Acute Myeloid LeukemiaPhase 4NCT07044687
Study to Assess Adverse Events and Change in Disease Activity of Oral Venetoclax in Combination With Subcutaneous (SC) or Intravenous (IV) Azacitidine in Newly Diagnosed Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Standard Induction Therapy in India
A Phase 4 study testing Venetoclax and Azacitidine in people with Acute Myeloid Leukemia, run by AbbVie at 14 sites in India.
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 standard induction therapy, 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
- What is being tested?
- Venetoclax and Azacitidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 14 sitesIndia
- Study dates
- 24 Jul 2025to Nov 2027
- 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 2016 World Health Organization (WHO) criteria, previously untreated, and ineligible for treatment with intensive chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of:
- 0 to 2 for subject ≥ 75 years of age.
- 0 to 3 for subject ≥ 18 to 74 years of age.
Who cannot join
- History of any malignancy within 2 years prior to study entry with exception to those noted in the protocol.
- Have received any investigational drug 30 days prior to the first dose of study drug and have received strong CYP3A inducers within 7 days prior to the initiation of study treatment.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
India14 sites, 11 recruiting
- Completed
Healthcare Global Enterprises Limited (HCGEL) /ID# 272071
Bengaluru, Karnataka, 560027
- Recruiting
Mazumdar Shaw Medical Center /ID# 270677
Bengaluru, Karnataka, 560099
- Recruiting
All India Institute Of Medical Sciences - Bhubaneswar /ID# 274879
Bhubaneswar, Odisha, 751019
- Recruiting
Apollo Cancer Centre /ID# 268780
Chennai, Tamil Nadu, 600035
- Recruiting
Cancer Institute (Wia) /ID# 268695
Chennai, Tamil Nadu, 600036
- Completed
Fortis Memorial Research Institute /ID# 268697
Gurgaon, Haryana, 122002
- Recruiting
Basavatarakam Indo American Cancer Hospital & Research Institute /ID# 268692
Hyderabad, Telangana, 500034
- Recruiting
Tata Memorial Hospital - Mumbai /ID# 269177
Mumbai, Maharashtra, 400012
- Recruiting
All India Institute Of Medical Sciences - New Delhi /ID# 268357
New Delhi, National Capital Territory of Delhi, 110029
- Completed
Rajiv Gandhi Cancer Institute And Research Centre /ID# 268293
New Delhi, National Capital Territory of Delhi, 110085
- Recruiting
LMMF's Deenanath Mangeshkar Hospital & Research Center /ID# 268781
Pune, Maharashtra, 411004
- Recruiting
Sahyadri Super Speciality Hospital /ID# 272074
Pune, Maharashtra, 411044
- Recruiting
Regional Cancer Centre /ID# 268785
Thiruvananthapuram, Kerala, 695011
- Recruiting
Christian Medical College Vellore /ID# 279587
Vellore, Tamil Nadu, 632004
About this study
Official title: A Phase 4 Study of Venetoclax in Combination With Azacitidine in Indian Subjects With Newly Diagnosed Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy
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 standard induction therapy, the current standard of care. This study will assess the change in disease activity and adverse events in adult participants with acute myeloid leukemia (AML) being treated with of the combination of azacitidine and venetoclax, in India.
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. Around 40 adult participants with a diagnosis of AML will be enrolled in the study at approximately 15 sites in India.
Read more
Participants will receive venetoclax oral tablets once daily in increasing doses until the study dose is achieved. Then ventoclax oral tablets will continue once daily thereafter. Azacitidine will be given by subcutaneous (SC) or intravenous (IV) injection on Days 1-7 of each cycle. The total study duration is approximately 29 months.
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
- 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
Oral Tablet
AzacitidineDrug
Subcutaneous (SC) Injection
AzacitidineDrug
Intravenous (IV) Injection
| Study group | Role | What they receive |
|---|---|---|
| Venetoclax in Combination with Azacitidine | Experimental | Participants will receive venetoclax once daily in increasing doses until the study dose is achieved. Then ventoclaxwill continue once daily thereafter. Participants will receive azacitidine on Day 1-7 of each cycle. The total study duration is approximately 29 months. Receives: Drug: Venetoclax; Drug: Azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Treatment Emergent Adverse Events (TEAE)s
TEAEs defined as any adverse event (AE) with the onset after the first dose of study drug until 30 days after the last dose of the study drug.
