Atovaquone (Mepron®) Combined with Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML)

EARLY_PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

July 10, 2018

Primary Completion Date

September 29, 2020

Study Completion Date

October 31, 2025

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

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."

DRUG

Cytarabine

As part of routine Induction 1 chemotherapy (ADE 10+3+5)

DRUG

Daunorubicin

As part of routine Induction 1 chemotherapy (ADE 10+3+5)

DRUG

Etoposide

As part of routine Induction 1 chemotherapy (ADE 10+3+5)

DRUG

Gemtuzumab Ozogamicin

As part of routine Induction 1 chemotherapy(DA 3+10 + GO)

Trial Locations (2)

21205

Johns Hopkins Medicine, Baltimore

77030

Baylor College of Medicine - Texas Childrens Hospital, Houston

All Listed Sponsors
collaborator

William Marsh Rice University

OTHER

lead

Baylor College of Medicine

OTHER