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Venetoclax Plus CACAG Regimen for Newly Diagnosed Acute Myeloid Leukemia

NCT06068621 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-01-20

No results posted yet for this study

Summary

The purpose of this study is to compare the efficacy and safety of venetoclax combined with CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed acute myeloid leukemia.

Conditions

Interventions

DRUG

Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor

1. Azacytidine (75 mg/m2/day, days 1 to 7). 2. Cytarabine (75-100 mg/m2 bid, days 1 to 5). 3. Aclacinomycin(20 mg/day, days 1,3,5). 4. Chidamide (30 mg/day , days 1,4,8,11). 5. Venetoclax (400 mg/day, days 1 to 14,Combined with posaconazole reduced to 100 mg/day,Combined with voriconazole reduced to 200 mg/day ). 6. Granulocyte colony-stimulating factor (300 μg/day, day 0 until agranulocytosis recovery)

DRUG

"3+7"

IA regimen: 1. Idarubicin (8-10 mg/m2) for 3 days . 2. Cytarabine (75-100mg/m2, every 12 hrs) for 7 days. DA regimen: 1. Daunorubicin(60 mg/m2) for 3 days. 2. Cytarabine (75-100mg/m2, every 12 hrs) for 7 days.

Sponsors & Collaborators

  • 940 Hospital of the People's Liberation Army Joint Logistic Support Force

    collaborator OTHER

  • The General Hospital of Western Theater Command

    collaborator OTHER

  • The General Hospital of Northern Theater Command

    collaborator OTHER

  • The 960th Hospital of Joint Logistics Support Force of Chinese People's Liberation Army

    collaborator UNKNOWN

  • Air Force Military Medical University, China

    collaborator OTHER

  • Yantai Yuhuangding Hospital

    collaborator OTHER

  • People's Liberation Army (PLA) Strategic Support Force Characteristic Medical Center

    collaborator UNKNOWN

  • First Hospital of China Medical University

    collaborator OTHER

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • Daihong Liu, doctor · Chinese PLA General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-05-31
Completion
2025-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06068621 on ClinicalTrials.gov