Acute Myeloid LeukemiaPhase 1NCT03844815
Study of Venetoclax in Combination With Decitabine in Subjects With Acute Myeloid Leukemia
A Phase 1 study testing Decitabine and Venetoclax in people with Acute Myeloid Leukemia, run by University of Chicago at 1 site in United States.
Trial summary
The main purpose of this study is to learn about the safety and tolerability of an experimental drug, Venetoclax, when it is given along with Decitabine in subjects diagnosed with acute myeloid leukemia (AML). 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?
- Decitabine and Venetoclax
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2019to 10 Dec 2027
- Phase
- Phase 1
- 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
- Phase 1: Dose Escalation Phase
- High risk AML, including any of the following:
- Relapsed or refractory disease
- TP53 mutant AML
- Adverse risk cytogenetics including any of the following: 3 or more abnormalities; deletions involving chromosomes 5, 7, or 17; abnormalities in chromosome 11 involving MLL; t(6;9); inv(3) or t(3;3)
- ECOG performance status 0-2
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- Age 18 years or older
- Adequate organ function as defined by all of the following:
- Creatinine clearance ≥30 mL/min, determined by the Cockroft-Gault formula, or measured by a 24 hour urine collection
- AST and ALT ≤3 x ULN and bilirubin ≤1.5 x ULN (unless considered due to Gilbert's syndrome or of non-hepatic origin i.e. leukemic involvement).
- Patients must be at least 2 weeks from major surgery, radiation therapy, or participation in other investigational trials, and must have recovered from clinically significant toxicities related to these prior treatments.
- Patients must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the i initiation of any screening or study specific procedures.
- Female patients of childbearing potential must have negative results for a pregnancy test
- Patients must be willing to use appropriate contraception
- Phase 2: Dose Expansion Phase During the Phase 2 portion of the study, the subject population will be limited to patients with previously untreated AML with a mutation in TP53. All other inclusion criteria described above will apply.
Who cannot join
- Key exclusion criteria (apply to both Phase 1 and Phase 2 portions of the study):
- Concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in this protocol
- Patients suitable for and willing to receive intensive induction chemotherapy
- Use of investigational agents and/or anticancer therapy within 2 weeks of study entry (with the exception of hydroxyurea, which is permitted before and during Cycle 1 of therapy until D10, at the discretion of the investigator)
- Prior treatment with venetoclax, decitabine, or azacitidine
- Diagnosis of acute promyelocytic leukemia
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- Pregnant or breastfeeding patients
- Patient known to be positive for HIV
- Known CNS involvement with AML
- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
- Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
- Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate.
- An active second cancer that requires treatment within 6 months of study entry
- Cardiac history including the following:
- History of CHF requiring treatment or Ejection Fraction ≤ 50%
- Subject has a cardiovascular disability status of New York Heart Association
- Class > 2, defined as:
- Cardiac disease in which patients are comfortable at rest but ordinary physical activity ii. Results in fatigue, palpitations, dyspnea, or anginal pain c. Chronic stable angina
- Treatment with any of the following within 7 days prior to the first dose of study drug:
- Steroid therapy for anti-neoplastic intent
- Moderate or strong cytochrome P450 3A (CYP3A) inducers
- Administration or consumption of any of the following within 3 days prior to the first dose of study drug:
- Grapefruit or grapefruit products
- Seville oranges (including marmalade containing Seville oranges)
- Star fruit
Trial locations and contacts
1 site in 1 country.
United States1 site
University Of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
About this study
Official title: Phase 1 Study of Venetoclax in Combination With Decitabine 10-Day Regimen in Subjects With Acute Myeloid Leukemia
The main purpose of this study is to learn about the safety and tolerability of an experimental drug, Venetoclax, when it is given along with Decitabine in subjects diagnosed with acute myeloid leukemia (AML).
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Decitabine, Venetoclax
- 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.
DecitabineDrug
Decitabine will be administered intravenously at a dose of 20mg per day for 10 days during Cycle 1 (28 day cycle)
Decitabine will be administered intravenously at a dose of 20mg per day for 10 days of Cycle 2 (28 day cycle).
