AML (Acute Myeloid Leukemia)Phase 2NCT07514832
VA-CIG Regimen for Previously Untreated Acute Myeloid Leukemia: A Multicenter Prospective Single-Arm Trial
A Phase 2 study testing Venetoclax, Azacitidine, Cytarabine, Idarubicin, G-CSF in people with AML (Acute Myeloid Leukemia), run by Beijing 302 Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- AML (Acute Myeloid Leukemia)
- What is being tested?
- Venetoclax, Azacitidine, Cytarabine, Idarubicin, G-CSF
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2026to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing
Lei Xu, 86-01066947174, xulei800@hotmail.com
About this study
Official title: 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.
- Conditions
- AML (Acute Myeloid Leukemia)
- Being tested
- Venetoclax, Azacitidine, Cytarabine, Idarubicin, G-CSF
- Keywords
- AML, Venetoclax, chemotherapy, BCL2 inhibitor
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venetoclax, Azacitidine, Cytarabine, Idarubicin, G-CSFDrug
- 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
| Study group | Role | What they receive |
|---|---|---|
| VA-CIG | Experimental | Patients are treated with VA-CIG chemotherapy regimen. Receives: Drug: Venetoclax, Azacitidine, Cytarabine, Idarubicin, G-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite complete response rate (CR+CRi)
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.
Measured: At the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes (2)
MRD remission rate
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;
Measured: At the end of Cycle 1 (each cycle is 28 days)
Adverse events
Number of subjects with each adverse event.
Measured: Start of treatment to 2 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML (Acute Myeloid Leukemia)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-Ning Gao, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514832
- Sponsor's protocol ID
- AML_VACIG_2026
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07514832
- Acronym / sponsor ID
- AML_VACIG_2026
- Conditions
- AML (Acute Myeloid Leukemia)
- Keywords
- AML, Venetoclax, chemotherapy, BCL2 inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VA-CIG | Experimental | Drug: Venetoclax, Azacitidine, Cytarabine, Idarubicin, G-CSFPatients are treated with VA-CIG chemotherapy regimen. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | VA-CIG |
Primary outcome
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.
2 secondary outcomes
MRD remission rate
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Adverse events
Time frame: Start of treatment to 2 weeks after end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Venetoclax, Azacitidine, Cytarabine, Idarubicin, G-CSF in people with AML (Acute Myeloid Leukemia), run by Beijing 302 Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Gao Xiaoning, Chief Physician, Professor (86+01066947169, gaoxn@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite complete response rate (CR+CRi) (time frame: At the end of Cycle 1 (each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.