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

March 31, 2026 updated by: Xiao-Ning Gao, Beijing 302 Hospital

A Multicenter, Prospective, Single-Arm Clinical Trial of Venetoclax in Combination With Azacitidine, Cytarabine, Idarubicin and G-CSF (VA-CIG) for Patients With Previously Untreated Acute Myeloid Leukemia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dr. Gao Xiaoning, Chief Physician, Professor
  • Phone Number: 86+01066947169
  • Email: gaoxn@263.net

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of acute myeloid leukemia (AML, excluding acute promyelocytic leukemia) confirmed by morphology, immunophenotyping and molecular genetics, in accordance with the WHO 2022 diagnostic criteria for AML;
  • Age 18-70 years, with no gender restriction;
  • No prior AML-related treatment has been received; exceptions are made for the use of hydroxyurea or similar agents during the diagnostic screening phase to control peripheral blood leukemic blasts;
  • Patients must be assessed as tolerable to intensive chemotherapy regimens; evaluation of tolerance to intensive chemotherapy shall be performed in accordance with the Ferrara 2013 criteria (Appendix A);
  • Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;
  • Serum creatinine ≤ 2.0 × upper limit of normal (ULN), or creatinine clearance > 40 mL/min calculated by the Cockcroft-Gault formula for glomerular filtration rate (GFR);
  • Total bilirubin ≤ 2 × ULN, and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 × ULN;
  • Left ventricular ejection fraction (LVEF) ≥ 45%, or LVEF measured by echocardiography (ECHO) within the normal range;
  • Expected survival > 3 months.

Exclusion Criteria:

  • Subjects with a history of myeloproliferative neoplasms (MPNs), including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation, and acute myeloid leukemia (AML) with BCR-ABL1 translocation;
  • Patients with a prior history of venetoclax or azacitidine (Aza) treatment for other diseases;
  • Known hypersensitivity to any component of the investigational medicinal products;
  • History of other concurrent malignancies within 2 years prior to enrollment, except:

Adequately treated carcinoma in situ of the cervix or breast; Basal cell carcinoma or localized squamous cell carcinoma of the skin; Previously controlled malignancies treated with radical surgical resection (or other curative modalities), etc.

  • Presence of uncontrolled severe infection or active bleeding;
  • Pregnant or lactating women;
  • Subjects with active, treatment-uncontrolled viral infection caused by HIV, hepatitis B virus, or hepatitis C virus;
  • Subjects with evidence of central nervous system leukemia before treatment initiation;
  • Women of childbearing potential who do not agree to use at least one reliable contraceptive method from Day 1 of the study until 90 days after the last dose of study medication; sexually active male subjects who do not agree to use contraceptive measures from Day 1 of the study until 90 days after the last dose of study medication; male subjects who do not agree to refrain from sperm donation from the start of study drug administration until at least 90 days after the last dose;
  • Subjects with epilepsy requiring pharmacotherapy, dementia, or other abnormal psychiatric conditions that impair the ability to understand or comply with the study protocol;
  • Presence of psychiatric disorders or cognitive impairment that prevents cooperation with treatment and follow-up; conditions limiting oral drug intake or gastrointestinal absorption.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VA-CIG
Patients are treated with VA-CIG chemotherapy regimen.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite complete response rate (CR+CRi)
Time Frame: At the end of Cycle 1 (each cycle is 28 days)

CR is defined as: following two cycles of induction therapy, a blast count of < 5% in the bone marrow, absence of Auer rods, no evidence of extramedullary leukemia, and peripheral blood absolute neutrophil count (ANC) and platelet count of > 1×10⁹/L and > 100×10⁹/L, respectively.

CRi is defined as: fulfilling all criteria for CR, except for a persistent absolute neutrophil count (ANC) < 1×10⁹/L or a persistent platelet count < 100×10⁹/L.
At the end of Cycle 1 (each cycle is 28 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Start of treatment to 2 weeks after end of treatment
Number of subjects with each adverse event.
Start of treatment to 2 weeks after end of treatment
MRD remission rate
Time Frame: At the end of Cycle 1 (each cycle is 28 days)
Defined as: the number of patients who achieved MRD-negative status after induction therapy / the total number of patients who underwent MRD testing at that time point × 100%; MRD-negative is defined as an MRD level < 10-⁴ in bone marrow samples;
At the end of Cycle 1 (each cycle is 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing 302 Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AML_VACIG_2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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