NCT07053020

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objective: The primary objective of Phase 1 is to determine safety and tolerability of oral cladribine in patients with AML and to identify a RP2D. Secondary Objective: The secondary objectives of Phase 1 are to provide a qualitative assessment of systemic exposure based on plasma cladribine concentrations after administration of oral cladribine to patients with AML and to explore the activity of cladribine/LDAC/venetoclax in patients with relapsed or refractory AML.

Conditions

• Acute Myeloid Leukemia (AML)

Interventions

Type	Name	Description
DRUG	Cytarabine	Given by intravenous adminstration
DRUG	Oral Cladribine	Given Orally

Timeline

• Start date: 2027-12-01
• Primary completion: 2028-06-30
• Completion: 2030-06-30
• First posted: 2025-07-08
• Last updated: 2026-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study