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VCA Regimen Followed by D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

NCT05603884 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-02-19

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of Venetoclax Combining Chidamide and Azacitidine (VCA) Followed by D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Conditions

  • Leukemia, Myeloid, Acute
  • AML Stage, Adult

Interventions

DRUG

Venetoclax Combining Chidamide and Azacitidine (VCA) regimen followed by dicitabine combined with liposome mitoxantrone, cytarabine, and G-CSF (D-MAG) regimen

venetoclax combining chidamide and azacitidine (VCA) 28 days per cycle × 2 cycles； 1) chidamide 30mg biw × 2weeks；2) venetoclax 200mg/d × 2 weeks 3) azacitidine 100mg/d d1-7 dicitabine combined with liposome mitoxantrone, cytarabine, and G-CSF (D-MAG) regimen 28 days per cycle ×2 cycles； 1）dicitabine 25mg d1-3，2）liposome mitoxantrone 20mg d4，3）cytarabine 10mg/m2 Q12h d1-7 4）G-CSF 300ug d-1 until WBC \> 20×109/L

Sponsors & Collaborators

  • Chipscreen Biosciences, Ltd.

    collaborator INDUSTRY

  • CSPC Pharmaceutical Group Limited

    collaborator INDUSTRY

  • Fujian Provincial Hospital

    collaborator OTHER

  • Fujian Cancer Hospital

    collaborator OTHER_GOV

  • Zhangzhou manicipal hospital of Fujian Province

    collaborator UNKNOWN

  • Jieyang People's Hospital

    collaborator OTHER

  • Huizhou Municipal Central Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Xiamen University

    lead OTHER

Principal Investigators

  • Bing Xu, M.D. · The First Affiliated Hospital of Xiamen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

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 NCT05603884 on ClinicalTrials.gov