Testing a new medication combined with standard chemotherapy for newly diagnosed blood cancer

Plain-English translation of NCT05445154 on ClinicalTrials.gov ↗ · Source last updated July 2022 · Translation generated June 2026 · How we translate trials

Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.

What is this trial?

This trial is testing a new medication called SKLB1028 combined with two standard chemotherapy drugs (daunorubicin and cytarabine) in people who have just been diagnosed with acute myeloid leukemia (AML) and have a specific genetic change called an FLT3 mutation. The study wants to find the right dose of the medication and understand how safe and tolerable this combination is for patients.

Acute myeloid leukemia is a serious blood cancer, and while standard chemotherapy helps some patients, researchers are looking for ways to improve outcomes. This medication may work better when combined with standard treatment, especially for patients whose leukemia has this particular genetic mutation.

Do you qualify?

You likely qualify if…

you are between 18 and 60 years old
you have been newly diagnosed with acute myeloid leukemia (not previously treated) with a specific genetic mutation called FLT3
your leukemia has more than 20% blast cells in your bone marrow
your overall health and ability to carry out daily activities are good enough for chemotherapy treatment (ECOG score of 2 or better)
your liver and kidney function test results are acceptable for the study

You likely don't qualify if…

you have a specific type of leukemia called acute promyelocytic leukemia or BCR-ABL positive leukemia
you have been diagnosed with another active cancer in addition to your leukemia
you have had major surgery on vital organs recently and have not fully recovered
you have serious blood clotting disorders or conditions like disseminated intravascular coagulation
you have received prior chemotherapy or radiation treatment for other cancers that led to your leukemia

What participation looks like

You would take capsules of the new medication by mouth, starting at 100 mg twice daily, while also receiving the two standard chemotherapy drugs through intravenous infusion on a set schedule. The study has two phases: in Phase 1, researchers gradually increase doses in small groups of patients to find the safest dose; in Phase 2, once the right dose is found, additional patients are enrolled to confirm safety and effectiveness. You would have regular blood tests and doctor visits to monitor how you're responding and check for any side effects.

AI-generated summary from trial data · Jun 3, 2026 · Not medical advice

Trial locations(1 site)

China

West China Hospital of Sichuan University, Chengdu