NCT06817720

Phase II Study Assessing the Efficacy and Toxicity of Olverembatinib Monotherapy 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 olverembatinib can help to control newly diagnosed CML in the chronic phase.

Detailed description

Primary Objectives * To assess the rate of MMR by 12 months. Secondary Objectives * To assess the rate of CCyR 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 sustained deep molecular response. * To estimate event-free survival and overall survival. * To assess the toxicity of olverembatinib monotherapy. * To assess health-related quality of life (HRQOL) of the participants.

Conditions

• Chronic Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	olverembatinib	GIven by PO

Timeline

• Start date: 2025-10-13
• Primary completion: 2027-03-07
• Completion: 2027-03-07
• First posted: 2025-02-10
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study