Recruiting

Testing a New Drug to Prevent Leukemia Relapse After Stem Cell Transplant

Plain-English translation of NCT07101497 on ClinicalTrials.gov ↗ · Source last updated August 2025 · Translation generated July 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This study is testing a new medication called BN104 to see if it can help prevent acute leukemia from returning after you've had a stem cell transplant. BN104 is a drug that targets specific genetic changes found in leukemia cells. This medication has shown promise in treating leukemia that has come back or stopped responding to other treatments, but it hasn't yet been tested as a preventive ('maintenance') therapy after transplant.

After a stem cell transplant, patients with certain types of acute leukemia—especially those with specific genetic mutations—have a high risk of the disease coming back. This trial exists to find out whether this medication can reduce that risk and help keep people in remission longer.

Do you qualify?

You likely qualify if…

you are at least 12 years old and weigh at least 77 pounds
you have been diagnosed with acute myeloid leukemia, acute lymphoblastic leukemia, or another type of acute leukemia with specific genetic changes (NPM1 mutation, KMT2A rearrangement, or NUP98 rearrangement)
you have already received an allogeneic stem cell transplant (from a donor) within the past 30 to 180 days
you are in complete remission (no leukemia cells visible in your bone marrow) and your blood counts have recovered well after the transplant
your donor cells have fully replaced your own bone marrow cells (full donor chimerism) and you are not experiencing severe graft-versus-host disease

You likely don't qualify if…

you have an active, uncontrolled infection or signs of viral reactivation (such as CMV or EBV)
you have moderate or severe graft-versus-host disease requiring ongoing systemic treatment
you have significant heart disease, including inherited long QT syndrome or congestive heart failure
you are pregnant, breastfeeding, or have a known allergy to BN104
you have a gastrointestinal condition that prevents you from swallowing or absorbing oral medications

What participation looks like

You would take the medication by mouth twice a day for 24 to 36 months (about 2 to 3 years), with each month divided into cycles of 28 days. Your dose would be adjusted based on other medications you're taking and how you tolerate the treatment. Throughout the study, you'll have regular blood tests and bone marrow checks to monitor how well the medication is working and to watch for any side effects or signs that the leukemia is returning.

AI-generated summary from trial data · Jul 18, 2026 · Not medical advice

Trial locations(1 site)

China

The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu