Fludarabine/Cytarabine/Gemtuzumab Ozogamicin With or Without Venetoclax in Relapsed AML

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This study involves taking a study drug called venetoclax with or without standard of care chemotherapy. The overall goal of this study is to see if adding venetoclax to standard chemotherapy leads to improved survival for children and young adults with relapsed acute myeloid leukemia (AML). The study may last up to 9 years and will enroll male and female patients from the ages of 29 days to 21 years of age. 

Who Do I Contact?

If you are interested in participating in the study or want to learn more please contact our study team at robinsonj9 [at] chop.edu or 215-590-2053.

Eligibility & Criteria

IRB #:
22-020501
Official Title:
A Randomized Phase 3 Trial of Fludarabine/Cytarabine/Gemtuzumab Ozogamicin With or Without Venetoclax in Children With Relapsed AML
Study Phase:
Phase III
Eligible Age Range:
1 Months - 21 Years
Gender:
All
Study Categories:

Visit Criteria

Participants will receive venetoclax via tablet or as a powder mixed with food or a drink. Study visits will include the following assessments: blood draws, questionnaires, pregnancy testing/birth control, genetic testing, and tissue collections (archived and fresh from bone marrow biopsies performed as standard of care).

Leader
Sarah K. Tasian

Sarah Tasian, MD