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Acute Myeloid Leukemia (AML)Phase 4NCT05144243

Study to Assess Adverse Events and Change in Disease State of Oral Venetoclax in Combination With Subcutaneous (SC) Azacitidine in Newly Diagnosed Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Chemotherapy in China

A Phase 4 study testing Venetoclax and Azacitidine in people with Acute Myeloid Leukemia (AML), run by AbbVie at 18 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Acute myeloid leukemia (AML) is one of the most aggressive blood cancers, with a very low survival rate and few options for participants who are unable to undergo intensive chemotherapy, the current standard of care. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia (AML)
What is being tested?
Venetoclax and Azacitidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
18 sitesChina
Study dates
6 Jan 2022to Mar 2026
Phase
Phase 4
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmation of Acute myeloid leukemia (AML) diagnosis by World Health Organization (WHO) criteria, have a projected life expectancy of at least 12 weeks, previously untreated, and ineligible for treatment with intensive chemotherapy.
  • Participant must be considered ineligible for induction therapy defined by the following:
  • >= 75 years of age
  • >=18 to 74 years of age with at least one of the following comorbidities:
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3.
  • Cardiac history of congestive heart failure requiring treatment or ejection fraction <= 50% or chronic stable angina.
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  • Diffusing capacity of the lung for carbon monoxide (DLCO) <= 65% or forced expiratory volume during the first second (FEV1) <= 65%.
  • Creatinine clearance >= 30 mL/min to < 45 mL/min.
  • Moderate hepatic impairment with total bilirubin > 1.5 to <= 3.0 × upper limit of normal (ULN).
  • Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy.
  • Must meet the laboratory requirements per the protocol.
  • Must have an ECOG performance status of:
  • 0 to 2 for subject ≥ 75 year of age; or
  • 0 to 3 for subject ≥ 18 to 74 years of age.
  • Female participant must not be pregnant or breastfeeding and is not considering becoming pregnant or donating eggs during the study or for approximately six months after the last dose of study drug.
  • Female participants of childbearing potential must agree to use at least 1 protocol-specified method of birth control and male participants, if sexually active with female partner(s) of childbearing potential, must agree to practice the protocol-specified contraception.

Who cannot join

  • History of any malignancies within 2 years prior to study entry with exception noted in the protocol.
  • Have received any investigational drug 30 days prior to the first dose of study drug.
  • Have received strong and/or moderate CYP3A inducers within 7 days prior to initiation of study treatment.
  • Must not have received treatment with the following:
  • An hypomethylating agent (HMA), venetoclax, and/or any chemotherapeutic agent for myelodysplastic syndrome (MDS).
  • Prior therapy or experimental therapies for MDS or Acute myeloid leukemia (AML).
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  • Current participation in another research or observational study.
  • Myeloproliferative neoplasm including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia with or without BCR-ABL1 translocation, and AML with BCR-ABL1 translocation.
  • Participant has acute promyelocytic leukemia.
  • Participant has known active central nervous system (CNS) involvement with AML.
  • Participant has a history of malabsorption syndrome or other condition that precludes enteral route of administration.
  • Participant has known HIV infection (due to potential drug-drug interactions between antiretroviral medications and venetoclax). HIV testing will be performed at Screening, only if required per local guidelines or institutional standards.
  • Active hepatitis B virus (HBV) and/or hepatitis C virus (HCV) with high viral titers. Participants with HBV inactive carrier status and/or HCV with low viral titers on antivirals (non-exclusionary medications) are eligible.
  • Participant has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Starfruit within 3 days prior to the initiation of study treatment.
  • Participant has chronic respiratory disease that requires continuous oxygen, or significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or any other medical condition or known hypersensitivity to any of the study medications including excipients of azacitidine that in the opinion of the investigator would adversely affect his/her participating in this study.
  • Participant exhibits evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial or fungal).

