NCT06629584

Phase II Study of Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, phase 2 study investigating asciminib in patients previously treated with one line of TKI therapy.

Detailed description

Primary Objectives: 1\. To determine the rate of major molecular response (MMR) at 12 months. Secondary Objectives: 1. To estimate the proportion of patients achieving a complete cytogenetic response (CCyR), major molecular response (MMR) and molecular response 4 and MR4.5 (MR4.5) by 3, 6, 12 (except for MMR as primary endpoint), 18 and 24 months. 2. To estimate the time to CCyR, MMR, MR4.0 and MR4.5. 3. To determine the safety and tolerability profile of asciminib in the second line setting. 4. To determine the event-free survival (EFS), survival free from transformation to accelerated and blast phase (TFS), and overall survival (OS). 5. To evaluate the rate of adverse events (AEs) Exploratory Objectives: 1. To describe patient reported outcomes using the MDASI-CML instrument 2. To evaluate development of resistance mutations and their impact on outcomes

Conditions

• Malignant Solid Tumors

Interventions

Type	Name	Description
DRUG	Asciminib	Patients will receive asciminib 80 mg PO once daily continuously for 28-day cycles for 2 years.

Timeline

• Start date: 2025-02-14
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2024-10-08
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study