Venetoclax Combined with Intensive Therapy for Acute Myeloid Leukemia Patients with Lower Early Peripheral Blast Clearance Rate After Standard Induction Therapy

NARecruitingINTERVENTIONAL
Enrollment

83

Participants

Timeline

Start Date

October 31, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

October 31, 2027

Conditions
LeukemiaLeukemia, MyeloidLeukemia, Myeloid, Acute
Interventions
DRUG

Venetoclax

Venetoclax in the EPBCRlow cohort will be added to the ongoing 3+7 regimen. In the first induction cycle: venetoclax needs to be ramped up: 100 mg on day 5, 200mg on day 6, and 400mg on days 7-14, orally once daily. In the second induction (if required), venetoclax 400mg will be administered orally once daily on days 5-14 without a dose ramp-up schedule. Venetoclax in the EPBCRlow cohort during consolidation therapy: 400mg on days 1-7, orally once daily, along with the consolidation chemotherapy.

DRUG

Idarubincin

Idarubicin (IDA): 10mg/m\^2/d (age \<60 years old) or 6mg/m\^2/d on days 1-3, intravenously (IV).

DRUG

Cytarabine

During induction therapy: 100mg/m2/d on days 1-7, IV. During consolidation therapy: intermediate-dose cytarabine for age \>55 years old: 1.0g/m\^2 q12h on days 1-3, high-dose cytarabine for age ≦55 years old: 2g/m2 q12h on days 1-3.

Trial Locations (1)

226001

RECRUITING

Affiliated hospital of Nantong University, Nantong

All Listed Sponsors
lead

Affiliated Hospital of Nantong University

OTHER