Recruiting

Testing if adding a third drug improves treatment for a rare blood cancer

Plain-English translation of NCT07075016 on ClinicalTrials.gov ↗ · Source last updated August 2025 · Translation generated June 2026 · How we translate trials

Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This trial is testing whether adding venetoclax to a standard two-drug combination (ivosidenib and azacitidine) can help treat a specific type of blood cancer called AML that has an IDH1 gene mutation. You would receive either the two standard medications plus venetoclax, or the two standard medications plus a placebo (a fake pill with no active drug). The goal is to see if the medication helps patients live longer and feel better.

Currently, the two-drug combination is the standard treatment for this type of AML in patients who cannot handle intensive chemotherapy. Doctors want to know if adding this medication could work even better, giving patients a chance at improved survival and outcomes.

Do you qualify?

You likely qualify if…

you have been newly diagnosed with a specific type of blood cancer (AML or MDS/AML) that has an IDH1 gene mutation
you are at least 18 years old with no upper age limit
you are not eligible for intensive chemotherapy (either because you are 75 or older, or because you have health conditions like heart problems, lung problems, or kidney problems that make intensive treatment unsafe)
you have an expected life expectancy of at least 12 weeks
your kidney and liver function test results are at acceptable levels

You likely don't qualify if…

you have a very high white blood cell count that cannot be safely managed
you are pregnant or plan to become pregnant during the trial
you have severe liver or kidney damage beyond what the study allows
you cannot commit to the full length of the study or follow the treatment schedule

What participation looks like

You will take two or three medications (depending on which group you are assigned to) in 28-day cycles, continuing as long as the treatment is working and you are not experiencing serious side effects. You will have regular visits with your doctor for blood tests, physical exams, and check-ins to monitor how you are responding to treatment and any side effects. The treatment continues until the cancer stops responding, gets worse, you develop unacceptable side effects, or you decide to withdraw from the study.

AI-generated summary from trial data · Jun 6, 2026 · Not medical advice

Testing if adding a third drug improves treatment for a rare blood cancer

What is this trial?

Do you qualify?

What participation looks like

Trial locations(119 sites)