ID

37671

Descripción

Ruxolitinib Phosphate in Treating Patients With Chronic Neutrophilic Leukemia or Atypical Chronic Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT02092324

Link

https://clinicaltrials.gov/show/NCT02092324

Palabras clave

Versiones (1)
  1. 15/8/19 15/8/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

15 de agosto de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Atypical Chronic Myeloid Leukemia, Breakpoint Cluster Region-Abelson (BCR-ABL) 1 Negative NCT02092324

Inglés

Eligibility Atypical Chronic Myeloid Leukemia, Breakpoint Cluster Region-Abelson (BCR-ABL) 1 Negative NCT02092324

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
must be newly diagnosed or previously diagnosed with cnl or acml; all patients must have a bone marrow biopsy completed during the screening or baseline period if one has not been done within 90 days of day 1, cycle one
Descripción

Chronic Neutrophilic Leukemia | Leukemia, Myeloid, Chronic, Atypical | Bone marrow biopsy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023481
UMLS CUI [2]
C1292772
UMLS CUI [3]
C0005954
must have platelet count greater than 25,000 per microliter at baseline and at the start of study (day 1, cycle 1) visit
Descripción

Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032181
subjects must be able to discontinue any drug treatment aimed at lowering disease burden in cnl or acml; subjects should discontinue hydroxyurea to treat underlying cnl or acml disease no later than day -7 (one week before starting ruxolitinib); for drugs that have more long-lasting effects on the marrow, such as thalidomide and its analogs, and interferon, subjects should discontinue these no later than day -28
Descripción

Ability Pharmacotherapy Discontinue | Hydroxyurea To be stopped | ruxolitinib | Thalidomide To be stopped | Thalidomide Analog To be stopped | Interferon To be stopped

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0013216
UMLS CUI [1,3]
C1444662
UMLS CUI [2,1]
C0020402
UMLS CUI [2,2]
C1272691
UMLS CUI [3]
C2931926
UMLS CUI [4,1]
C0039736
UMLS CUI [4,2]
C1272691
UMLS CUI [5,1]
C3265467
UMLS CUI [5,2]
C1272691
UMLS CUI [6,1]
C3652465
UMLS CUI [6,2]
C1272691
subjects must be willing to accept/continue transfusions to treat low hemoglobin levels
Descripción

Transfusions Treating Low Hemoglobin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005841
UMLS CUI [1,2]
C1522326
UMLS CUI [1,3]
C0162119
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects unable to review and sign informed consent form
Descripción

Informed Consent Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
females who are pregnant or breastfeeding, and males and females who cannot comply with requirements to avoid fathering a child or becoming pregnant
Descripción

Pregnancy | Breast Feeding | Gender Contraceptive methods Absent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
subjects with known diagnosis of human immunodeficiency virus (hiv) or chronic active hepatitis b or c; viral testing is not required
Descripción

HIV Infection | Hepatitis B, Chronic | Hepatitis C, Chronic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0524909
UMLS CUI [3]
C0524910
subjects with inadequate liver (alanine aminotransferase (alt)/serum glutamate pyruvate transaminase (sgpt) above 4 x upper limit of normal (uln) or direct bilirubin 4 x uln and the lab abnormalities are felt to be due to underlying liver dysfunction)
Descripción

Liver Dysfunction | Alanine aminotransferase increased | Direct bilirubin increased

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0740434
subjects with end stage renal function (creatinine clearance (crcl) < 15 ml/min or glomerular filtration rate (gfr) <15 ml/min) regardless of whether hemodialysis is required
Descripción

Renal function End-stage | Creatinine clearance measurement | Glomerular Filtration Rate | Independent of Requirement Dialysis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0205088
UMLS CUI [2]
C0373595
UMLS CUI [3]
C0017654
UMLS CUI [4,1]
C0332291
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0011946
subjects with clinically serious infections requiring ongoing antibiotic therapy
Descripción

Communicable Diseases Serious | Requirement Antibiotic therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0338237
subjects with unstable/recent severe cardiac or pulmonary dysfunction, recent gastric or esophageal variceal bleeding, recent hemorrhagic strokes or intracranial bleeds; unstable is defined as medical issue requiring urgent intervention (hospitalization) or daily or weekly monitoring by medical personnel; recent is defined as within the last 3 months
Descripción

