosphamide for AML Undergoing HLA-Haploidentical Hematopoietic Cell Transplantation: A Multicenter Randomized Phase III Trial. J Clin Oncol. 2023 Oct 10;41(29):4632-4642. doi: 10.1200/JCO.23.00101. Epub 2023 Jun 19.

  PMID: 37335960 BACKGROUND

• Rambaldi A, Grassi A, Masciulli A, Boschini C, Mico MC, Busca A, Bruno B, Cavattoni I, Santarone S, Raimondi R, Montanari M, Milone G, Chiusolo P, Pastore D, Guidi S, Patriarca F, Risitano AM, Saporiti G, Pini M, Terruzzi E, Arcese W, Marotta G, Carella AM, Nagler A, Russo D, Corradini P, Alessandrino EP, Torelli GF, Scime R, Mordini N, Oldani E, Marfisi RM, Bacigalupo A, Bosi A. Busulfan plus cyclophosphamide versus busulfan plus fludarabine as a preparative regimen for allogeneic haemopoietic stem-cell transplantation in patients with acute myeloid leukaemia: an open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. 2015 Nov;16(15):1525-1536. doi: 10.1016/S1470-2045(15)00200-4. Epub 2015 Sep 28.

  PMID: 26429297 BACKGROUND

• Devine SM, Owzar K, Blum W, Mulkey F, Stone RM, Hsu JW, Champlin RE, Chen YB, Vij R, Slack J, Soiffer RJ, Larson RA, Shea TC, Hars V, Sibley AB, Giralt S, Carter S, Horowitz MM, Linker C, Alyea EP. Phase II Study of Allogeneic Transplantation for Older Patients With Acute Myeloid Leukemia in First Complete Remission Using a Reduced-Intensity Conditioning Regimen: Results From Cancer and Leukemia Group B 100103 (Alliance for Clinical Trials in Oncology)/Blood and Marrow Transplant Clinical Trial Network 0502. J Clin Oncol. 2015 Dec 10;33(35):4167-75. doi: 10.1200/JCO.2015.62.7273. Epub 2015 Nov 2.

  PMID: 26527780 BACKGROUND

• Xuan L, Dai M, Jiang E, Wang Y, Huang F, Fan Z, Xu N, Nie D, Liang X, Chen H, Ye J, Shi P, Liu H, Jin H, Lin R, Yan C, Zhang Y, Sun J, Han M, Liu Q. The effect of granulocyte-colony stimulating factor, decitabine, and busulfan-cyclophosphamide versus busulfan-cyclophosphamide conditioning on relapse in patients with myelodysplastic syndrome or secondary acute myeloid leukaemia evolving from myelodysplastic syndrome undergoing allogeneic haematopoietic stem-cell transplantation: an open-label, multicentre, randomised, phase 3 trial. Lancet Haematol. 2023 Mar;10(3):e178-e190. doi: 10.1016/S2352-3026(22)00375-1. Epub 2023 Jan 23.

  PMID: 36702138 BACKGROUND

• Zheng X, Gao H, Lu N, Wang M, Zhang H, Zheng Y, Shen B, Cao Y, Chen X, Zhai W, Wei J, Yang D, Zhang R, Pang A, Feng S, Jiang E, Han M. Efficacy of venetoclax combined with decitabine conditioning regimen for allogeneic hematopoietic stem cell transplantation in high-risk and elderly patients with myeloid neoplasms. Ann Hematol. 2023 Dec;102(12):3603-3611. doi: 10.1007/s00277-023-05500-2. Epub 2023 Oct 25.

  PMID: 37878011 BACKGROUND

MeSH Terms

Interventions

venetoclax; Decitabine; Busulfan; fludarabine; Influenza Vaccines

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Butylene Glycols; Glycols; Alcohols; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Qifa Liu

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qifa Liu

CONTACT

+86-020-62787883; liuqifa628@163.com

Qifa Liu

CONTACT

+86-020-61641611; liuqifa628@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: July 4, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share