Clinical trial · Interventional
VA-CAG Two-Week vs. Three-Week Regimen for Induction Remission in Newly Diagnosed Acute Myeloid Leukemia.
VA-CAG Two-Week vs. Three-Week Regimen for Induction Remission in Newly Diagnosed Acute Myeloid Leukemia: A Prospective, Multicenter, Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Venetoclax,Azacitidine,Arubicin,Cytarabine,G-CSF. | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 2-week VACAG regimen for newly diagnosed acute myeloid leukemia
- description
- 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;
- interventionNames
- Drug: Venetoclax,Azacitidine,Arubicin,Cytarabine,G-CSF.
- type
- ACTIVE_COMPARATOR
- label
- 3-week VACAG regimen for newly diagnosed acute myeloid leukemia
- description
- 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;
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
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