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Venetoclax Combined With CACAG Regimen Versus 3+7 Regimen in the Treatment of Acute Monocytic Leukemia: A Prospective, Randomized, Controlled Study

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study is a multicenter, randomized, prospective Phase II clinical trial designed to compare the effectiveness of two treatment approaches for patients with acute monocytic leukemia.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 60
Healthy Volunteers: f
View:

• Voluntary participation with written informed consent signed by the participant or a legal guardian; willingness to comply with all study procedures.

• Age 14 to 60 years at screening, no gender restriction.

• Diagnosis of acute monocytic leukemia according to the 2016 WHO classification, excluding acute promyelocytic leukemia.

• No history of severe allergic reactions.

• Liver function: ALT and AST ≤ 2.5 × upper limit of normal (ULN); total bilirubin ≤ 2 × ULN.

• Renal function: serum creatinine ≤ 1.5 × ULN

• No uncontrolled infection or severe psychiatric disorder.

• ECOG performance status 0-3; life expectancy ≥ 4 months.

Locations
Other Locations
China
Air Force Medical Center, PLA
RECRUITING
Beijing
Chinese PLA General Hospital
RECRUITING
Beijing
PLA Strategic Support Force's Characteristic Medical Center
RECRUITING
Beijing
Contact Information
Primary
Liping Dou, Doctor
lipingruirui@163.com
+8613681207138
Backup
Daihong Liu, Doctor
daihongrm@163.com
+8613681171597
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2029-10-31
Participants
Target number of participants: 204
Treatments
Experimental: Venetoclax Combined with CACAG Regimen
Participants assigned to Venetoclax Combined with CACAG Regimen will receive a combination regimen consisting of venetoclax plus the CACAG. The CACAG regimen includes azacitidine administered at a dose of 75 mg/m² subcutaneously on days 1-7; cytarabine given at a dose of 75-100 mg/m² q12h intravenously on days 1-5; aclarubicin administered at a dose of 20 mg intravenously on days 1, 3, and 5; and chidamide given orally at a dose of 30 mg twice a week for two weeks. Venetoclax is administered orally with a dose ramp-up schedule: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3 through 14. If an azole antifungal agent is co-administered, the dose of venetoclax is reduced to 100 mg daily. Granulocyte colony-stimulating factor (G-CSF) is given subcutaneously at 300 μg per day until neutrophil recovery. Each treatment cycle lasts 4-5 weeks, with a total of 2 cycles.
Active_comparator: Standard 3+7 Regimen
Participants assigned toStandard 3+7 Regimen will receive the standard 3+7 induction regimen. Daunorubicin is administered intravenously at a dose of 60 mg/m² on days 1-3. Cytarabine is given intravenously at a dose of 75-100 mg/m² twice daily on days 1-7. Each treatment cycle lasts 4-5 weeks, with a total of 2 cycles. Participants who do not achieve at least a partial response after the first cycle will be withdrawn from the study and receive alternative treatment according to clinical guidelines.
Sponsors
Leads: Chinese PLA General Hospital
Collaborators: Air Force Medical Center of PLA, PLA Strategic Support Force's Characteristic Medical Center

This content was sourced from clinicaltrials.gov

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