Measured: Up to Approximately 29 Months
Percentage of Participants with Post-Baseline Laboratory Abnormalities
Laboratory abnormalities are defined based on the shifts from baseline to postbaseline laboratory values will be summarized using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
Measured: Up to Approximately 29 Months
Secondary outcomes (4)
Composite Complete Remission (CRc)
(CRc) is defined as Complete remission (CR) or complete remission with incomplete marrow recovery (CRi) per the modified International Working Group (IWG) response criteria for AML in participants who received venetoclax and azacitidine combination study treatment.
Measured: Up to Approximately 29 Months
Composite Complete Remission (CRc) by initiation of Cycle 2
(CRc) is defined as Complete remission (CR) or complete remission with incomplete marrow recovery (CRi) per the modified International Working Group (IWG) response criteria for AML in participants who received venetoclax and azacitidine combination study treatment.
Measured: Up to Approximately 1 Month
Complete Remission
CR is defined as the modified IWG response criteria for AML in participants who received venetoclax and azacitidine combination study treatment.
Measured: Up to Approximately 29 Months
Overall Survival (OS)
OS is defined as the time measured from randomization until death from any cause.
Measured: Up to Approximately 29 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start24 Jul 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044687
- Sponsor's protocol ID
- M23-826
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2025
- Last updated
- 11 Sep 2026
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4 Study of Venetoclax in Combination With Azacitidine in Indian Subjects With Newly Diagnosed Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy
- ClinicalTrials.gov ID
- NCT07044687
- Acronym / sponsor ID
- M23-826
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, AML, Venetoclax, Venclexta, Azacitidine, Treatment Naïve AML, Untreated AML
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 1 Jul 2025 (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.
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 standard induction therapy, the current standard of care. This study will assess the change in disease activity and adverse events in adult participants with acute myeloid leukemia (AML) being treated with of the combination of azacitidine and venetoclax, in India.
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. Around 40 adult participants with a diagnosis of AML will be enrolled in the study at approximately 15 sites in India.
Participants will receive venetoclax oral tablets once daily in increasing doses until the study dose is achieved. Then ventoclax oral tablets will continue once daily thereafter. Azacitidine will be given by subcutaneous (SC) or intravenous (IV) injection on Days 1-7 of each cycle. The total study duration is approximately 29 months.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venetoclax in Combination with Azacitidine | Experimental | Drug: Venetoclax, Drug: AzacitidineParticipants will receive venetoclax once daily in increasing doses until the study dose is achieved. Then ventoclaxwill continue once daily thereafter. Participants will receive azacitidine on Day 1-7 of each cycle. The total study duration is approximately 29 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmation of acute myeloid leukemia (AML) diagnosis by 2016 World Health Organization (WHO) criteria, previously untreated, and ineligible for treatment with intensive chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of:
Key exclusion criteria (2 listed)
- History of any malignancy within 2 years prior to study entry with exception to those noted in the protocol.
- Have received any investigational drug 30 days prior to the first dose of study drug and have received strong CYP3A inducers within 7 days prior to the initiation of study treatment.
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 |
|---|---|---|
| VenetoclaxOral Tablet | Drug | Venetoclax in Combination with Azacitidine |
| AzacitidineSubcutaneous (SC) Injection | Drug | Venetoclax in Combination with Azacitidine |
| AzacitidineIntravenous (IV) Injection | Drug | Venetoclax in Combination with Azacitidine |
Primary outcome
Percentage of Participants with Treatment Emergent Adverse Events (TEAE)s
Time frame: Up to Approximately 29 Months
TEAEs defined as any adverse event (AE) with the onset after the first dose of study drug until 30 days after the last dose of the study drug.
Percentage of Participants with Post-Baseline Laboratory Abnormalities
Time frame: Up to Approximately 29 Months
Laboratory abnormalities are defined based on the shifts from baseline to postbaseline laboratory values will be summarized using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
4 secondary outcomes
Composite Complete Remission (CRc)
Time frame: Up to Approximately 29 Months
Composite Complete Remission (CRc) by initiation of Cycle 2
Time frame: Up to Approximately 1 Month
Complete Remission
Time frame: Up to Approximately 29 Months
Overall Survival (OS)
Time frame: Up to Approximately 29 Months
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 11 Sep 2026.
- Individual participant dataSharing planned: 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.
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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.
ABBVIE INC. study director
AbbVie
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Venetoclax and Azacitidine in people with Acute Myeloid Leukemia, run by AbbVie at 14 sites in India.
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 4 inclusion and 2 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 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in India. 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?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Treatment Emergent Adverse Events (TEAE)s (time frame: Up to Approximately 29 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?
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 11 Sep 2026.