RecruitingPhase 2NCT06928376

A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients

A Multicenter, Prospective, Randomized Controlled Study of the Standard "3+7" Regimen Versus Venetoclax Combined With CACAG Regimen in Newly Diagnosed Adult Patients With Intermediate- and High-risk Acute Myeloid Leukemia


Sponsor

Chinese PLA General Hospital

Enrollment

160 participants

Start Date

Apr 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to compare the efficacy and safety of venetoclax combined with the CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed intermediate- or high-risk acute myeloid leukemia (AML).


Eligibility

Min Age: 14 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares two different chemotherapy approaches for adults and older teens newly diagnosed with moderate-to-high-risk acute myeloid leukemia (AML), a type of blood cancer. One approach uses a traditional chemotherapy regimen ("3+7") and the other uses a newer combination including a drug called venetoclax. **You may be eligible if...** - You are between 14 and 75 years old - You have been newly diagnosed with intermediate- or high-risk AML (not including a subtype called M3) - Your liver and kidney function are within acceptable levels - You do not have severe uncontrolled infections or major organ problems - You are in reasonably good physical health **You may NOT be eligible if...** - You are allergic to any of the study drugs - You are pregnant or breastfeeding - You have a history of alcohol or drug addiction - You have a mental illness that prevents following the treatment plan - You had major surgery in the past 6 weeks 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

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

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

DRUG"3+7"

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


Locations(1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

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NCT06928376


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