ClinicalTrials.gg
RecruitingNCT07514832Updated Apr 7, 2026

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

A Phase 2 interventional study of Venetoclax, Azacitidine, Cytarabine, Idarubicin, G-CSF in AML (Acute Myeloid Leukemia), sponsored by Beijing 302 Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-07.

Sponsored by Beijing 302 Hospital · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 202 studies testing venetoclax in Leukemia, Myeloid, Acute — 116 open to participants now, 144 under way, 21 of them phase 3. venetoclax · Leukemia, Myeloid, Acute.

Planned enrollment
118th of 202
48 · median 57
Started
2026
with 27 others
Phase 2
89 of 202
57 open now
Primary completion
2028-04
later than 97 of 143 live
Registered
191st of 202
by date
Lead sponsor
4 of 202
Beijing 302 Hospital

Among the 202 studies testing venetoclax in Leukemia, Myeloid, Acute, this one is the 118th largest by planned enrollment, is one of 28 that started in 2026, is one of 89 in phase 2, reaches primary completion later than 97 of the 143 other live ones, and was the 191st registered.

Leukemia, Myeloid, Acute

3,668 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.

Browse Leukemia, Myeloid, Acute studies →

Open to participants now

116 of the 202 studies testing venetoclax in Leukemia, Myeloid, Acute are open now, in 12 countries. Recruiting first, the newest first:

110 more — sign in →

By country, each count listing its studies:

All 116 open studies →

About venetoclax

venetoclax: first FDA approval 2016 (VENCLEXTA), first EMA approval 2016. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 625 Leukemia, Myeloid, Acute studies recruiting now, 363 (58%) set no upper age limit and 222 (36%) stop at 75 or younger; 145 take children under 18; 29 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 202 studies testing venetoclax in Leukemia, Myeloid, Acute, or all of them as a file.
02

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.

03

Conditions studied

  • AML (Acute Myeloid Leukemia)

Keywords

  • AML
  • Venetoclax
  • chemotherapy
  • BCL2 inhibitor
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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);
  • (ECOG) performance status score ≤ 2;
  • Serum creatinine ≤ 2.0 × (ULN), or > 40 mL/min calculated by the Cockcroft-Gault formula for (GFR);
  • Total ≤ 2 × ULN, and (AST) or alanine aminotransferase (ALT) ≤ 3 × ULN;
  • (LVEF) ≥ 45%, or LVEF measured by echocardiography (ECHO) within the normal range;
  • Expected survival > 3 months.

Exclusion criteria

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 to any component of the medicinal products;
  • History of other concurrent 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 , virus, or virus;
  • Subjects with evidence of central nervous system leukemia before treatment initiation;
  • Women of who do not agree to use at least one reliable 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.
Terms in these criteria, in plain language(15)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    VA-CIG

    Patients are treated with VA-CIG chemotherapy regimen.

    Drug: Venetoclax, Azacitidine, Cytarabine, Idarubicin, G-CSF

Interventions

  • DrugVenetoclax, Azacitidine, Cytarabine, Idarubicin, G-CSF

    Drug pages: Venetoclax · Azacitidine · Cytarabine · Idarubicin · Granulocyte Colony-Stimulating Factor

    * 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At the end of Cycle 1 (each cycle is 28 days)

Secondary outcomes

  1. 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;

    Time frame: At the end of Cycle 1 (each cycle is 28 days)

  2. Adverse events

    Number of subjects with each adverse event.

    Time frame: Start of treatment to 2 weeks after end of treatment

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2026; primary completion for Apr 2028, 23 months later.

Of 386 non-industry phase 2 interventional studies under Leukemia, Myeloid, Acute, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 108. This study's planned 23 months is below that.

Counting every sponsor, half of 443 studies reached it within 60 months; a quarter within 38 and three quarters within 104.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 31, 2026
First posted
Apr 7, 2026
StartEst.
Apr 15, 2026
Primary completionEst.
Apr 1, 2028
CompletionEst.
Dec 31, 2028
Last update
Apr 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07514832
Lead sponsor
Beijing 302 Hospital
Responsible party
Xiao-Ning Gao (Chief Physician, Professor, Beijing 302 Hospital) — Principal investigator
First posted
Apr 7, 2026
Start date
Apr 15, 2026 (estimated)
Primary completion
Apr 1, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Apr 7, 2026

Study contacts

Dr. Gao Xiaoning, Chief Physician, Professor
Contact
gaoxn@263.net
86+01066947169

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Venetoclax · Azacitidine · Cytarabine · Idarubicin · Granulocyte Colony-Stimulating Factor

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