MedTrace Logo

VA-CIG Regimen for Previously Untreated Acute Myeloid Leukemia: A Multicenter Prospective Single-Arm Trial

NCT07514832 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-04-07

No results posted yet for this study

Summary

This is a multicenter, prospective, single-arm clinical study designed to evaluate the efficacy and safety of the VA-CIG regimen (venetoclax combined with azacitidine, idarubicin, low-dose cytarabine and granulocyte colony-stimulating factor \[G-CSF\]) as induction therapy for previously untreated patients with fit acute myeloid leukemia (AML) who are eligible for intensive chemotherapy. This study aims to evaluate the efficacy and safety of the VA-CIG regimen in the target patient population.

Conditions

  • AML (Acute Myeloid Leukemia)

Interventions

DRUG

Venetoclax, Azacitidine, Cytarabine, Idarubicin, G-CSF

* Venetoclax: 100 mg on Day 1, 200 mg on Day 2, 400 mg on Day 3, and 400 mg on Days 4-14, orally, once daily; * Azacitidine: 75 mg/m²/d, subcutaneous injection, on Days 1-7; * Cytarabine: 100 mg/m²/d, intravenous infusion, on Days 1-5; * Idarubicin: 6 mg/m²/d, intravenous infusion, on Days 1-3; * Human granulocyte colony-stimulating factor (G-CSF): 200 μg/m²/d, subcutaneous injection, from Day 0 until the white blood cell count \> 10×10⁹/L. One cycle lasts for 28 days

Sponsors & Collaborators

  • Beijing 302 Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2028-04-01
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07514832 on ClinicalTrials.gov