26
Participants
Start Date
July 10, 2018
Primary Completion Date
September 29, 2020
Study Completion Date
October 31, 2025
Atovaquone
"Patients will receive standard of care MRC based Induction chemotherapy (such as ADE 10+3+5 with daily atovaquone dosing starting on day 6. In order to accommodate potential drug shortages modifications to ADE 10+3+5 that retain the MRC based induction backbone regimen of DA are allowed (see second Arm). These include but are not limited to substitution of etopophos for etoposide, exclusion of etoposide, use of CPX-351 (VYXEOS (daunorubicin and cytarabine) liposome) only, and daunorubicin and cytarabine (DA) + gemtuzumab ozogamicin (GO).~Patients will be monitored for adherence to and tolerance of daily dosing of atovaquone. Peripheral blood (PB) and bone marrow plasma samples will be obtained to measure atovaquone concentrations."
Cytarabine
As part of routine Induction 1 chemotherapy (ADE 10+3+5)
Daunorubicin
As part of routine Induction 1 chemotherapy (ADE 10+3+5)
Etoposide
As part of routine Induction 1 chemotherapy (ADE 10+3+5)
Gemtuzumab Ozogamicin
As part of routine Induction 1 chemotherapy(DA 3+10 + GO)
Johns Hopkins Medicine, Baltimore
Baylor College of Medicine - Texas Childrens Hospital, Houston
William Marsh Rice University
OTHER
Baylor College of Medicine
OTHER