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ATACC AML: Atovaquone (Mepron®) Combined With Conventional Chemotherapy for de Novo Acute Myeloid Leukemia (AML)

Diseases

Patients must have Acute Myeloid Leukemia (AML).

Description

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. Standard cytotoxic chemotherapy is based on the Medical Research Council (MRC) backbone of cytarabine, and daunorubicin. This combination of chemotherapy is highly myelosuppressive and can lead to oral aversions, dietary intolerance, and gastrointestinal infections necessitating holding of oral drugs. Because of the toxicity of the best currently available therapy, new drugs that are considered for incorporation into existing treatment regimens will ideally have a tolerable side effect profile. This study will evaluate the tolerability of incorporating the orally bioavailable drug atovaquone in combination with standard cytotoxic induction chemotherapy for newly diagnosed pediatric AML patients. Therefore, quantifying the frequency with which atovaquone is held due to a side effect of therapy is crucial information to gather in this population.

Eligibility Criteria

  • Ages eligible for study: 1 month to 20 years (Child, Adult)
  • Diagnosis: Patients must be newly diagnosed with acute myelogenous leukemia
  • Patients with a history of myelodysplastic syndrome that has progressed to AML which meets the criteria above are eligible.
  • Therapy-related or secondary AML Patients with AML which is thought to be therapy related but meet the criteria above are eligible.
  • Prior therapy with hydroxyurea, all-trans retinoic acid (ATRA), corticosteroids (any route), and IT cytarabine given at diagnosis is allowed. Hydroxyurea and ATRA cannot be given concurrently with protocol therapy. There is no specific amount of time mandated between the last dose of hydroxyurea or ATRA and the start of protocol therapy. With the exception of infants who had previously received low dose cytarabine to control disease, patients who have previously received any other antileukemic therapy (i.e. chemotherapy or radiation therapy) are not eligible for this protocol.
  • Adequate Liver Function
  • Ability to receive enteral medication

Detailed inclusion and exclusion criteria as listed on clinicaltrials.gov.

Contact

Alexandra Stevens, MD
Principal Investigator
Texas Children’s Cancer and Hematology Centers

or

Diana Montesinos
dpmontes@txch.org
832-824-6838