confirmed diagnosis of cmml using the world health organization (who) classification
Item
confirmed diagnosis of cmml using the world health organization (who) classification
boolean
C0023480 (UMLS CUI [1,1])
C4267671 (UMLS CUI [1,2])
age >18 years at the time of obtaining informed consent
Item
age >18 years at the time of obtaining informed consent
boolean
C0001779 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
ability to meet protocol requirements
Item
able to adhere to the study visit schedule and other protocol requirements
boolean
C0525058 (UMLS CUI [1])
provide adequate bone marrow aspirate and biopsy specimens for histopathological analysis and standard cytogenetic analysis during the screening procedure
Item
must be able to provide adequate bone marrow (bm) aspirate and biopsy specimens for histopathological analysis and standard cytogenetic analysis during the screening procedure
boolean
C0205410 (UMLS CUI [1,1])
C0857285 (UMLS CUI [1,2])
C0677043 (UMLS CUI [1,3])
C1710477 (UMLS CUI [1,4])
C0205410 (UMLS CUI [2,1])
C0857285 (UMLS CUI [2,2])
C0752095 (UMLS CUI [2,3])
C1710477 (UMLS CUI [2,4])
C0205410 (UMLS CUI [3,1])
C0005954 (UMLS CUI [3,2])
C0677043 (UMLS CUI [3,3])
C1710477 (UMLS CUI [3,4])
C0205410 (UMLS CUI [4,1])
C0005954 (UMLS CUI [4,2])
C0752095 (UMLS CUI [4,3])
C1710477 (UMLS CUI [4,4])
eastern cooperative oncology group (ecog) performance status score
Item
an eastern cooperative oncology group (ecog) performance status score of 0,1, or 2
boolean
C1520224 (UMLS CUI [1])
women of childbearing potential must have a negative pregnancy test at time of screening and baseline visits and agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse around the clinical trial period
Item
women of childbearing potential must have a negative pregnancy test at time of screening and baseline visits and agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
C1442488 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C3858758 (UMLS CUI [3,3])
C0521115 (UMLS CUI [3,4])
C0750503 (UMLS CUI [3,5])
C2347804 (UMLS CUI [3,6])
C3831118 (UMLS CUI [4,1])
C0036899 (UMLS CUI [4,2])
C0019421 (UMLS CUI [4,3])
C0750503 (UMLS CUI [4,4])
C2347804 (UMLS CUI [4,5])
informed consent form
Item
must understand and voluntarily sign an informed consent form
boolean
C0021430 (UMLS CUI [1])
life expectancy at time of screening
Item
must have a life expectancy of greater than 3 months at time of screening
boolean
C0023671 (UMLS CUI [1,1])
C1710477 (UMLS CUI [1,2])
platelet count
Item
platelet count of less than 35,000/ul
boolean
C0032181 (UMLS CUI [1])
absolute neutrophil count (anc)
Item
absolute neutrophil count (anc) of less than 250/ul
boolean
C0948762 (UMLS CUI [1])
serum creatinine
Item
serum creatinine >2.0
boolean
C0201976 (UMLS CUI [1])
serum total bilirubin
Item
serum total bilirubin >1.5 x upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
use of cytotoxic chemotherapeutic agents, or experimental agents for the treatment of cmml around the start of the study drug treatment
Item
use of cytotoxic chemotherapeutic agents, or experimental agents (agents that are not commercially available) for the treatment of cmml within 28 days of the first day of study drug treatment
boolean
C0677881 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C3854006 (UMLS CUI [2,3])
any serious medical condition or psychiatric illness preventing the subject from signing the informed consent form or placing the subject at unacceptable risk in case of study participation
Item
any serious medical condition or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he/she participates in the study
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C1883420 (UMLS CUI [3,3])
C0035647 (UMLS CUI [3,4])
C2348568 (UMLS CUI [3,5])
C0004936 (UMLS CUI [4,1])
C1883420 (UMLS CUI [4,2])
C0035647 (UMLS CUI [4,3])
C2348568 (UMLS CUI [4,4])
concurrent use of granulocyte/macrophage colony stimulating factor (gm-csf). Exceptions: granulocyte colony-stimulating factor (g-csf) used for short-term management of neutropenic infection, stable doses of erythropoietin stimulating agents or corticosteroids administered recently
Item
concurrent use of granulocyte/macrophage colony stimulating factor (gm-csf). granulocyte colony-stimulating factor (g-csf) could be used for the short-term management of neutropenic infection. stable doses of erythropoietin stimulating agents that were started >8 weeks from first ruxolitinib dose or corticosteroids that were being administered prior to screening are allowed.
boolean
C2347852 (UMLS CUI [1,1])
C0079460 (UMLS CUI [1,2])
C0332300 (UMLS CUI [2,1])
C0079459 (UMLS CUI [2,2])
C0027947 (UMLS CUI [2,3])
C3714514 (UMLS CUI [2,4])
C0332300 (UMLS CUI [3,1])
C0038317 (UMLS CUI [3,2])
C0332185 (UMLS CUI [3,3])
C0332300 (UMLS CUI [4,1])
C1959590 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
C0332185 (UMLS CUI [4,4])
uncontrolled current illness including symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations limiting protocol compliance
Item
uncontrolled current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0549178 (UMLS CUI [2,1])
C3714514 (UMLS CUI [2,2])
C0205177 (UMLS CUI [3,1])
C3714514 (UMLS CUI [3,2])
C0018802 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
C0002965 (UMLS CUI [5])
C0003811 (UMLS CUI [6])
C0004936 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
C0728831 (UMLS CUI [8,1])
C0680082 (UMLS CUI [8,2])
C0439801 (UMLS CUI [8,3])
C0525058 (UMLS CUI [8,4])
pregnant and breastfeeding women are excluded from this study. Exception: Discontinuation of breastfeeding
Item
pregnant women are excluded from this study because ruxolitinib has not been studied in pregnant subjects. because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ruxolitinib, breastfeeding should be discontinued if the mother is treated with ruxolitinib.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0332300 (UMLS CUI [3,1])
C0006147 (UMLS CUI [3,2])
C0457454 (UMLS CUI [3,3])
Recent participation in other interventional studies
Item
patients who have participated in other interventional (treatment-related) clinical trials within 30 days of enrollment are excluded.
boolean
C2348568 (UMLS CUI [1,1])
C3274035 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])