Venetoclax+HMA+Aclarubicin Versus Venetoclax+HMA in Treatment-Naive Elderly Patients With AML

NCT05264883 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2023-05-30

No results posted yet for this study

Summary

This research is being done to assess the therapeutic efficacy and safety of a promising regimen (Venetoclax combined with Decitabine/Azacitidine and Aclarubicin) versus Venetoclax combined with Decitabine/Azacitidine in treatment-naive elderly patients with Acute Myeloid Leukemia.

This study involves the following:

Venetoclax, Decitabine/Azacitidine, Aclarubicin (investigational combination) Venetoclax and Decitabine/Azacitidine (per standard of care)

Conditions

Interventions

DRUG

Venetoclax-Decitabine/Azacitidine-Aclarubicin Association

Treatment with Venetoclax+Decitabine/Azacitidine+Aclarubicin

DRUG

Venetoclax-Decitabine/Azacitidine Association

Treatment with Venetoclax+Decitabine/Azacitidine

Sponsors & Collaborators

  • The Affiliated Jiangning Hospital of Nanjing Medical University

    collaborator OTHER
  • Huai'an First People's Hospital

    collaborator OTHER
  • Yancheng First People's Hospital

    collaborator OTHER
  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2023-06-28
Completion
2025-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT05264883 on ClinicalTrials.gov