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SELCLAX: A Study of Venetoclax and Selinexor with Chemotherapy in Children with AML

About this study

This is a study of two new drugs called venetoclax and selinexor. Doctors want to find out if these drugs are safe and if they have beneficial effects in children, adolescents and young adults when combined with standard chemotherapy for AML. Chemotherapy is anti-cancer medicine.

The U.S. Food and Drug Administration (FDA) has approved venetoclax to treat AML and some other types of leukemia in adults. The FDA has also approved selinexor to treat certain types of lymphoma and multiple myeloma in adults. However, the FDA has not approved venetoclax or selinexor to treat AML in children.

There are two parts to this study. Part 1 will decide the highest dose of venetoclax, selinexor and chemotherapy that is safe to give patients. Part 2 will look at the effects of this treatment.

Eligibility overview

  • Diagnosis of one of the following:
    • Relapsed or refractory acute myeloid leukemia (AML)
    • Acute leukemia of ambiguous lineage (ALAL)
  • 2 years to 30 years of age (2 years to 24 years at St. Jude)
  • Ineligible for other curative therapy

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Overview

Full title:

A Phase I and Expansion Cohort Study of Selinexor and Venetoclax in Combination With Chemotherapy in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia

Study goal:

The main goals of this study are to test the safety of venetoclax and selinexor and find the highest dose that is safe to give when combined with chemotherapy drugs. Researchers also want to find out about any side effects and learn how the treatment affects your body.

Diagnosis:

Acute myeloid leukemia

Age:

30 years or younger

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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