NCT06236724

Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if asciminib can help to control CML. The safety and effects of this drug will also be studied.

Detailed description

Primary Objectives: • To assess the rate of major molecular response (MMR) by 12-months. Secondary Objectives: * To assess the rate of complete cytogenetic response (CCyR, or PCR ≤ 1% IS) by 12 months * To estimate the proportion of participants with 4.5-log reduction of BCR::ABL1 transcripts (MR4.5) at 6-, 12-,18-, 24-, and 36 months of therapy. * To estimate the rate of TFR * To estimate the time to progression, progression-free survival, and overall survival. * To assess the toxicity of this dosing schedule by evaluating the adverse events that occur while the participant is on asciminib therapy * To estimate the proportion of participants with sustained MR4.5 of 3 years and more. * To estimate the cumulative overall rate of MR4.5.

Conditions

• Chronic Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Asciminib	Given by PO

Timeline

• Start date: 2024-01-31
• Primary completion: 2033-07-01
• Completion: 2035-07-01
• First posted: 2024-02-01
• Last updated: 2026-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study