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

NCT ID: NCT07052422

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2029-12-31

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).

Detailed Description

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potent curative approach for myeloid malignancies, but outcomes post-transplantation of older population were unsatisfactory. The conditioning regimen is an essential factor affecting outcomes post-transplantation. Currently, the optimal conditioning for older patients with myeloid malignancies remains unclear. Myeloablative conditioning (MAC) regimens like busulfan plus cyclophosphamide, and busulfan plus fludarabine (Bu4Flu4-5) have low relapse rates, but high non-relapse mortality (NRM) is observed in older patients with myeloid malignancies. The development of reduced-intensity conditioning (RIC) regimens such as Bu2Flu5 has decreased NRM and enhanced the feasibility of allo-HSCT in older patients with myeloid malignancies, but it appears to have higher relapse rate. Neither conventional MAC nor RIC regimens benefit older patients with myeloid malignancies. In recent years, some studies reported that the introduction of venetoclax (VEN) or decitabine (DAC) to MAC reduced relapse without increasing NRM in younger patients with high-risk myeloid malignancies. However, whether VEN and DAC combined with RIC regimen reduce relapse without increasing NRM, then improve survival in older patients with myeloid malignancies is unclear. Therefore, we conducted a randomized controlled study to compare the efficacy and safety of VEN+DAC+Bu2Flu4 with Bu2Flu5 in older patients with myeloid malignancies undergoing allo-HSCT.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VEN+DAC+Bu2Flu4

Venetoclax+Decitabine+Busulfan+Fludarabine

Group Type: EXPERIMENTAL

Venetoclax (VEN)

Intervention Type: DRUG

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

Decitabine (DAC)

Intervention Type: DRUG

Decitabine (DAC) was administered at 20mg/m2/day on days

-10 to -8.

Busulfan (Bu)

Intervention Type: DRUG

Busulfan (Bu) was administered at 3.2 mg/kg/day on days

-5 to -4.

Fludarabine (Flu)

Intervention Type: DRUG

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

Bu2Flu5

Busulfan+Fludarabine

Group Type: ACTIVE_COMPARATOR

Busulfan (Bu)

Intervention Type: DRUG

Busulfan (Bu) was administered at 3.2 mg/kg/day on days

-5 to -4.

Fludarabine (Flu)

Intervention Type: DRUG

Fludarabine (Flu) was administered at 30mg/m2/day on days -6 to -2.

Interventions

Venetoclax (VEN)

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

Intervention Type: DRUG

Decitabine (DAC)

Decitabine (DAC) was administered at 20mg/m2/day on days

-10 to -8.

Intervention Type: DRUG

Busulfan (Bu)

Busulfan (Bu) was administered at 3.2 mg/kg/day on days

-5 to -4.

Intervention Type: DRUG

Fludarabine (Flu)

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

Intervention Type: DRUG

Fludarabine (Flu)

Fludarabine (Flu) was administered at 30mg/m2/day on days -6 to -2.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 60-75 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qifa Liu

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Central Contacts

Qifa Liu

Role: CONTACT

liuqifa628@163.com

+86-020-62787883

Qifa Liu

Role: CONTACT

liuqifa628@163.com

+86-020-61641611

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Other Identifiers

NFEC-2025-260

Identifier Type: -

Identifier Source: org_study_id