Full Title
Randomized phase 3 trial of fludarabine/cytarabine/gemtuzumab ozogamicin with or without venetoclax in children with relapsed AML [ITCC-101/APAL2020D]Purpose
Researchers in this study want to determine if combining the drug venetoclax with standard chemotherapy may be more effective than standard chemotherapy alone in children and adolescents with relapsed acute myeloid leukemia (AML). Venetoclax blocks Bcl-2, a protein that helps cancer cells to survive and resist the effects of cancer treatments. By blocking Bcl-2, venetoclax may kill cancer cells and/or make other treatments more effective.
Participants in this study will be randomly assigned to receive standard chemotherapy (fludarabine, cytarabine, and gemtuzumab ozogamicin) alone or in combination with venetoclax. The chemotherapy drugs are given intravenously (by vein) and venetoclax is taken orally (by mouth).
Contact
For more information about this study and to inquire about eligibility, please contact 1-833-MSK-KIDS.