NCT07014462

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

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Vermont · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• AML - Acute Myeloid Leukemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2029-06-01
• Completion: 2029-06-01
• First posted: 2025-06-11
• Last updated: 2025-10-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study