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

ConditionAcute Myeloid Leukemia (AML)

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorHematology department of the 920th hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of acute myeloid leukemia confirmed according to NCCN guidelines;

Age 18-75 years;

Body weight 30-100 kg;

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3;

Disqualifiers

Patients with other types of diseases;

Patients with a projected survival of less than 1 month;

History of prior treatment;

Severe psychiatric or neurological disorders that impair the ability to provide informed consent and/or report or observe adverse events;

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

110 Participants

are divided into 2 treatment groups

Group A: 2-week VACAG regimen for newly diagnosed acute myeloid leukemiaExperimental treatment 1 intervention

Group B: 3-week VACAG regimen for newly diagnosed acute myeloid leukemiaActive comparator 1 intervention

Trial 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)

Other outcomes

Overall survival

Overall Survival will be defined as the time from administration of the initial doses until death from any cause.

Time frame

From the first day of induction until the date of death from any cause, assessed up to 30 months.

Relapse-free survival

Relapse-free survival will be defined as the time since date of CR until either relapse or death in remission.

Time frame

From the first day of induction until the date of relapse or the date of death from any cause, assessed up to 30 months.

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hematology department of the 920th hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: