Atovaquone + Chemotherapy for Acute Myeloid Leukemia
(ATACC AML Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial allows prior use of certain medications like hydroxyurea and ATRA, but they cannot be taken at the same time as the trial treatment. The protocol does not specify about other medications, so it's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug combination including Atovaquone, Cytarabine, Daunorubicin, Etoposide, and Gemtuzumab Ozogamicin for treating Acute Myeloid Leukemia?
Research shows that a combination of Gemtuzumab Ozogamicin with Daunorubicin and Cytarabine has improved overall survival in patients with newly diagnosed acute myeloid leukemia compared to standard chemotherapy. Additionally, Vyxeos, a formulation of Daunorubicin and Cytarabine, demonstrated a significant survival benefit in high-risk AML patients.12345
What safety data exists for Atovaquone + Chemotherapy in treating Acute Myeloid Leukemia?
The combination of gemtuzumab ozogamicin (Mylotarg) with daunorubicin and cytarabine for acute myeloid leukemia has common side effects like bleeding and infection. Vyxeos, a combination of daunorubicin and cytarabine, shows side effects such as rash, fever, and low blood cell counts. Another combination with idarubicin, high-dose cytarabine, and etoposide was well-tolerated, with side effects like nausea and liver function changes.56789
What makes the drug Atovaquone combined with chemotherapy unique for treating acute myeloid leukemia?
This treatment is unique because it combines Atovaquone, a drug typically used for pneumonia, with standard chemotherapy to suppress energy production in leukemia cells, potentially enhancing the treatment's effectiveness. Atovaquone's ability to reduce leukemia burden by targeting oxidative phosphorylation (a process cells use to produce energy) is a novel approach in acute myeloid leukemia therapy.910111213
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.
Research Team
Alexandra Stevens, MD
Principal Investigator
Baylor College of Medicine - Texas Children's Hospital
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction Chemotherapy
Participants receive induction chemotherapy with cytarabine, daunorubicin, etoposide, and atovaquone
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Atovaquone
- Cytarabine
- Daunorubicin
- Etoposide
- Gemtuzumab Ozogamicin
Cytarabine is already approved in United States, European Union, Canada for the following indications:
- Acute myeloid leukemia
- Acute lymphocytic leukemia
- Chronic myeloid leukemia
- Meningeal leukemia
- Lymphomatous meningitis
- Acute myeloid leukemia
- Acute lymphocytic leukemia
- Chronic myeloid leukemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor College of Medicine
Lead Sponsor
William Marsh Rice University
Collaborator