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Antimetabolite

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

Phase < 1
Waitlist Available
Led By Alexandra Stevens, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with previously untreated primary AML who meet the customary criteria for AML with ≥ 20% bone marrow blasts as set out in the 2008 World Health Organization (WHO) Myeloid Neoplasm Classification are eligible
Patients with a history of myelodysplastic syndrome that has progressed to AML which meets the criteria above are eligible
Must not have
Female patients who are pregnant
Patients with treatment-related AML who have received more than 250mg/m2 of anthracyclines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if a daily dose of atovaquone, combined with standard chemotherapy for AML, is safe and effective.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include those from standard chemotherapy such as nausea, vomiting, hair loss, increased risk of infection due to low blood cell counts; plus any specific reactions to atovaquone which could be digestive issues or rashes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have AML with more than 20% bone marrow blasts, as per WHO guidelines.
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My myelodysplastic syndrome has progressed to acute myeloid leukemia.
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I have been recently diagnosed with acute myelogenous leukemia.
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I can take medicine by mouth or feeding tube.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently pregnant.
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I have AML and have been treated with high doses of anthracyclines.
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I have a genetic condition affecting my bone marrow.
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I do not have any other cancers or specific types of leukemia.
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I am not pregnant or have a negative pregnancy test if of childbearing age.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose Omission Frequency
Plasma Concentrations
Time to Achieve Steady State

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atovaquone
2012
Completed Phase 1
~80
Daunorubicin
2013
Completed Phase 4
~5040
Etoposide
2010
Completed Phase 3
~2960
Gemtuzumab Ozogamicin
2006
Completed Phase 4
~440
Cytarabine
2016
Completed Phase 3
~3330

Find a Location

Who is running the clinical trial?

William Marsh Rice UniversityOTHER
47 Previous Clinical Trials
28,129 Total Patients Enrolled
Baylor College of MedicineLead Sponsor
1,022 Previous Clinical Trials
6,029,394 Total Patients Enrolled
Alexandra Stevens, MDPrincipal InvestigatorBaylor College of Medicine - Texas Children's Hospital

Media Library

Cytarabine (Antimetabolite) Clinical Trial Eligibility Overview. Trial Name: NCT03568994 — Phase < 1
Acute Myeloid Leukemia Research Study Groups: ADE 10+3+5 plus Atovaquone (AQ), DA 3+10 with GO plus AQ
Acute Myeloid Leukemia Clinical Trial 2023: Cytarabine Highlights & Side Effects. Trial Name: NCT03568994 — Phase < 1
Cytarabine (Antimetabolite) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03568994 — Phase < 1
~4 spots leftby Nov 2025
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