A Phase II De-Escalation Study of Metronomic Decitabine/Cedazuridine Plus Venetoclax in Acute Myeloid Leukemia Maintenance.
Primary Objective:
To evaluate treatment interruption in patients with AML who receive metronomic maintenance therapy with weekly O-dec plus Ven: defined as treatment delay for more than 72 hours or cancellation of treatment due to treatment causing adverse effects.
Secondary Objectives:
- To evaluate the treatment-limiting toxicity in patients with AML who receive metronomic maintenance therapy.
- 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.
- To assess event-free survival (EFS), defined as the time from initiation of maintenance therapy to the date of earliest evidence of relapse or death.
- To determine the duration of relapse-free survival (RFS) in AML patients who has complete remission (CR) or CR with incomplete hematological recovery (CRi).
- RWJBarnabas Health
- Community Medical Center
- Cooperman Barnabas, Livingston
- Monmouth Medical Center
- Rutgers University
Inclusion Criteria: - Newly diagnosed AML (WHO 2022 classification or ICC 2022 classification) - Participants must be considered Ineligible for intensive induction defined by the following: 1. Age 75 years or older, or 2. 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 Exclusion Criteria: - 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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.