Acute Myeloid Leukaemia (AML)Phase 2NCT07867626
Phase II De-Escalation Study of Metronomic Decitabine/Cedazuridine Plus Venetoclax in AML
A Phase 2 study testing Venetoclax, Decitabine/Cedaruridine and decitabine/cedazuridine in people with Acute Myeloid Leukaemia (AML), run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
To evaluate the 12-month relapse free survival with weekly Decitabine/cedazuridine plus Venetoclax in AML maintenance after achieving composite CR (CR, CRi, CRh) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukaemia (AML)
- What is being tested?
- Venetoclax, Decitabine/Cedaruridine and decitabine/cedazuridine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2026to Dec 2029
- Phase
- Phase 2
- 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
- Newly diagnosed AML (WHO 2022 classification or ICC 2022 classification)
- Participants must be considered Ineligible for intensive induction defined by the following:
- Age 75 years or older, or
- Age 18 to 74 years with at least one of the following comorbidities:
- Severe cardiac disorder (eg, congestive heart failure requiring treatment, ejection fraction ≤50%, or chronic stable angina). ii) Severe pulmonary disorder (eg, DLCO ≤65% or FEV1 ≤65%). iii) Creatinine clearance ≥30 mL/min to <45 mL/min iv) Moderate hepatic impairment with total bilirubin >1.5 to ≤3.0 × upper limit of normal (ULN).
- Must have achieved CR,CRh, CRi, following induction with maximum 3 cycles of standard IV HMAs and venetoclax.
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- Able to provide informed consent
- Prior and concomitant hydroxyurea is permitted
- ECOG performance status 0 to 3
Who cannot join
- Progression or relapse after induction standard HMAs + Venetoclax therapy
- Pregnancy or breastfeeding
- Uncontrolled infection, active CNS disease, or concurrent malignancy requiring systemic therapy
- Inability to take oral medication or presence of malabsorption syndrome or any other uncontrolled gastrointestinal condition
- Candidate for intensive chemotherapy
- Uncontrolled infection, active CNS disease, or concurrent malignancy requiring systemic therapy
- Candidate for stem cell transplant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Rutgers Cancer Institute
New Brunswick, New Jersey, 08902
About this study
Official title: A Phase II De-Escalation Study of Metronomic Decitabine/Cedazuridine Plus Venetoclax in Acute Myeloid Leukemia Maintenance.
To evaluate the 12-month relapse free survival with weekly Decitabine/cedazuridine plus Venetoclax in AML maintenance after achieving composite CR (CR, CRi, CRh)
Read the detailed description
This is an open-label, phase II, safety-primary study evaluating metronomic maintenance with once-weekly Decitabine/cedazuridine plus once-weekly Ven in patients with AML who are in CR, CRh, CRi,following standard HMAs + Ven induction and are candidates for maintenance.The study uses a single starting regimen (Venetoclax 400 mg weekly) with a pre-specified Venetoclax dose-reduction step in the event of treatment-limiting toxicity (TLT), while maintaining weekly Decitabine/cedazuridine dosing.
- Conditions
- Acute Myeloid Leukaemia (AML)
- Being tested
- Venetoclax, Decitabine/Cedaruridine, decitabine/cedazuridine
- Keywords
- acute myeloid leukemia, Venetocalx, Decitabine/Cedazuridine
- 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.
Venetoclax, Decitabine/CedaruridineDrug
Patients who consent to the study will receive weekly Decitabine/Cedaruridine plus Venetoclax until intolerance or disease progression. Both Decitabine/Cedaruridine and Venetoclax are administered orally once on D1, 8, 15, 22 each
decitabine/cedazuridineDrug
Patients who consent to the study will receive weekly decitabine/cedazuridine plus Venetoclax until intolerance or disease progression. Venetoclax is administered orally once on D1, 8, 15, 22 each 28-day cycle with food and water. Decitabine/Cedazuridine is administered orally once on D1, D8, D15 D22 with empty stomach.
| Study group | Role | What they receive |
|---|---|---|
| Venetoclax Plus HMA: A New Standard of Care for AML | Experimental | Older AML patients have benefited from the advent of venetoclax + HMAs therapy, achieving higher remission rates and longer survival than previously possible. The next challenge is to sustain those remissions with a more acceptable toxicity profile and better quality of life. Building on landmark trials (VIALE-A) and emerging research on lower-dose strategies, we propose a phase 2 study of metronomic weekly Decitabine/cedazuridine plus venetoclax as maintenance therapy following initial composite CR response. This approach is grounded in strong biological rationale and preliminary clinical evidence suggesting feasibility and potential activity with improved tolerability. By transitioning patients to a maintenance phase of weekly low-dose therapy after maximum of 3 induction cycles of standard IV decitabine + venetoclax (to achieve CRi or better), we aim to evaluate whether remission can be maintained while minimizing toxicity and maximizing QOL. Receives: Drug: Venetoclax, Decitabine/Cedaruridine; Drug: decitabine/cedazuridine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
To evaluate the relapse free survival in patients with AML receiving metronomic maintenance therapy with weekly Decitabine/cedazuridine plus Venetoclax. RFS is measured from the date of first documented CR/CRi until the date of confirmed relapse or death from any cause, whichever occurs first.
