To learn if tasquinimod either alone or in combination with ruxolitinib can help to control PMF, post-PV MF, or post-ET MF.
Must be diagnosed with treatment requiring PMF or post ET/PV MF diagnosed according to the 2016 World Health Organization with intermediate -1, intermediate -2 or high-risk disease according to the DIPSS prognostic scoring system, or if with low risk disease then with symptomatic splenomegaly that is ≥ 5 cm below left costal margin by physical exam.
Peripheral or bone marrow blasts must be < 10%
Participants must provide written informed consent.
Age 18 years or older. Because no dosing or adverse event data are currently available on the use of tasquinimod as monotherapy or in combination with ruxolitinib in patients <18 years of age, children are excluded from this study.
For women of childbearing potential, a documented negative serum or urine pregnancy test within 14 days prior to the administration of study drug.
Postmenopausal (no menses in greater than or equal to 12 consecutive months).
History of hysterectomy or bilateral salpingo-oophorectomy.
Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
Single group
Ruxolitinib
DrugGiven by PO
Tasquinimod
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
Active Biotech AB
Collaborator
