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APAL2020K: Ziftomenib and Chemotherapy for Acute Leukemia

About this study

Children with acute leukemias that return (relapse) or who do not respond to treatment (refractory) have a poor prognosis. New treatments are needed.

Ziftomenib is a medicine that has not yet been approved by the Food and Drug Administration (FDA). Previous studies in adults have shown that this drug may be a safe and effective treatment for those who have certain gene (DNA) changes, also known as mutations. These mutations are called KMT2A-r, NUP98-r, or NPM1-m.

This study will use ziftomenib along with fludarabine and cytarabine (FLA) chemotherapy to treat children, adolescents, and young adults with these mutations who have relapsed or refractory disease.

The goal is to cause leukemia to go into remission (no signs or symptoms of leukemia) and then move to a bone marrow (stem cell) transplant after 1 or 2 cycles of ziftomenib along with FLA chemotherapy. We hope to continue giving ziftomenib alone to patients who cannot have transplants.

Eligibility overview

  • Up to 21 years old
  • KMT2A-r, NUP98-r, or NPM1-m acute leukemia
  • Bone marrow relapse
  • Relapsed or refractory disease

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Overview

Full title:

APAL2020K: Phase I Trial of Menin-Inhibitor, Ziftomenib, in Combination with Chemotherapy for Children with Relapsed/Refractory KMT2A-rearranged, NUP98-rearranged, or NPM1-mutant Acute Leukemia

Study goal:

To test whether ziftomenib, along with standard chemotherapy, helps in the treatment of children, adolescents, and young adults with relapsed or refractory KMT2A-r, NUP98-r, or NPM1-m acute leukemia; to find the best dose of ziftomenib that can be given safely; and to find out what side effects this treatment can cause.

Diagnosis:

Acute Lymphoblastic Leukemia (ALL); Mixed-phenotype Acute Leukemia (MPAL); Acute Myeloid Leukemia (AML)

Age:

Up to 21 years old

Clinical trials categories:

Childhood Cancer

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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