VA-CAG Two-Week vs. Three-Week Regimen for Induction Remission in Newly Diagnosed Acute Myeloid Leukemia.

Phase 2Not Yet RecruitingNCT07642453

Hematology department of the 920th hospital110 enrolled

Overview

Objective: This clinical trial aims to compare the efficacy and safety of the VA-CAG regimen administered as a two-week schedule versus a three-week schedule for induction remission in acute myeloid leukemia (AML). Key Research Questions: 1. Is the efficacy of the two-week VA-CAG regimen equivalent to that of the three-week regimen in inducing remission in AML? 2. Does the two-week VA-CAG regimen reduce treatment-related adverse events compared to the three-week regimen? Methods: Researchers will compare the efficacy and safety of the two-week VA-CAG regimen with the three-week regimen for induction remission in AML. Study participants will be randomly assigned to receive standard treatment with either the two-week or three-week VA-CAG regimen. Patients are required to attend monthly follow-up visits for a total of one year. At each follow-up, the following assessments will be performed: complete blood count, liver and kidney function tests, bone marrow aspiration, flow cytometric measurement of minimal residual disease (MRD), and/or fusion gene analysis, along with monitoring of other efficacy endpoints and adverse reactions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

110

Conditions

Acute Myeloid Leukemia (AML)

Interventions

Venetoclax,Azacitidine,Arubicin,Cytarabine,G-CSF.DRUG

Specific Medication for the VACAG Protocol: 1. Two-week regimen group Azacitidine: 75 mg/m² on days 1-7 by subcutaneous injection, Venetoclax: 100 mg on Day 1, 200 mg on Day 2, 400 mg on Days 3-14, oral, Arubicin: 12-14 mg/m² on days 1, 3, 5, and 7 (IV infusion), Cytarabine: 10 mg/m² every 12 hours on days 1-7, subcutaneous injection, G-CSF: 5 μg/kg on days 0-8; discontinue if WBC \> 20 × 10⁹/L; 2. Three-week regimen group Venetoclax administered for 21 days; dosage and administration are the same as in the 2-week regimen group.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diagnosis of acute myeloid leukemia confirmed according to NCCN guidelines; 2. Age 18-75 years; 3. Body weight 30-100 kg; 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3; 5. No significant organ dysfunction (echocardiographic ejection fraction \>45%; bilirubin \<2 times the upper limit of normal; AST and ALT \<3 times the upper limit of normal; serum creatinine \<2 times the upper limit of normal); 6. No severe infections; 7. Study participants voluntarily agree to participate in this clinical trial and sign an informed consent form. Exclusion Criteria: 1. Patients with other types of diseases; 2. Patients with a projected survival of less than 1 month; 3. History of prior treatment; 4. Severe psychiatric or neurological disorders that impair the ability to provide informed consent and/or report or observe adverse events; 5. Other circumstances deemed unsuitable for enrollment by the investigator.

Outcomes

Primary Outcomes

CR rate

Time frame: At the end of Cycle 1 of induction (each cycle is about 30 days)

Secondary Outcomes

Adverse Events

Safety and tolerability analysis will be assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.

Time frame: From the first day of induction until the starting day of the next cycle of therapy (up to 60 days）

Duration of remission

DOR was defined as the period from the time to acquire CR until relapse

Time frame: From the date of the first remission until the date of relapse (assessed up to 30 months)

Minimal Residual Disease negative remission rate (MRD-negative rate)

Percentage of participants who converted to MRD \< 10\^-3 by flow cytometry before initiation of consolidation therapy.

Time frame: After 1 cycle of induction (each cycle is about 30 days)