A Combination of Cladribine, Idarubicin, Cytarabine (CLIA) and Quizartinib for the Treatment of Patients With Newly Diagnosed or Relapsed/Refractory Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS))
M.D. Anderson Cancer Center
Summary
This phase I/II trial studies the side effects and how well cladribine, idarubicin, cytarabine, and quizartinib work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that is newly diagnosed, has come back (relapsed), or does not respond to treatment (refractory). Drugs used in chemotherapy, such as cladribine, idarubicin, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Quizartinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving quizartinib with cladribine, idarubicin, and cytarabine may help to control acute myeloid leukemia or high-risk myelodysplastic syndrome.
Description
PRIMARY OBJECTIVES: I. To determine the efficacy of quizartinib (AC220) in combination with cladribine, idarubicin and cytarabine (ara-C) induction chemotherapy in newly diagnosed or relapsed/refractory patients with high-risk myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). II. To determine the safety of the combination. SECONDARY OBJECTIVES: I. To determine the overall survival and disease-free survival of patients treated with this combination. II. To investigate correlations of response to this combination with a 81-gene panel of gene mutations both in patients with an…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosis of * AML (World Health Organization \[WHO\] classification definition of \>= 20% blasts, excluding Acute promyelocytic leukemia), * Acute biphenotypic leukemia or * High-risk MDS (\> 10% bone marrow blasts) * Frontline cohort: Patients aged 18 to 65 years * Relapse cohort: Patients aged \>=18 years old * Patients may be newly diagnosed (Frontline cohort) or with prior therapy (Relapsed cohort) as follows: * For frontline cohort: Patients must be chemonaive, i.e., not have received any chemotherapy (except hydroxyurea \[Hydrea\] \[no dose limit\], tret…
Interventions
- DrugCladribine
Given Intravenous
- DrugCytarabine
Given Intravenous
- DrugIdarubicin
Given Intravenous
- DrugQuizartinib
Given by mouth
Location
- M D Anderson Cancer CenterHouston, Texas