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RAVAML: Revumenib, Azacitidine, and Venetoclax for Pediatric AML

About this study

Patients with acute myeloid leukemia (AML) or acute leukemia of ambiguous lineage (ALAL) have white blood cells that are not normal. White blood cells are part of the body’s immune system and develop in the bone marrow. The abnormal cells grow faster in the bone marrow than other healthy cells and crowd them out. This makes it harder for patients with these diseases to fight infections.

These leukemias may be hard to treat. For some patients, treatment does not completely cure their leukemia. Their leukemia may not go away after treatment (refractory) or may come back after treatment (relapsed).

This study will test if a new drug called revumenib is a safe and effective treatment for these patients. Revumenib will be given along with 2 other drugs called azacitidine and venetoclax. Revumenib is not approved by the U.S. Food and Drug Administration (FDA). Azacitidine and venetoclax are both FDA-approved for treating certain types of leukemia in adults. While azacitidine and venetoclax are often used to treat AML in children, neither drug is approved by the FDA for this purpose.

We want to see if revumenib, azacitidine, and venetoclax (RAV) can help treat patients with these diseases. Giving these 3 drugs at the same time is experimental, as this is the first study using these drugs in pediatric patients.

Patients with relapsed leukemia have a higher risk of getting fungal infections. In this study, patients will take medicine to prevent or treat fungal infections. Some of these drugs could affect how revumenib works in the body and cause side effects. We want to find the best treatment for patients who take anti-fungal drugs and RAV.

Purpose of this clinical trial

  • Find out the dose of revumenib, azacitidine and venetoclax that can be used to safely treat children, adolescents, and young adults with refractory or relapsed AML or ALAL
  • Learn the side effects caused by this treatment
  • Find out if this treatment is effective
  • Learn how this treatment affects the body

Eligibility overview

  • 1–30 years old
  • Acute myeloid leukemia or acute leukemia of ambiguous lineage
  • Specific genetic changes
  • Adequate organ function

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Overview

Full title:

A Phase 1 Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients with Refractory or Relapsed Acute Myeloid Leukemia

Study goal:

Find out the dose of revumenib, azacitidine and venetoclax that can be used to safely treat children, adolescents, and young adults with refractory or relapsed AML or ALAL

Diagnosis:

Acute myeloid leukemia or acute leukemia of ambiguous lineage

Age:

1–30 years old

Clinical trials categories:

Childhood Cancer Leukemia Acute Myeloid Leukemia (AML)

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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