A Phase 2 Study of Revumenib With Chemotherapy for Children with Recurrent or Persistent Infant Leukemia

Full Title

A Phase 2 Study of SNDX-5613 in Combination with Chemotherapy for Patients with Relapsed or Refractory KMT2A-Rearranged Infant Leukemia (AALL2121) (CIRB)

Purpose

Researchers want to see how well revumenib works when given with chemotherapy to treat infant leukemia. The children in this study have acute leukemia that came back or keeps growing even after treatment. The leukemia has a gene rearrangement (genetic change) called KMT2A-R.

Revumenib targets the changes that occur in leukemia cells with a KMT2A rearrangement. It has been shown in laboratory studies to kill these cells.

If your child joins this study, they will sometimes take revumenib with chemotherapy and will sometimes take revumenib alone. Revumenib is taken orally (by mouth).

Who Can Join

To join this study, there are a few conditions. Your child must:

• Have acute lymphoblastic leukemia, acute leukemia of ambiguous lineage, or mixed phenotype acute leukemia. The leukemia must have kept growing or came back after treatment.
• Have infant leukemia with a KMT2A gene rearrangement.
• Have recovered from the serious side effects of prior leukemia treatments before getting the study therapy.
• Be age 1 month to less than 6 years old when joining the study. They must have been diagnosed with leukemia when they were under age 2 years.

Contact

For more information and to see if your child can join this study, please call 1-833-MSK-KIDS.