Cytarabine With or Without SCH 900776 in Treating Adult Patients With Relapsed Acute Myeloid Leuk… (NCT01870596) | Clinical Trial Compass
CompletedPhase 2
Cytarabine With or Without SCH 900776 in Treating Adult Patients With Relapsed Acute Myeloid Leukemia
United States32 participantsStarted 2013-05
Plain-language summary
This randomized phase II trial studies how well cytarabine with or without SCH 900776 works in treating adult patients with relapsed acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or stopping them from dividing. SCH 900776 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether cytarabine is more effective with or without SCH 900776 in treating acute myeloid leukemia.
Who can participate
Age range18 Years – 75 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:
* Adults with the established, pathologically confirmed diagnosis of relapsed AML
* AML that has relapsed at least once or is primary induction failure
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Patients must be able to give informed consent
* Female patients of childbearing age must have negative pregnancy test
* Serum creatinine =\< 2.0 mg/dl
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 5 x upper limit normal (ULN), unless due to Gilbert's, hemolysis or leukemic infiltration
* Alkaline phosphatase =\< 5 x ULN, unless due to Gilbert's, hemolysis or leukemic infiltration
* Bilirubin =\< 2.0 mg/dl, unless due to Gilbert's, hemolysis or leukemic infiltration
* Left ventricular ejection fraction \>= 45% by multi gated acquisition scan (MUGA) or echocardiogram
* Baseline Fridericia corrected QT (QTcF) \< 480 msec
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 30 days after study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
* Patients who have undergone stem cell transplantation (SCT), autologous or allogeneic, are eligible provided that they are \>= 4 weeks from stem cell infusion, have no active graft-vs-host disease (GVHD), and meet other eligibility criteria
* Patien…