Vosaroxin and Infusional Cytarabine in Treating Patients With Untreated Acute Myeloid Leukemia (NCT02658487) | Clinical Trial Compass
CompletedPhase 2
Vosaroxin and Infusional Cytarabine in Treating Patients With Untreated Acute Myeloid Leukemia
United States42 participantsStarted 2016-03
Plain-language summary
This phase II trial studies how well vosaroxin and cytarabine work in treating patients with untreated acute myeloid leukemia. Drugs used in chemotherapy, such as vosaroxin 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Ability to provide informed consent
* Ability to tolerate intensive therapy with vosaroxin 90 mg/m\^2 and cytarabine
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 at time of study entry
* Morphologically confirmed new diagnosis of AML in accordance with World Health Organization (WHO) diagnostic criteria
* Patients who have received hydroxyurea alone or have previously received "non-cytotoxic" therapies for myelodysplastic syndromes (MDS) or myeloproliferative neoplasms (MPN) (e.g., thalidomide or lenalidomide, 5-azacytidine or decitabine, histone deacetylase inhibitors, low-dose Cytoxan, tyrosine kinase or dual tyrosine kinase \[TK\]/SRC proto-oncogene, non-receptor tyrosine kinase \[src\] inhibitors) will be allowed
* Serum creatinine =\< 2.0 mg/dL
* Hepatic enzymes (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\]) =\< 2.5 x upper limit of normal
* Total bilirubin =\< 1.5 x upper limit of normal unless clearly related to Gilbert's disease, hemolysis or leukemic infiltrate
* FOR PATIENTS IN STAGE 1 (PATIENTS #1-#17)
* \>= 55 years of age with AML of any risk classification, or 18-54 years of age with high-risk AML disease based on one of the following:
* Antecedent hematologic disorder including myelodysplasia (MDS)-related AML (MDS/AML) and prior myeloproliferative disorder (MPD)
* Treatment-related myeloid neoplasms (t-AML/t-MDS)
* AML with FMS-like tyrosine kinase 3 (FLT3) - internal tandem duplicatio…