New pill shows promise for Tough-to-Treat leukemias

NCT ID NCT02392572

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests an oral drug called ONC201 in people whose acute leukemia or high-risk myelodysplastic syndrome (MDS) has returned or not responded to standard treatments. The trial has two phases: Phase I finds the safest dose, and Phase II checks if the drug shrinks or controls the cancer. About 120 adults will take part, and some may also receive a second drug called venetoclax.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

ONC201 (a drug that may block enzymes needed for cancer cell growth, sometimes given with venetoclax)

What this could lead to

If it works, this could offer a new treatment option for people with leukemia or MDS that has come back or stopped responding to other therapies.

What could go wrong

This is an early-phase trial (Phase I/II) with only 120 participants, so the drug may not prove effective or may have side effects. It is not yet known if it works better than existing treatments.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for RECURRENT ACUTE MYELOID LEUKEMIA are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia acute myeloid leukemia myelodysplastic syndrome Myelodysplastic Syndromes Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • M D Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

    Contact Phone: •••-•••-••••

    Contact