drugset
drugset / Trial / NCT07686107

Phase 2 Trial of Revumenib Plus FLA Chemotherapy for Children With Relapsed or Refractory NUP98-rearranged AML."

NCT07686107 ↗

Phase 2 Not yet recruiting 24 enrolled Therapeutic Advances in Childhood Leukemia Consortium
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2026-08-31
Primary completion
2029-12-31
Completion
2030-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Revumenib Small molecule 95 mg/m2 Oral
Subject Revumenib Small molecule 160 mg Oral
Background Cytarabine Small molecule 18 mg Intrathecal
Background Cytarabine Small molecule 24 mg Intrathecal
Background Cytarabine Small molecule 30 mg Intrathecal
Background Cytarabine Small molecule 36 mg Intrathecal
Background Cytarabine Small molecule 300 mg Intrathecal
Background Cytarabine Small molecule 420 mg Intrathecal
Background Cytarabine Small molecule 560 mg Intrathecal
Background Cytarabine Small molecule 680 mg Intrathecal
Background Cytarabine Small molecule 820 mg Intrathecal
Background Cytarabine Small molecule 960 mg Intrathecal
Background Cytarabine Small molecule 1100 mg Intrathecal
Background Cytarabine Small molecule 2000 mg/m2 Intrathecal
Background Fludarabine Small molecule 5 mg —
Background Fludarabine Small molecule 6.25 mg —
Background Fludarabine Small molecule 8.75 mg —
Background Fludarabine Small molecule 10 mg —
Background Fludarabine Small molecule 12.5 mg —
Background Fludarabine Small molecule 15 mg —
Background Fludarabine Small molecule 16.25 mg —
Background Fludarabine Small molecule 30 mg/m2 —
Background Hydrocortisone Other / unclassified 12 mg Intrathecal
Background Hydrocortisone Other / unclassified 16 mg Intrathecal
Background Hydrocortisone Other / unclassified 20 mg Intrathecal
Background Hydrocortisone Other / unclassified 24 mg Intrathecal
Background Methotrexate Small molecule 6 mg Intrathecal
Background Methotrexate Small molecule 8 mg Intrathecal
Background Methotrexate Small molecule 10 mg Intrathecal
Background Methotrexate Small molecule 12 mg Intrathecal

Indications

acute myeloid leukemia