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

NCT07052422 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-07-04

No results posted yet for this study

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)

Interventions

DRUG

Venetoclax (VEN)

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

DRUG

Decitabine (DAC)

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

DRUG

Busulfan (Bu)

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

DRUG

Fludarabine (Flu)

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

DRUG

Fludarabine (Flu)

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

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Qifa Liu · Nanfang Hospital, Southern Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-15
Primary Completion
2027-12-31
Completion
2029-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07052422 on ClinicalTrials.gov