Decitabine will be administered intravenously at a dose of 20mg per day for 5 days of each 28 day maintenance cycle
VenetoclaxDrug
Venetoclax administered orally on days 1-21 of cycle 1, cycle 2 and maintenance (28 day cycles). Dose levels will be assigned at time of enrollment anywhere from 100mg-400mg. Dose escalation will follow the 3+3 study design.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Cycle 1 of Treatment will be Decitabine days 1-10 plus Venetoclax ramp up on days 1-3 followed by Venetoclax target dose on days 4-21
Cycle 2 of Treatment will be Decitabine days 1-10 plus Venetcolax target dose days 1-21
During maintenance Decitabine on days 1-5 plus Venetoclax days 1-21 Receives: Drug: Decitabine; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of dose limiting toxicity (DLT)
Determine the rate of subjects who experience a dose limiting toxicity and the maximum tolerable dose
Measured: 24 months
Secondary outcomes (2)
Levels of toxicity with combination regimen
Levels of toxicity experienced with the combination regimen will be reported using data summaries of adverse events, dose limiting toxicity and other safety parameters.
Measured: 24 months
Assessment of Overall Survival
Survival will be measured in months from the date of subject enrollment to the date of death.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start18 Nov 2019
- Primary completion10 Dec 2027 (estimated)
- Study completion10 Dec 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 University of ChicagoThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Sponsor
- Investigators
- Olatoyosi Odenike, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844815
- Sponsor's protocol ID
- IRB18-1498
- Status last verified
- Mar 2026
- First submitted
- 14 Feb 2019
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Venetoclax in Combination With Decitabine 10-Day Regimen in Subjects With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT03844815
- Acronym / sponsor ID
- IRB18-1498
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 10 Dec 2027 (estimated)
- Study completion
- 10 Dec 2027 (estimated)
- First posted
- 18 Feb 2019 (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.
The main purpose of this study is to learn about the safety and tolerability of an experimental drug, Venetoclax, when it is given along with Decitabine in subjects diagnosed with acute myeloid leukemia (AML).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Decitabine, Drug: VenetoclaxCycle 1 of Treatment will be Decitabine days 1-10 plus Venetoclax ramp up on days 1-3 followed by Venetoclax target dose on days 4-21 Cycle 2 of Treatment will be Decitabine days 1-10 plus Venetcolax target dose days 1-21 During maintenance Decitabine on days 1-5 plus Venetoclax days 1-21 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Phase 1: Dose Escalation Phase
- Phase 2: Dose Expansion Phase During the Phase 2 portion of the study, the subject population will be limited to patients with previously untreated AML with a mutation in TP53. All other inclusion criteria described above will apply.
Key exclusion criteria (25 listed)
- Key exclusion criteria (apply to both Phase 1 and Phase 2 portions of the study):
- Concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in this protocol
- Patients suitable for and willing to receive intensive induction chemotherapy
- Use of investigational agents and/or anticancer therapy within 2 weeks of study entry (with the exception of hydroxyurea, which is permitted before and during Cycle 1 of therapy until D10, at the discretion of the investigator)
- Prior treatment with venetoclax, decitabine, or azacitidine
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 |
|---|---|---|
| DecitabineDecitabine will be administered intravenously at a dose of 20mg per day for 10 days during Cycle 1 (28 day cycle) Decitabine will be administered intravenously at a dose of 20mg per day for 10 days of Cycle 2 (28 day cycle). Decitabine will be administered intravenously at a dose of 20mg per day for 5 days of each 28 day maintenance cycle | Drug | Treatment |
| VenetoclaxVenetoclax administered orally on days 1-21 of cycle 1, cycle 2 and maintenance (28 day cycles). Dose levels will be assigned at time of enrollment anywhere from 100mg-400mg. Dose escalation will follow the 3+3 study design. | Drug | Treatment |
Primary outcome
The rate of dose limiting toxicity (DLT)
Time frame: 24 months
Determine the rate of subjects who experience a dose limiting toxicity and the maximum tolerable dose
2 secondary outcomes
Levels of toxicity with combination regimen
Time frame: 24 months
Assessment of Overall Survival
Time frame: 24 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 4 Mar 2026.
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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. This study is not recruiting at the moment.
Olatoyosi Odenike, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Decitabine and Venetoclax in people with Acute Myeloid Leukemia, run by University of Chicago at 1 site in United States.
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 15 inclusion and 25 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 4 Mar 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The rate of dose limiting toxicity (DLT) (time frame: 24 months). 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 4 Mar 2026.