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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2-week VACAG regimen for newly diagnosed acute myeloid leukemia | Experimental | Specific Medication for the 2-week VACAG regimen Protocol: 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, Recombinant human granulocyte colony-stimulating factor: 5 μg/kg on days 0-8; discontinue if WBC > 20 × 10⁹/L; |
|
| 3-week VACAG regimen for newly diagnosed acute myeloid leukemia | Active Comparator | Specific Medication for the 3-week VACAG regimen Protocol: 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 3-21, 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, Recombinant human granulocyte colony-stimulating factor: 5 μg/kg on days 0-8; discontinue if WBC > 20 × 10⁹/L; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venetoclax,Azacitidine,Arubicin,Cytarabine,G-CSF. | Drug | Specific Medication for the VACAG Protocol:
|
| Measure | Description | Time Frame |
|---|---|---|
| CR rate | At the end of Cycle 1 of induction (each cycle is about 30 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Safety and tolerability analysis will be assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0. | From the first day of induction until the starting day of the next cycle of therapy (up to 60 days) |
| Duration of remission |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall Survival will be defined as the time from administration of the initial doses until death from any cause. | From the first day of induction until the date of death from any cause, assessed up to 30 months. |
| Relapse-free survival |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang sanbin | Contact | 13187424131 | 1739701184@qq.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 8, 2026 | May 25, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C579720 | venetoclax |
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|
DOR was defined as the period from the time to acquire CR until relapse |
| 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. | After 1 cycle of induction (each cycle is about 30 days) |
Relapse-free survival will be defined as the time since date of CR until either relapse or death in remission.
| From the first day of induction until the date of relapse or the date of death from any cause, assessed up to 30 months. |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |