M.D. Anderson Cancer Center
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.
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…
Inclusion Criteria: Adult patients age ≥18 years. Patients must have a diagnosis of Ph-positive or BCR::ABL1 positive CML in chronic phase. Patients who received prior hydroxyurea, 1 to 2 doses of cytarabine, and/or an FDA approved TKI for \<30 days are eligible. Patients with additional chromosomal abnormalities at diagnosis (early disease) and no other criteria for accelerated phase will be eligible for this study. ECOG performance status ≤2. Patients must have adequate end organ function, defined as the following: total bilirubin ≤1.5x ULN (unless secondary to Gilbert's disease, in w…
Given orally daily for 3 cycles
Given subcutaneous through injection
Arctuva estimate
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