Clinical trial · Interventional
Clinical Trial Protocol for the Combined Use of VAG in the Treatment of ND-AML
Clinical Trial Protocol for the Combined Use of Azacitidine, Venetoclax, and Granulocyte Colony-Stimulating Factor in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) (Phase IIb, Single-arm, Prospective, Single-center Study)
NCT06536010CI-TRIAL-00079428recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a clinical efficacy study evaluating the VAG regimen in the treatment of newly diagnosed acute myeloid leukemia (AML). The main objectives of the study are to assess the efficacy and safety of the VAG regimen and to explore the synergistic mechanisms of VAG in combating AML.
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 | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Venetoclax 100 mg d1，200 mg d2，400 mg d3-28； | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- VAG regimen in the treatment of newly diagnosed acute myeloid leukemia (AML)
- description
- AZA: 75mg/m2 on days 1-7 VEN: 100mg on day 1, 200mg on day 2, 400mg on days 3-28 G-CSF: 50-600ug/day, starting on day 1 (adjusted based on WBC count of 10-25\*10E9/L) In the induction phase of the ND-AML treatment protocol, VEN+AZA+G-CSF is administered. At the end of the induction phase, the efficacy is evaluated. If the patient achieves complete remission (CR), the original treatment protocol is continued for consolidation. If the patient achieves partial remission (PR), the original treatment protocol is repeated for induction until the patient achieves CR or shows no response (NR), progressive disease (PD), or relapse (PR/NR/PD). If the patient shows no response or progressive disease, the study is concluded.
- interventionNames
- Drug: Venetoclax 100 mg d1，200 mg d2，400 mg d3-28；
Primary outcomes (1)
- measure
- Complete Remission (CR)
- timeFrame
- The period of 2 months from the start of treatment.
- description
- A. No symptoms or signs of leukemia cell infiltration, normal or near-normal life; B. Blood counts: Hb ≥ 100g/L (males) or ≥ 90g/L (females and children), absolute neutrophil count ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L. No leukemia cells in peripheral blood leukocyte classification; C. Bone marrow morphology: Less than or equal to 5% of myeloblasts (type I + type II) (primitive monocytes + immature monocytes or primitive lymphocytes + immature lymphocytes), normal red blood cells and megakaryocytes; D. No extramedullary leukemia (no lymphadenopathy, splenomegaly, skin/gum infiltration, testicular masses, central nervous system involvement).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 18 and 75 years, regardless of gender. * Diagnosis of AML (excluding APL) according to the 2022 World Health Organization (WHO) diagnostic criteria. * ECOG performance status of 0-2. * For female participants of childbearing potential or male participants with female partners of childbearing potential, effective contraceptive measures must be taken throughout the entire treatment period and for 6 months after the treatment period. * Expected survival of at least 3 months. * Ability to understand and willingness to participate in the study, and signing an informed consent form. Exclusion Criteria: * Acute promyelocytic leukemia (M3 subtype). * Central nervous system leukemia. * Severe uncontrolled infection or other major diseases. * Heart failure: Ejection fraction (EF) \< 50%, New York Heart Association (NYHA) class II or above. * Impaired liver or kidney function: Serum total bilirubin ≥ 2.0 mg/dl, AST ≥ 3 times the upper limit of normal, serum creatinine clearance rate (Ccr) ≥ 50 ml/min, arterial oxygen saturation (SpO2) \< 92%. * Human immunodeficiency virus (HIV) positive. * Active hepatitis B or C. * Pregnant or lactating women. * Other conditions in which the investigator deems the participant unsuitable for the study.
References
Publications (0)
Data not yet available
No reference posted for this study.