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.

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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

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~40 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:DasatinibRopeginterferon alfa-2b (P1101)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year
Chronic Myeloid Leukemia
1 sites across 1 states
Texas1
  • Fadi Haddad, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Postmenopausal (no menses in greater than or equal to 12 consecutive months).
History of hysterectomy or bilateral salpingo-oophorectomy.
Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
History of bilateral tubal ligation or another surgical sterilization procedure.
  • 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