Acute Myeloid Leukemia (AML)
Conditions
Brief summary
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.
Interventions
DRUGVenetoclax,Azacitidine,Arubicin,Cytarabine,G-CSF.
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.
Sponsors
Hematology department of the 920th hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR rate | At the end of Cycle 1 of induction (each cycle is about 30 days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | From the first day of induction until the starting day of the next cycle of therapy (up to 60 days） | Safety and tolerability analysis will be assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0. |
| Duration of remission | From the date of the first remission until the date of relapse (assessed up to 30 months) | DOR was defined as the period from the time to acquire CR until relapse |
| Minimal Residual Disease negative remission rate (MRD-negative rate) | After 1 cycle of induction (each cycle is about 30 days) | Percentage of participants who converted to MRD \< 10\^-3 by flow cytometry before initiation of consolidation therapy. |
Contacts
CONTACTWang sanbin
Outcome results
None listed