ID

41525

Description

A Sequential Two-Stage Dose Escalation Study to Evaluate the Safety and Efficacy of Ruxolitinib; ODM derived from: https://clinicaltrials.gov/show/NCT01776723

Link

https://clinicaltrials.gov/show/NCT01776723

Keywords

Versions (1)
  1. 10/31/20 10/31/20 -
Copyright Holder

see on clinicaltrials.gov

Uploaded on

October 31, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Myelomonocytic Leukemia NCT01776723

English

Eligibility Myelomonocytic Leukemia NCT01776723

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed diagnosis of cmml using the world health organization (who) classification
Description

confirmed diagnosis of cmml using the world health organization (who) classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0023480
UMLS CUI [1,2]
C4267671
age >18 years at the time of obtaining informed consent
Description

age >18 years at the time of obtaining informed consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0021430
able to adhere to the study visit schedule and other protocol requirements
Description

ability to meet protocol requirements

Data type

boolean

Alias
UMLS CUI [1]
C0525058
must be able to provide adequate bone marrow (bm) aspirate and biopsy specimens for histopathological analysis and standard cytogenetic analysis during the screening procedure
Description

provide adequate bone marrow aspirate and biopsy specimens for histopathological analysis and standard cytogenetic analysis during the screening procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0205410
UMLS CUI [1,2]
C0857285
UMLS CUI [1,3]
C0677043
UMLS CUI [1,4]
C1710477
UMLS CUI [2,1]
C0205410
UMLS CUI [2,2]
C0857285
UMLS CUI [2,3]
C0752095
UMLS CUI [2,4]
C1710477
UMLS CUI [3,1]
C0205410
UMLS CUI [3,2]
C0005954
UMLS CUI [3,3]
C0677043
UMLS CUI [3,4]
C1710477
UMLS CUI [4,1]
C0205410
UMLS CUI [4,2]
C0005954
UMLS CUI [4,3]
C0752095
UMLS CUI [4,4]
C1710477
an eastern cooperative oncology group (ecog) performance status score of 0,1, or 2
Description

eastern cooperative oncology group (ecog) performance status score

Data type

boolean

Alias
UMLS CUI [1]
C1520224
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [1,3]
C1710477
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0427780
UMLS CUI [2,3]
C1442488
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C3858758
UMLS CUI [3,4]
C0521115
UMLS CUI [3,5]
C0750503
UMLS CUI [3,6]
C2347804
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0036899
UMLS CUI [4,3]
C0019421
UMLS CUI [4,4]
C0750503
UMLS CUI [4,5]
C2347804
must understand and voluntarily sign an informed consent form
Description

informed consent form

Data type

boolean

Alias
UMLS CUI [1]
C0021430
must have a life expectancy of greater than 3 months at time of screening
Description

life expectancy at time of screening

Data type

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C1710477
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
platelet count of less than 35,000/ul
Description

platelet count

Data type

boolean

Alias
UMLS CUI [1]
C0032181
absolute neutrophil count (anc) of less than 250/ul
Description

absolute neutrophil count (anc)

Data type

boolean

Alias
UMLS CUI [1]
C0948762
serum creatinine >2.0
Description

serum creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
serum total bilirubin >1.5 x upper limit of normal (uln)
Description

serum total bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C1278039
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
Description

use of cytotoxic chemotherapeutic agents, or experimental agents for the treatment of cmml around the start of the study drug treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C3854006
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C3854006
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
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C0021430
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C1883420
UMLS CUI [3,4]
C0035647
UMLS CUI [3,5]
C2348568
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C1883420
UMLS CUI [4,3]
C0035647
UMLS CUI [4,4]
C2348568
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0079460
UMLS CUI [2,1]
C0332300
UMLS CUI [2,2]
C0079459
UMLS CUI [2,3]
C0027947
UMLS CUI [2,4]
C3714514
UMLS CUI [3,1]
C0332300
UMLS CUI [3,2]
C0038317
UMLS CUI [3,3]
C0332185
UMLS CUI [4,1]
C0332300
UMLS CUI [4,2]
C1959590
UMLS CUI [4,3]
C0205360
UMLS CUI [4,4]
C0332185
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
Description

uncontrolled current illness including symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations limiting protocol compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0549178
UMLS CUI [2,2]
C3714514
UMLS CUI [3,1]
C0205177
UMLS CUI [3,2]
C3714514
UMLS CUI [4,1]
C0018802
UMLS CUI [4,2]
C0231220
UMLS CUI [5]
C0002965
UMLS CUI [6]
C0003811
UMLS CUI [7,1]
C0004936
UMLS CUI [7,2]
C0439801
UMLS CUI [7,3]
C0525058
UMLS CUI [8,1]
C0728831
UMLS CUI [8,2]
C0680082
UMLS CUI [8,3]
C0439801
UMLS CUI [8,4]
C0525058
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.
Description

pregnant and breastfeeding women are excluded from this study. Exception: Discontinuation of breastfeeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0332300
UMLS CUI [3,2]
C0006147
UMLS CUI [3,3]
C0457454
patients who have participated in other interventional (treatment-related) clinical trials within 30 days of enrollment are excluded.
Description

Recent participation in other interventional studies

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3274035
UMLS CUI [1,3]
C0332185
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Similar models

Eligibility Myelomonocytic Leukemia NCT01776723

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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