RecruitingPhase 2NCT05603884

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

Venetoclax Combining Chidamide and Azacitidine (VCA) Regimen Followed by Dicitabine Combined With Liposome Mitoxantrone, Cytarabine, and G-CSF (D-MAG) Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) : A Multicenter, Prospective, Single Arm Clinical Trial


Sponsor

The First Affiliated Hospital of Xiamen University

Enrollment

66 participants

Start Date

Dec 1, 2022

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination chemotherapy approach (VCA followed by D-MAG regimen) for older adults with newly diagnosed acute myeloid leukemia (AML) who cannot tolerate standard intensive chemotherapy due to age or other health conditions. The goal is to find an effective but more tolerable treatment option for this vulnerable population. **You may be eligible if...** - You are 60 or older - You have been newly diagnosed with AML (not APL/M3 type) - You cannot receive standard intensive chemotherapy (due to age, other health conditions, or your preference) - Your kidneys and liver are functioning adequately - Doctors expect you to live at least 3 more months **You may NOT be eligible if...** - You have the APL (M3) subtype of AML - You have severe kidney or liver problems - You have serious heart conditions or uncontrolled infections - You have previously received treatment for this AML Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVenetoclax 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


Locations(1)

Bing Xu

Xiamen, Fujian, China

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NCT05603884


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