Phase II Study of Dasatinib and Ropeginterferon for Newly Diagnosed CML
This study is looking at a new combination treatment for people with newly diagnosed Chronic Myeloid Leukemia (CML) in chronic phase. It combines two drugs: dasatinib, given daily by mouth, and ropeginterferon alfa-2b, given by injection under the skin. The main goal is to see how safe this combination is and how well it helps control CML. Researchers will measure how much the cancer cells (BCR::ABL1 transcripts) are reduced after 12 months of treatment. You might be able to join if you are an adult (18 or older) with CML in chronic phase, even if you've had a short course of other treatments like hydroxyurea or a TKI (tyrosine kinase inhibitor) for less than 30 days. The study plans to enroll 40 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 40 participants.
- What's involved
- You would take dasatinib orally every day and receive ropeginterferon alfa-2b by subcutaneous injection. The primary endpoint for safety is measured through study completion, an average of 1 year.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess event-free survival and overall survival for 10 years after the last patient is enrolled.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Fadi Haddad, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Safety and Adverse Events (AEs)Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0