Atovaquone + Chemotherapy for Acute Myeloid Leukemia
(ATACC AML Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byAlexandra Stevens, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Baylor College of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for children over 1 month and young adults under 21 with newly diagnosed acute myeloid leukemia (AML) that hasn't been treated before. They must have specific genetic abnormalities or a certain percentage of bone marrow blasts, among other criteria. Those who've had extensive prior anthracycline treatment, are pregnant or breastfeeding, or have certain genetic conditions like Fanconi anemia aren't eligible.

Inclusion Criteria

I have AML with more than 20% bone marrow blasts, as per WHO guidelines.

My leukemia has specific genetic features or less than 20% immature blood cells.

My myelodysplastic syndrome has progressed to acute myeloid leukemia.

+6 more

Exclusion Criteria

I am currently pregnant.

Lactating females unless they have agreed not to breastfeed their infants

I have AML and have been treated with high doses of anthracyclines.

+6 more

Participant Groups

The study tests atovaquone combined with standard chemotherapy drugs (Daunorubicin, Gemtuzumab Ozogamicin, Etoposide, Cytarabine) in treating new cases of AML. It aims to see how often atovaquone doses are missed due to chemo side effects and measure the levels and timing of atovaquone in the blood during treatment.

2Treatment groups

Experimental Treatment

Group I: DA 3+10 with GO plus AQExperimental Treatment4 Interventions

Induction I DA: daunorubicin, cytarabine 3+10 with GO: gemtuzumab ozogamicin, atovaquone daily

Group II: ADE 10+3+5 plus Atovaquone (AQ)Experimental Treatment4 Interventions

Induction I ADE: cytarabine, daunorubicin, etoposide 10+3+5, atovaquone daily

Cytarabine is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Cytosar-U for: