Phase II De-Escalation Study of Metronomic Decitabine/Cedazuridine Plus Venetoclax in AML

NCT07867626 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 022604Pro2026001077
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Acute Myeloid Leukaemia (AML)

Keywords

acute myeloid leukemia; Venetocalx; Decitabine/Cedazuridine

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (2)

• Secondary Outcome 1

  8 days

• Secondary Outcome 2

  24 months

Study Arms (1)

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.

Drug: Venetoclax, Decitabine/Cedaruridine; Drug: decitabine/cedazuridine

Interventions

Venetoclax, Decitabine/Cedaruridine DRUG

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

Venetoclax Plus HMA: A New Standard of Care for AML

decitabine/cedazuridine DRUG

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.

Venetoclax Plus HMA: A New Standard of Care for AML

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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).
• 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
• ECOG performance status 0 to 3

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers Cancer Institute

New Brunswick, New Jersey, 08902, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax; Decitabine; decitabine and cedazuridine drug combination

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Xiaoyi Chen, MD, PhD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoyi Chen, MD, PhD

CONTACT

732-235-2465; xc458@cinj.rutgers.edu

Elayne Wesolowsky

CONTACT

732-425-3023; wesoloel@cinj.rutgers.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hematologist Oncologist, Rutgers Cancer Institute

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 9, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: October 9, 2026

Record last verified: 2026-10

Locations

US (1)