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RAVEN: Clinical Trial to Treat Relapsed Acute Lymphoblastic Leukemia with Venetoclax and Navitoclax

About this study

This is a research study for patients who have acute lymphoblastic leukemia (ALL) that has come back after treatment (relapsed). Researchers want to find out if two new drugs called venetoclax and navitoclax are safe and if they are beneficial for children, adolescents and young adults when combined with chemotherapy.

Venetoclax is approved by the U.S. Food and Drug Administration (FDA) to treat certain types of leukemia in adults. Venetoclax is not approved by the FDA for treating childhood leukemia. Navitoclax is not approved by the FDA.

Purpose of this clinical trial

The main goal of this study is to find out the good and bad effects of treatment with venetoclax and navitoclax when given with chemotherapy to children with relapsed and refractory ALL.

Eligibility overview

Inclusion criteria include:

  • Diagnosed with acute lymphoblastic leukemia or lymphoma that has come back
  • Between 4 and 30 years old
  • Weigh more than 20 kg (44.09 lbs.)
  • Able to swallow pills
  • Has not taken navitoclax in the past
  • Fully recovered from effects of any earlier treatment

Exclusion criteria:

  • HIV infection or active hepatitis B or C infection
  • Pregnant or breastfeeding

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The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

Overview

Full title:

A Phase I/II Trial Treating Relapsed Acute Lymphoblastic Leukemia with Venetoclax and Navitoclax

Study goal:

The main goal of this study is to find out the good and bad effects of treatment with venetoclax and navitoclax when given with chemotherapy to children with relapsed and refractory ALL.

Diagnosis:

Acute lymphoblastic leukemia (ALL) and lymphoma

Age:

4 years to 30 years

Clinical trials categories:

Childhood Cancer Lymphoma Leukemia 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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