drugset / Trial / NCT07053020

A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukemia (AML)

NCT07053020

Phase 1/2 Not yet recruiting 58 enrolled M.D. Anderson Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

The goal of Part 1 of this clinical research study is to find the highest tolerable dose of cladribine that can be given in combination with low dose cytarabine (LDAC) and venetoclax to patients who have AML. The goal of Part 2 of this clinical research study is to learn if the dose of cladribine found in Part 1, when combined with LDAC and venetoclax, can help to control the disease.

Timeline

Start
2027-12-01
Primary completion
2028-06-30
Completion
2030-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Cladribine Small molecule Oral
Background Cytarabine Small molecule Intravenous