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

Chinese PLA General Hospital (301 Hospital)

Status and phase: Enrolling; Phase 2

Conditions: First Line Therapy; Acute Myeloid Leukemia

Treatments: Drug: "3+7"; Drug: Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor

Study type: Interventional

Funder types: Other

Identifiers

NCT06928376

KY-2024-3-40-2

Details and patient eligibility

About

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).

Full description

Despite the availability of hematopoietic stem cell transplantation and the emergence of many new therapeutic drugs, the prognosis of newly diagnosed acute myeloid leukemia is still poor.Over the past years, combination chemotherapy with anthracycline and standard dose cytarabine (standard "3+7" induction therapy) remains the standard induction. In order to improve the outcome of patients with de novo AML, we developed a venetoclax combined with CACAG regimen in the treatment of de novo AML. In this study, we intent to compare the efficacy and safety of venetoclax combined with CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed intermediate- or high-risk acute myeloid leukemia.

Enrollment: 160 estimated patients

Sex: All

Ages: 14 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Age 14 to 75 years (no gender limitation) Newly diagnosed with intermediate- or high-risk AML (excluding M3) Liver function: ALT and AST ≤ 2.5 times upper limit of normal; bilirubin ≤ 2 times upper limit of normal Renal function: creatinine ≤ upper limit of normal No uncontrolled infections, organ dysfunction, or severe mental illness ECOG performance status score of 0-2 and predicted survival ≥ 4 months No severe allergic constitution

Exclusion criteria

Allergy or contraindication to the study drug Pregnant or breastfeeding female patients Known history of alcohol or drug addiction (due to potential non-compliance) Mental illness or conditions preventing protocol compliance Less than 6 weeks after major organ surgery Liver function: ALT and AST > 2.5 times upper limit of normal; bilirubin > 2 times upper limit of normal Renal function: creatinine > upper limit of normal Deemed unsuitable for the clinical trial (poor compliance, substance abuse, etc.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Venetoclax Combined With CACAG Regimen

Experimental group

Description:

The CACAG+Venetoclax regimen has a total treatment period of 1 week, with a treatment cycle every 4 weeks, and a total of 1 course of treatment. Chidamide: 30 mg, twice a week, for a total of 2 administrations; Azacitidine: 75 mg/m\^2 from day 1 to day 7; Cytarabine (Ara-C): 75-100 mg/m\^2 every 12 hours from day 1 to day 7; Aclarubicin: 20 mg/m\^2 on days 1, 3, and 5; Recombinant human granulocyte colony-stimulating factor (G-CSF): 300 μg/day, continued until neutrophil recovery and white blood cell count is ≥20,000/μL; Venetoclax: 100 mg on day 1, 200 mg on day 2, 400 mg from day 3 to day 14, when used in combination with azole drugs, the dosage is reduced to 100 mg/day.

Treatment:

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

"3+7" Regimen

Active Comparator group

Description:

Idarubicin+cytarabine(IA) regimen or daunorubicin+cytarabine(DA) regimen for newly diagnosed AML.Recipients were randomized and those entering this group received IA or DA induction chemotherapy. With the IA regimen,recipients received idarubicin(8-10 mg/m2) for three days and cytarabine(75-100 mg/m2, every 12 hrs) for seven days. With the DA regimen,recipients received daunorubicin(60 mg/m2)for three days and cytarabine(75-100 mg/m2,every 12 hrs)for seven days.

Treatment:

Drug: "3+7"