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

NCT05144243 | Active Not Recruiting Phase 4

• 1 other identifier: M21-569
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 18

Brief 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. 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. 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.

Conditions

Acute Myeloid Leukemia (AML)

Keywords

Acute Myeloid Leukemia; AML; Venetoclax; Venclexta; Azacitidine; Treatment Naïve AML; Untreated AML

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to Approximately 19 Months

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

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

  Up to Approximately 19 Months

Secondary Outcomes (2)

• 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)

  Up to Approximately 19 Months

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

  Up to Approximately 19 Months

Study Arms (1)

Venetoclax in Combination with Azacitidine

EXPERIMENTAL

Participants 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).

Drug: Venetoclax; Drug: Azacitidine

Interventions

Venetoclax DRUG

Tablet: Oral

Also known as: ABT-199, GDC-0199, Venclexta

Venetoclax in Combination with Azacitidine

Azacitidine DRUG

Subcutaneous Injection (SC)

Venetoclax in Combination with Azacitidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:
• to 2 for subject ≥ 75 year of age; or
• 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.

You may not qualify if:

• 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).
• 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.
• 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).

Sponsors & Collaborators

• AbbVie: lead
• Genentech, Inc.: collaborator

Study Sites (18)

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

Beijing, Beijing Municipality, 100730, China

Location

Peking University International Hospital /ID# 232254

Beijing, Beijing Municipality, 102206, China

Location

Sun Yat-Sen University Cancer Center /ID# 231793

Guangzhou, Guangdong, 510060, China

Location

Zhujiang Hospital of Southern Medical University /ID# 231792

Guangzhou, Guangdong, 510280, China

Location

Guangdong Second Provincial General Hospital /ID# 232059

Guangzhou, Guangdong, 510310, China

Location

Nanfang Hospital of Southern Medical University /ID# 231938

Guangzhou, Guangdong, 510515, China

Location

Shenzhen Second People's Hospital /ID# 231444

Shenzhen, Guangdong, 518039, China

Location

People's Hospital of Henan Province /ID# 232568

Zhengzhou, Henan, 450003, China

Location

Henan Cancer Hospital /ID# 231940

Zhengzhou, Henan, 450008, China

Location

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

Wuhan, Hubei, 430022, China

Location

Xiangyang Central Hospital /ID# 232452

Xiangyang, Hubei, 441106, China

Location

The First Affiliated Hospital of Soochow University /ID# 232418

Suzhou, Jiangsu, 215006, China

Location

The First Affiliated Hospital of Nanchang University /ID# 231442

Nanchang, Jiangxi, 330006, China

Location

Qinghai University Affiliated Hospital /ID# 232419

Xining, Qinghai, 810001, China

Location

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

Yibin, Sichuan, 644099, China

Location

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

Tianjin, Tianjin Municipality, 300020, China

Location

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

Wenzhou, Zhejiang, 325000, China

Location

Duplicate_The Affiliated Hospital of Guizhou Medical University /ID# 232465

Guiyang, 550002, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax; Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 3, 2021
• Study Start: January 6, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

CN (18)