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

Part of paid clinical trials in Burlington, Vermont.

Sponsor
University of Vermont
Study ID
NCT07014462
Phase
PHASE1
Status
Enrolling By Invitation

Conditions

  • AML - Acute Myeloid Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone plus Venetoclax-based Low-Intensity Therapy — DRUG
    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.

Study Details

This study is investigating whether adding dexamethasone, an anti-inflammatory medication, to a standard venetoclax-based low-intensity therapy (LIT) is safe and well-tolerated in patients with newly diagnosed Acute Myeloid Leukemia (AML) who are not eligible for intensive chemotherapy. Study Goals Primary Goal: To assess the safety and tolerability of dexamethasone in combination with venetoclax-based LIT. Secondary Goal: To evaluate how this treatment affects patients' quality of life using surveys. Exploratory Goal: To measure the treatment response, including remission rates and signs of minimal residual disease. What Happens in the Study? Patients will receive treatment over six cycles. Dexamethasone is given in different doses during the first six cycles along with venetoclax and another standard chemotherapy drug.

Key Dates

Start date
Sep 1, 2025
Status verified
Sep 2025
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adults with ND-AML
    This is a single-arm, phase 1b, investigator-initiated study evaluating the safety and tolerability of adding dexamethasone to standard venetoclax-based low-intensity therapy (LIT) regimens in treatment-naïve adult patients with acute myeloid leukemia (AML) who are unfit for intensive chemotherapy induction. Participants will receive venetoclax in combination with a hypomethylating agent (azacitidine or decitabine) or low-dose cytarabine, per treating physician's choice. Dexamethasone will be administered orally at 10 mg twice daily on days 1-3 of cycles 1 and 2, and 20 mg once on day 1 of cycles 3 through 6. Treatment will continue for up to 6 cycles (28 days each). The study also includes assessments of patient-reported outcomes and exploratory efficacy endpoints.

Primary Outcome Measure

Safety and tolerability of adding dexamethasone to venetoclax-based low-intensity therapy in treatment-naïve AML patients [ Time Frame: From start of treatment through completion of 6 cycles (each cycle is 28 days; approximately 6 months total) ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Vermont Medical CenterBurlingtonVermont05401-

Find similar trials in Burlington, VT

By research site
University of Vermont Medical Center· Burlington, VT

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