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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

Enrolling by Invitation
PHASE1Ages 18+InterventionalTreatment
University of Vermont
~20 participants
Updated 2025-10-06 on ClinicalTrials.gov
What's tested:Dexamethasone plus Venetoclax-based Low-Intensity Therapy

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and tolerability of adding dexamethasone to venetoclax-based low-intensity therapy in treatment-naïve AML patients
Measured over From start of treatment through completion of 6 cycles (each cycle is 28 days; approximately 6 months total)

Conditions

AML - Acute Myeloid Leukemia

Explore related trials

Acute Myeloid Leukemia

Where it's being run

1 sites across 1 states
Vermont1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Has not undergone a hysterectomy or bilateral oophorectomy; or
Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

What this trial measures

  • Safety and tolerability of adding dexamethasone to venetoclax-based low-intensity therapy in treatment-naïve AML patientsFrom start of treatment through completion of 6 cycles (each cycle is 28 days; approximately 6 months total)

    The primary outcome will assess the safety and tolerability of the combined regimen. This will include the incidence and severity of adverse events (AEs) graded by NCI CTCAE v5.0, with special attention to clinically significant non-hematologic grade 4 AEs during the first 2 cycles. Overall AE frequency, organ system affected, and hematologic vs. non-hematologic classification will be recorded. Short-term toxicity will be reviewed after enrollment of the first 8-10 patients to determine feasibility for continued accrual.