A Phase 2 interventional study of Venetoclax, Decitabine/Cedaruridine and decitabine/cedazuridine in Acute Myeloid Leukaemia (AML), sponsored by Rutgers, The State University of New Jersey. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Rutgers, The State University of New Jersey · Phase 2, Interventional, and Treatment
To evaluate the 12-month relapse free survival with weekly Decitabine/cedazuridine plus Venetoclax in AML maintenance after achieving composite CR (CR, CRi, CRh)
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.
3,035 studies on the registry are indexed under Leukemia, Myeloid, Acute; 746 are open to participants now.
This study's planned enrollment of 41 is close to the median of 40 across 2,561 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →Rutgers, The State University of New Jersey is the lead sponsor of 504 studies on the registry; 131 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 31 (79%) have results posted.
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Participants must be considered Ineligible for intensive induction defined by the following:
i) 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).
Exclusion Criteria:
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.
Drug: Venetoclax, Decitabine/Cedaruridine · Drug: decitabine/cedazuridine
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
Drug pages: Decitabine · Cedazuridine
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.
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.
Time frame: 12 months
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.
Time frame: 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.
Time frame: 24 months
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Jun 2028, 21 months later.
Of 327 non-industry phase 2 interventional studies under Leukemia, Myeloid, Acute, half reached primary completion within 72 months of starting (the median), counting those still running; a quarter within 44 and three quarters within 108. This study's planned 21 months is below that.
Counting every sponsor, half of 381 studies reached it within 62 months; a quarter within 40 and three quarters within 104.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Decitabine · Cedazuridine
Rutgers, The State University of New Jersey →