Clinical Trial

Trial of Revumenib Plus FLA Chemotherapy for Children With Relapsed or Refractory NUP98-rearranged AML."

Not Yet Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to learn if Revumenib in combination with Fludarabine and Cytarabine can treat children with NUP98-rearranged relapsed or refractory Acute Myeloid Leukemia. The main question it aims to answer is: What is the Best Overall Response Rate by morphologic response criteria after up to two cycles of revumenib in combination with fludarabine and cytarabine (FLA) chemotherapy? Participants will receive up to two cycles of Revumenib in combination with fludarabine and cytarabine with intrathecal triple therapy. Participant may also receive a stem cell transplant followed by Revumenib monotherapy if it is necessary. Up to 27 children and young adults will be enrolled.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-07-02.
Trial Details
NCT Number NCT07686107
Lead Sponsor Therapeutic Advances in Childhood Leukemia Consortium
Conditions Leukemia, Myeloid, Acute
Enrollment 24 participants
Start Date 2026-08-31
Primary Completion 2029-12-31 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-22