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NCT03568994 · ClinicalTrials.gov registry record · Early Phase 1
Atovaquone (Mepron®) Combined With Conventional Chemotherapy for de Novo Acute Myeloid Leukemia (AML)
A Early Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 26
- Enrollment target
NCT03568994: Completed Early Phase 1 study, sponsored by Baylor College of Medicine.
NCT03568994 is a Early Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 26 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03568994, a Early Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 26 participants
- Enrollment target
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.
Primary Outcome
The investigators will determine plasma levels of atovaquone at the following time points: Day 6, 11, 13, 15, 18, 20, 22, 29 and on the day of the end of induction bone marrow (BM) assessment (generally around Day 36).
Interventions
- DRUG Gemtuzumab Ozogamicin
- DRUG Etoposide
- DRUG Cytarabine
- DRUG Daunorubicin
- DRUG Atovaquone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2018-07-10 |
| Est. Completion | 2025-09-20 |
| Phase | Early Phase 1 |
What the finished NCT03568994 record still lists
NCT03568994 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 5 interventions - of which Gemtuzumab Ozogamicin is the first listed.
NCT03568994 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03568994 about?
NCT03568994 is a clinical study titled "Atovaquone (Mepron®) Combined With Conventional Chemotherapy for de Novo Acute Myeloid Leukemia (AML)". 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...
What is the current status of trial NCT03568994?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 26 participants. The study started on 2018-07-10. Estimated completion is 2025-09-20.
What interventions are being tested in trial NCT03568994?
The interventions under investigation include: Gemtuzumab Ozogamicin (DRUG), Etoposide (DRUG), Cytarabine (DRUG), Daunorubicin (DRUG), Atovaquone (DRUG).
Who is sponsoring clinical trial NCT03568994?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03568994's enrollment target sits among peer trials
26 977th of 2000 higher than 1,002 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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