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

China18 sites

  • Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 233179

    Beijing, Beijing Municipality, 100730

  • Peking University International Hospital /ID# 232254

    Beijing, Beijing Municipality, 102206

  • Sun Yat-Sen University Cancer Center /ID# 231793

    Guangzhou, Guangdong, 510060

  • Zhujiang Hospital of Southern Medical University /ID# 231792

    Guangzhou, Guangdong, 510280

  • Guangdong Second Provincial General Hospital /ID# 232059

    Guangzhou, Guangdong, 510310

  • Nanfang Hospital of Southern Medical University /ID# 231938

    Guangzhou, Guangdong, 510515

  • Duplicate_The Affiliated Hospital of Guizhou Medical University /ID# 232465

    Guiyang, 550002

  • The First Affiliated Hospital of Nanchang University /ID# 231442

    Nanchang, Jiangxi, 330006

  • Shenzhen Second People's Hospital /ID# 231444

    Shenzhen, Guangdong, 518039

  • The First Affiliated Hospital of Soochow University /ID# 232418

    Suzhou, Jiangsu, 215006

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 232253

    Tianjin, Tianjin Municipality, 300020

  • The First Affiliated Hospital of Wenzhou Medical University /ID# 233704

    Wenzhou, Zhejiang, 325000

  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 233178

    Wuhan, Hubei, 430022

  • Xiangyang Central Hospital /ID# 232452

    Xiangyang, Hubei, 441106

  • Qinghai University Affiliated Hospital /ID# 232419

    Xining, Qinghai, 810001

  • The Second People's Hospital of Yibin /ID# 233180

    Yibin, Sichuan, 644099

  • People's Hospital of Henan Province /ID# 232568

    Zhengzhou, Henan, 450003

  • Henan Cancer Hospital /ID# 231940

    Zhengzhou, Henan, 450008

Other trials in China

About this study

Official title: A Phase 4 Study of Venetoclax in Combination With Azacitidine in Newly Diagnosed Subjects With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy in China

Acute myeloid leukemia (AML) is one of the most aggressive blood cancers, with a very low survival rate and few options for participants who are unable to undergo intensive chemotherapy, the current standard of care. This study is to evaluate how safe the combination of azacitidine and venetoclax is and how effective the combination of azacitidine and venetoclax is in adult participants with acute myeloid leukemia (AML), in China. Adverse events and change in disease state will be assessed.

The combination of azacitidine and venetoclax is being evaluated in the treatment of acute myeloid leukemia (AML). Participants will receive azacitidine with increasing doses of venetoclax. Adult participants with a diagnosis of AML will be enrolled. Around 40 participants will be enrolled in the study in approximately 30 sites in China.

Read more

At cycle 1 during ramp-up period, participants will receive venetoclax oral tablets once daily in increasing doses until the study dose is achieved on day 3. Then ventoclax oral tablets will continue once daily thereafter. Azacitidine will be given by subcutaneous injection (SC) for 7 days beginning on Day 1 of each 28-day cycle.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.

Being tested
Venetoclax, Azacitidine
Keywords
Acute Myeloid Leukemia, AML, Venetoclax, Venclexta, Azacitidine, Treatment Naïve AML, Untreated AML
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.

  • VenetoclaxDrug

    Also called ABT-199, GDC-0199, Venclexta

    Tablet: Oral

  • AzacitidineDrug

    Subcutaneous Injection (SC)

Study groups in NCT05144243
Study groupRoleWhat they receive
Venetoclax in Combination with AzacitidineExperimentalParticipants will receive oral tablet venetoclax dose ramp-up only in Cycle 1 Days 1-3 until target dose is reached. Particpants will then receive oral tablet venetoclax at the target dose every day (QD) on Cycle Days 1 - 28 plus Azacitidine through subcutaneous injection (SC) QD on Cycle Days 1 - 7 (28-day cycle).
Receives: Drug: Venetoclax; Drug: Azacitidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug. The investigator assesses the relationship of each event to the use of study.

    Measured: Up to Approximately 19 Months

  2. Number of Laboratory Abnormalities from Clinical Laboratory Values (Hematology and Chemistry)

    Number of Laboratory abnormalities from clinical laboratory values (hematology and chemistry).

    Measured: Up to Approximately 19 Months

Secondary outcomes (2)

  1. Percentage of Participants with Composite Complete Remission (CR [Complete Remission] + CRi [Complete Remission with Incomplete Blood Count Recovery]) Based on the Modified International Working Group (IWG) Criteria for Acute Myeloid Leukemia (AML)

    CR + CRi is defined as achieving a CR or CRi at any time point during the study prior to the start of post-treatment anti-AML therapies per the modified IWG criteria for AML. CR is defined as absolute neutrophil count (ANC) > 10^3/μL, platelets > 10^5/μL, red cell transfusion independence, and bone marrow with < 5% blasts. Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CRi is defined as all of the criteria for CR except for residual neutropenia <= 10^3/μL (1000/μL) or thrombocytopenia <= 10^5/μL (100,000/μL). Red blood cell (RBC) transfusion dependence is also defined as CRi.

    Measured: Up to Approximately 19 Months

  2. Percentage of Participants with CR based on the modified IWG criteria for AML

    CR is defined as absolute neutrophil count (ANC) > 10^3/μL, platelets > 10^5/μL, red cell transfusion independence, and bone marrow with < 5% blasts. Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease.

    Measured: Up to Approximately 19 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2021
  2. Study start6 Jan 2022
  3. Primary completionMar 2026 (estimated)
  4. Study completionMar 2026 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05144243
Sponsor's protocol ID
M21-569
Status last verified
Aug 2025
First submitted
22 Nov 2021
Last updated
12 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Venetoclax and Azacitidine in people with Acute Myeloid Leukemia (AML), run by AbbVie at 18 sites 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 16 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: Up to Approximately 19 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05144243.

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 12 Aug 2025.

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