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AALL2121: SNDX-5613 and Chemotherapy for Infant Leukemia

About this study

Certain children who complete leukemia treatment have a high risk that their cancer will come back (relapse) or not respond to treatment (refractory). This study is for children who have a change (mutation) in their genes known as KMT2A-rearranged or KMT2A-R. Children with this genetic change have a higher risk of their leukemia returning after treatment.

This clinical trial is for children with KMT2A-R leukemia who have relapsed or have refractory disease. The study tests a medicine called SNDX-5613 (revumenib) that is given with chemotherapy. The trial will see if the treatment is safe and helpful for these children. We will also find the best dose of medicine to use.

Patients will supply blood and bone marrow samples for testing. This trial will last up to about 16 months, with follow-up for about 5 years.

Eligibility overview

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Overview

Full title:

AALL2121, A Phase 2 study of SNDX-5613 in combination with chemotherapy for patients with relapsed or refractory KMT2A-R infant leukemia

Study goal:

To find the best dose of SNDX-5613 to use along with chemotherapy for young patients with KMT2A-R leukemia

Diagnosis:

Acute lymphoblastic leukemia (ALL); acute leukemia of ambiguous lineage (ALAL); mixed phenotype acute leukemia (MPAL); or acute myeloid leukemia (AML) that was previously ALL, ALAL, or MPAL with a KMT2A gene rearrangement 

Age:

1 month to 5 years old

Clinical trials categories:

Mixed Phenotype Acute Leukemia Acute Myeloid Leukemia (AML) Leukemia

Acute Leukemia of Ambiguous Lineage (ALAL)

Acute Lymphoblastic Leukemia (ALL)

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.

 

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