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
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.
- 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