Venetoclax Combined With CACAG Regimen Versus "3+7" Regimen in the Treatment of Acute Monocytic Leukemia

Official title

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

Overview

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.

Detailed description

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.

A total of 204 participants, aged 14 to 60 years, will be enrolled across multiple study sites in China. Participants will be randomly assigned to one of two treatment groups:

Group 1: Venetoclax combined with the CACAG (cytarabine, azacitidine, chidamide, aclarubicin and granulocyte colony-stimulating factor) regimen This group will receive a combination of azacitidine, cytarabine, aclarubicin, chidamide, and venetoclax, along with granulocyte colony-stimulating factor (G-CSF) support.

Group 2: The standard "3+7" regimen This group will receive standard induction chemotherapy with daunorubicin and cytarabine.

The total study treatment period is about 8-10 weeks, consisting of two treatment cycles. Participants who do not achieve at least a partial response after the first cycle may be withdrawn from the study to receive alternative treatment as recommended by clinical guidelines.

The main goal of the study is to evaluate and compare the effectiveness of these two regimens in treating acute monocytic leukemia. Outcomes will include treatment response, safety, and overall patient outcomes during the study period.

Interventions

• Drug CACAG+VEN
  Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor 1. Azacytidine (75 mg/m2/day, days 1 to 7). 2. Cytarabine (75-100 mg/m2 every 12 hrs, days 1 to 5). 3. Aclacinomycin (20 mg/day, days 1,3,5). 4. Chidamide (30 mg/day , days 1,4,8,11). 5. 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
• Drug 3+7
  IA regimen: 1. Idarubicin (8-10 mg/m2) for 3 days. 2.Cytarabine (75-100mg/m2, every 12 hrs) for 7 days. DA regimen: 1.Daunorubicin(60 mg/m2) for 3 days. 2.Cytarabine (75-100mg/m2, every 12 hrs) for 7 days. MA regimen: 1.Mitoxantrone (12 mg/m2) for 3 days. 2.Cytarabine (75-100mg/m2, every 12 hrs) for 7 days.

Primary outcome measures

• Composite Complete Remission Rate [Time frame: At the end of Cycle 2 (each cycle is 28 days)]

Secondary outcome measures (12)

• Complete Remission Rate after Cycle 1 [Time frame: At the end of Cycle 1 (each cycle is 28 days)]
• Complete Remission with Incomplete Count Recovery Rate after Cycle 1 [Time frame: At the end of Cycle 1 (each cycle is 28 days)]
• Overall Response Rate after Cycle 1 [Time frame: At the end of Cycle 1 (each cycle is 28 days)]
• Partial Remission Rate after Cycle 1 [Time frame: At the end of Cycle 1 (each cycle is 28 days)]
• Minimal Residual Disease Negative Rate after Cycle 1 [Time frame: At the end of Cycle 1 (each cycle is 28 days)]
• Composite Complete Remission Rate after Cycle 1 [Time frame: At the end of Cycle 1 (each cycle is 28 days)]
• Complete Remission Rate after Cycle 2 [Time frame: At the end of Cycle 2 (each cycle is 28 days)]
• Complete Remission with Incomplete Count Recovery Rate after Cycle 2 [Time frame: At the end of Cycle 2 (each cycle is 28 days)]
• Partial Remission Rate after Cycle 2 [Time frame: At the end of Cycle 2 (each cycle is 28 days)]
• Minimal Residual Disease Negative Rate after Cycle 2 [Time frame: At the end of Cycle 2 (each cycle is 28 days)]
• Progression-Free Survival [Time frame: Up to 12 months after enrollment]
• Overall Survival [Time frame: Up to 12 months after enrollment]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• Known hypersensitivity or contraindication to any study drug.
• Pregnancy or lactation.
• Active infection.
• Long-term smoking or alcohol abuse that may interfere with study outcome evaluation.
• Psychiatric illness or other condition that prevents informed consent or compliance with study procedures.
• Major organ surgery within 6 weeks prior to enrollment.
• Abnormal liver function: total bilirubin > 2× ULN, ALT/AST > 2.5 × ULN; abnormal renal function: serum creatinine > 1.5 × ULN.
• Any condition deemed unsuitable for the study by the investigator (e.g., poor compliance, substance abuse).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 3 centers

• Air Force Medical Center, PLA — Beijing
• Chinese PLA General Hospital — Beijing
• PLA Strategic Support Force's Characteristic Medical Center — Beijing

Identifiers

NCT: NCT07512700 · 2025-761

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