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Atovaquone (Mepron®) Combined With Conventional Chemotherapy for de Novo Acute Myeloid Leukemia (AML)

NCT03568994 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2026-01-27

No results posted yet for this study

Summary

This study will test daily dosing of atovaquone at established pneumocystis jiroveci pneumonia (PJP) prophylaxis dosing in combination with standard induction chemotherapy for de novo AML. The primary objectives are to determine the frequency of omission of atovaquone doses due to standard induction chemotherapy toxicity, to quantify the steady-state plasma levels of atovaquone, and to determine the time to achievement of steady state atovaquone levels in this population.

Conditions

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)

Sponsors & Collaborators

  • William Marsh Rice University

    collaborator OTHER

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Alexandra Stevens, MD · Baylor College of Medicine - Texas Children's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-10
Primary Completion
2020-09-29
Completion
2025-09-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03568994 on ClinicalTrials.gov