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
M.D. Anderson Cancer Center
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugDasatinib
Given orally daily for 3 cycles
- DrugRopeginterferon alfa-2b (P1101)
Given subcutaneous through injection
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas