NCT07269470

Phase II Study Assessing the Safety and Efficacy of Dasatinib in Combination With Ropeginterferon in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

• Status: Not Yet 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

The goal of this clinical research study is to find out if treatment with a combination of dasatinib plus ropeginterferon can help to control CML-CP. The safety of this combination will also be studied.

Detailed description

Primary Objective: To assess the rate of molecular response 4.5 (4.5 log-reduction of BCR::ABL1 transcripts or level ≤ 0.0032% IS) by 12 months of therapy Secondary Objectives: To assess the rate of complete cytogenetic response (BCR::ABL1 transcripts ≤ 1% IS) by 12 months of therapy To assess the rate of major molecular response (BCR::ABL1 transcripts ≤ 0.1% IS) by 12 months of therapy To estimate the proportion of patients achieving MR4.5 at 6, 18, 24, and 36 months of therapy To estimate the rate of sustained deep molecular response (DMR; BCR::ABL1 transcripts ≤ 0.01% IS) for 2 years and longer To evaluate the safety of the combination To assess event-free survival and overall survival for 10 years after the last patient is enrolled

Conditions

• Chronic Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Dasatinib	Given orally daily for 3 cycles
DRUG	Ropeginterferon alfa-2b (P1101)	Given subcutaneous through injection

Timeline

• Start date: 2026-05-01
• Primary completion: 2029-11-01
• Completion: 2029-11-01
• First posted: 2025-12-08
• Last updated: 2025-12-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study