Testing a new drug combination for children with hard-to-treat blood cancers

Plain-English translation of NCT06466395 on ClinicalTrials.gov ↗ · Source last updated June 2026 · Translation generated June 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

This trial is testing whether adding to a standard chemotherapy regimen called can help children and young adults whose leukemia has come back or stopped responding to treatment. The study will first figure out the safest dose of to use with this chemotherapy combination, then test whether it actually helps patients go into remission. Researchers want to understand how well this medication works and what side effects patients experience.

Leukemia that returns after treatment or resists initial therapy is very serious and hard to treat — standard options don't always work well enough. This medication has shown promise in adult patients with similar blood cancers, and researchers believe combining it with chemotherapy might give children and young adults a better chance at remission and survival.

Do you qualify?

You likely qualify if…

you are between 2 and 21 years old
you have been diagnosed with relapsed or refractory acute lymphoid leukemia (including bi-phenotypic or undifferentiated types) with at least 5% cancer cells in your bone marrow or blood
you are in good enough overall health to tolerate intensive chemotherapy, as measured by your doctors
you have been off other cancer treatments for at least 2 weeks (or longer depending on the drug), unless you're taking hydroxyurea, steroids, or low-dose chemotherapy to control your cancer
your heart, liver, and kidneys are working well enough based on recent blood and organ function tests

You likely don't qualify if…

you are pregnant or nursing, or unwilling to use effective birth control if you could become pregnant
you have severe liver disease or your bilirubin levels are too high
your kidneys are not working well enough (creatinine clearance below 30 mL/min) unless it's directly caused by your leukemia
you are taking certain other medications that interfere with venetoclax, or you're on high-dose steroids (more than the study allows)
you have a life expectancy too short to benefit from the treatment, as determined by your doctor

What participation looks like

In the first part of the study, your doctors will give you the chemotherapy combination () along with increasing doses of to find the safest dose. In the second part, new patients will receive the best dose that was found. You'll receive treatment in cycles (chemotherapy given over several days, followed by a rest period), and you'll have regular blood tests, bone marrow checks, and scans to see how you're responding. The study team will closely watch for side effects and adjust your care as needed.

AI-generated summary from trial data · Jun 29, 2026 · Not medical advice

Trial locations(1 site)

United States

MD Anderson Cancer Center, Houston, Texas