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

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

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This study is now recruiting. Learn more about enrolling here.

Description
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. 

Eligibility and criteria
IRB Number:
22-020501
Eligible age range:
1 months - 21 years
Clinical trial phase:
Phase III
Official title:
A Randomized Phase 3 Trial of Fludarabine/Cytarabine/Gemtuzumab Ozogamicin With or Without Venetoclax in Children With Relapsed AML

What to expect
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).
Smiling CHOP patient holding shopping bag

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