To learn the recommended dose of momelotinib that can be given in combination with gilteritinib to participants with AML.
Performance status ≤3 (ECOG Scale).
Total serum bilirubin ≤ 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the PI
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3 x ULN, unless due to the underlying leukemia approved by the PI
Willingness to use adequate contraception prior to study entry, for the duration of study participation, and for 4 months after completion of study participation. For women of childbearing potential, adequate methods of contraception include: complete abstinence, hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device (IUD), tubal Ligation or hysterectomy, participants/partner post vasectomy, implantable or injectable contraceptives, and condoms plus spermicide
Congenital long QT syndrome or QTcF >450 msec. Repeat EKGs after correction of electrolytes or discontinuation of QT prolonging medications are allowed to meet entry criteria. In cases where QTcF >450 msec is considered to be falsely increased due to inaccurate automated reading and not clinically significant (e.g. due to bundle branch block), participants are still eligible if cardiologist reviews and documents that QTcF is ≤ 450 msec when manually measured.
Active serious infection not controlled by oral or intravenous antibiotics (e.g. persistent fever or lack of improvement despite antimicrobial treatment).
Active Class III-V cardiac failure as defined by the New York Heart Association Functional Classification.
Active central nervous system leukemia
Single group
Gilteritinib
DrugGiven by PO
Momelotinib
DrugGiven by PO
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
GlaxoSmithKline
Collaborator