Measured: 12 months
Secondary outcomes (2)
Secondary Outcome 1
To assess treatment delay defined as postponing treatment for more than 7 days or cancellation of treatment due to adverse effects caused by maintenance chemotherapy.
Measured: 8 days
Secondary Outcome 2
To determine the overall survival, defined as the number of days from the start of induction therapy to the date of death. Subjects that have not died will be censored at the last known date to be alive.
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 posted9 Oct 2026
- Study start30 Sep 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukaemia (AML)Studies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoyi Chen, MD, PhD, Rutgers, The State University of New Jersey
- Investigators
- Xiaoyi Chen, MD, PhD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867626
- Sponsor's protocol ID
- 022604
- Other IDs
- Pro2026001077
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II De-Escalation Study of Metronomic Decitabine/Cedazuridine Plus Venetoclax in Acute Myeloid Leukemia Maintenance.
- ClinicalTrials.gov ID
- NCT07867626
- Acronym / sponsor ID
- 022604
- Conditions
- Acute Myeloid Leukaemia (AML)
- Keywords
- acute myeloid leukemia, Venetocalx, Decitabine/Cedazuridine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 9 Oct 2026 (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.
To evaluate the 12-month relapse free survival with weekly Decitabine/cedazuridine plus Venetoclax in AML maintenance after achieving composite CR (CR, CRi, CRh)
Detailed description
This is an open-label, phase II, safety-primary study evaluating metronomic maintenance with once-weekly Decitabine/cedazuridine plus once-weekly Ven in patients with AML who are in CR, CRh, CRi,following standard HMAs + Ven induction and are candidates for maintenance.The study uses a single starting regimen (Venetoclax 400 mg weekly) with a pre-specified Venetoclax dose-reduction step in the event of treatment-limiting toxicity (TLT), while maintaining weekly Decitabine/cedazuridine dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venetoclax Plus HMA: A New Standard of Care for AML | Experimental | Drug: Venetoclax, Decitabine/Cedaruridine, Drug: decitabine/cedazuridineOlder AML patients have benefited from the advent of venetoclax + HMAs therapy, achieving higher remission rates and longer survival than previously possible. The next challenge is to sustain those remissions with a more acceptable toxicity profile and better quality of life. Building on landmark trials (VIALE-A) and emerging research on lower-dose strategies, we propose a phase 2 study of metronomic weekly Decitabine/cedazuridine plus venetoclax as maintenance therapy following initial composite CR response. This approach is grounded in strong biological rationale and preliminary clinical evidence suggesting feasibility and potential activity with improved tolerability. By transitioning patients to a maintenance phase of weekly low-dose therapy after maximum of 3 induction cycles of standard IV decitabine + venetoclax (to achieve CRi or better), we aim to evaluate whether remission can be maintained while minimizing toxicity and maximizing QOL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Newly diagnosed AML (WHO 2022 classification or ICC 2022 classification)
- Participants must be considered Ineligible for intensive induction defined by the following:
- Must have achieved CR,CRh, CRi, following induction with maximum 3 cycles of standard IV HMAs and venetoclax.
- Able to provide informed consent
- Prior and concomitant hydroxyurea is permitted
Key exclusion criteria (7 listed)
- Progression or relapse after induction standard HMAs + Venetoclax therapy
- Pregnancy or breastfeeding
- Uncontrolled infection, active CNS disease, or concurrent malignancy requiring systemic therapy
- Inability to take oral medication or presence of malabsorption syndrome or any other uncontrolled gastrointestinal condition
- Candidate for intensive chemotherapy
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 |
|---|---|---|
| Venetoclax, Decitabine/CedaruridinePatients who consent to the study will receive weekly Decitabine/Cedaruridine plus Venetoclax until intolerance or disease progression. Both Decitabine/Cedaruridine and Venetoclax are administered orally once on D1, 8, 15, 22 each | Drug | Venetoclax Plus HMA: A New Standard of Care for AML |
| decitabine/cedazuridinePatients who consent to the study will receive weekly decitabine/cedazuridine plus Venetoclax until intolerance or disease progression. Venetoclax is administered orally once on D1, 8, 15, 22 each 28-day cycle with food and water. Decitabine/Cedazuridine is administered orally once on D1, D8, D15 D22 with empty stomach. | Drug | Venetoclax Plus HMA: A New Standard of Care for AML |
Primary outcome
Primary Outcome
Time frame: 12 months
To evaluate the relapse free survival in patients with AML receiving metronomic maintenance therapy with weekly Decitabine/cedazuridine plus Venetoclax. RFS is measured from the date of first documented CR/CRi until the date of confirmed relapse or death from any cause, whichever occurs first.
2 secondary outcomes
Secondary Outcome 1
Time frame: 8 days
Secondary Outcome 2
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 9 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Xiaoyi Chen, MD, PhD principal investigator
Rutgers Cancer Institute of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Venetoclax, Decitabine/Cedaruridine and decitabine/cedazuridine in people with Acute Myeloid Leukaemia (AML), run by Rutgers, The State University of New Jersey 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 9 inclusion and 7 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: opening soon, as of the sponsor's last update on 9 Oct 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Xiaoyi Chen, MD, PhD (732-235-2465, xc458@cinj.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: 12 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 9 Oct 2026.