drugset / Trial / NCT03568994
Atovaquone (Mepron®) Combined With Conventional Chemotherapy for de Novo Acute Myeloid Leukemia (AML)
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2018-07-10
- Primary completion
- 2020-09-29
- Completion
- 2025-09-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atovaquone | Small molecule | — | — |
| Background | Cytarabine | Small molecule | — | — |
| Background | Daunorubicin | Small molecule | — | — |
| Background | Etoposide | Small molecule | — | — |
| Background | Gemtuzumab Ozogamicin | Monoclonal antibody | — | — |