A Phase 1B Investigator Initiated Study of Safety and Tolerability of Dexamethasone (D) in Combination With Venetoclax-based Low-Intensity Therapy (LIT) in Treatment-Naïve Acute Myeloid Leukemia (AML): DLIT-AML

PHASE1Enrolling by invitationINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

June 30, 2029

Study Completion Date

June 30, 2029

Conditions
AML - Acute Myeloid Leukemia
Interventions
DRUG

Dexamethasone plus Venetoclax-based Low-Intensity Therapy

Participants will receive standard low-intensity therapy (LIT) regimens for newly diagnosed AML, which may include venetoclax combined with either azacitidine, decitabine, or low-dose cytarabine, per treating physician's discretion. In addition, participants will receive dexamethasone administered orally at 10 mg twice daily on days 1-3 of cycles 1 and 2, and 20 mg orally on day 1 of cycles 3 through 6. This intervention is being studied to evaluate whether the addition of dexamethasone improves tolerability and clinical outcomes in patients unfit for intensive chemotherapy.

Trial Locations (1)

05401

University of Vermont Medical Center, Burlington

All Listed Sponsors
lead

University of Vermont

OTHER