A Phase I/II Study of Quizartinib in Combination With Decitabine and Venetoclax for the Treatment of Patients With Acute Myeloid Leukemia (AML)
M.D. Anderson Cancer Center
Summary
This phase I/II trial studies how well quizartinib, decitabine, and venetoclax work in treating participants with acute myeloid leukemia or high risk myelodysplastic syndrome that is untreated or has come back (relapsed). Quizartinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as decitabine and venetoclax, 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. Giving quizartinib and decitabine may work better at treating acute myeloid leukemia and myelodysplastic syndrome.
Description
PRIMARY OBJECTIVES: I. To determine the overall response rate (ORR) including CR (complete remission) + CRp (complete remission with incomplete platelet recovery) + CRi (complete remission with incomplete count recovery) + partial remission (PR) within 3 months of treatment initiation of quizartinib and decitabine + venetoclax combination in patients with newly diagnosed or relapsed acute myeloid leukemia (AML) or high risk myelodysplastic syndrome (MDS) (\> 10% blasts). II. To determine the safety and maximum tolerable dose (MTD) of this combination. SECONDARY OBJECTIVES: I. To determine…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosis of 1) AML (World Health Organization \[WHO\] classification definition of \>= 20% blasts) excluding acute promyelocytic leukemia (APL) or 2) MDS with \> 10% blasts (defined by the International Prognostic Scoring System \[IPSS\] classification). * For frontline Cohort: Patients aged \>= 60 years old who are not candidates for intensive induction therapy and agree to receive the proposed combination therapy will be enrolled. * Not considered candidates for intensive remission induction chemotherapy at time of enrollment based on EITHER: * 75 years of age OR…
Interventions
- DrugDecitabine
Given IV
- DrugQuizartinib
Given PO
- DrugVenetoclax
Given PO
Location
- M D Anderson Cancer CenterHouston, Texas