Cardiac dysfunction Unstable | Cardiac dysfunction Severe Recent | Pulmonary Dysfunction Unstable | Pulmonary Dysfunction Severe Recent | Gastric hemorrhage Recent | Bleeding esophageal varices Recent | Brain hemorrhage Recent | Intracranial Hemorrhages Recent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3277906
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C3277906
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0332185
UMLS CUI [3,1]
C1709770
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C1709770
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C0332185
UMLS CUI [5,1]
C0235325
UMLS CUI [5,2]
C0332185
UMLS CUI [6,1]
C0155789
UMLS CUI [6,2]
C0332185
UMLS CUI [7,1]
C0553692
UMLS CUI [7,2]
C0332185
UMLS CUI [8,1]
C0151699
UMLS CUI [8,2]
C0332185
subjects requiring therapeutic doses of anticoagulation or anti-platelet therapies (aspirin above 81 mg daily, plavix or similar agents) and platelet counts are below 50,000 on two different laboratory evaluations, separated by minimum of two weeks
Descripción

Anticoagulation Therapy Dose Therapeutic | Antiplatelet therapy Dose Therapeutic | Aspirin U/day | Plavix | Pharmaceutical Preparations Similar | Platelet Count measurement Evaluation Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0302350
UMLS CUI [2,1]
C1096021
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0302350
UMLS CUI [3,1]
C0004057
UMLS CUI [3,2]
C0456683
UMLS CUI [4]
C0633084
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C2348205
UMLS CUI [6,1]
C0032181
UMLS CUI [6,2]
C1261322
UMLS CUI [6,3]
C1265611
taking investigational or commercial agents or therapies with the intent to treat the subject's malignancy other than those therapies permitted
Descripción

Investigational New Drugs Cancer treatment | Investigational Therapies Cancer treatment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0920425
UMLS CUI [2,1]
C0949266
UMLS CUI [2,2]
C0920425
subjects with invasive malignancy over the previous 2 years except treated early stage carcinomas of the skin, completely resected intraepithelial carcinoma of the cervix, and completely resected papillary thyroid and follicular thyroid cancers
Descripción

invasive cancer | Exception Skin carcinoma Early stage Treated | Exception Complete excision Intraepithelial carcinoma of the cervix | Exception Complete excision Papillary thyroid carcinoma | Exception Complete excision Follicular thyroid carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C2363430
UMLS CUI [2,4]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0015250
UMLS CUI [3,3]
C0848737
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0015250
UMLS CUI [4,3]
C0238463
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0015250
UMLS CUI [5,3]
C0206682
previous allergic reactions to janus kinase (jak) inhibitors or excipients
Descripción

Allergic Reaction Janus kinase inhibitor | Allergic Reaction Janus kinase inhibitor Excipient

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C3854325
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C3854325
UMLS CUI [2,3]
C0015237
prior therapy with ruxolitinib or other jak inhibitors
Descripción

Prior Therapy Ruxolitinib | Prior Therapy Janus kinase inhibitor

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C2931926
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C3854325
subjects who have had major surgery within 4 weeks prior to entering the study
Descripción

Major surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0679637
subjects who are anticipated to receive a transplant within the first 6 months of treatment on trial
Descripción

Transplantation Anticipated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0040732
UMLS CUI [1,2]
C3840775
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Similar models

Eligibility Atypical Chronic Myeloid Leukemia, Breakpoint Cluster Region-Abelson (BCR-ABL) 1 Negative NCT02092324

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Neutrophilic Leukemia | Leukemia, Myeloid, Chronic, Atypical | Bone marrow biopsy
Item
must be newly diagnosed or previously diagnosed with cnl or acml; all patients must have a bone marrow biopsy completed during the screening or baseline period if one has not been done within 90 days of day 1, cycle one
boolean
C0023481 (UMLS CUI [1])
C1292772 (UMLS CUI [2])
C0005954 (UMLS CUI [3])
Platelet Count measurement
Item
must have platelet count greater than 25,000 per microliter at baseline and at the start of study (day 1, cycle 1) visit
boolean
C0032181 (UMLS CUI [1])
Ability Pharmacotherapy Discontinue | Hydroxyurea To be stopped | ruxolitinib | Thalidomide To be stopped | Thalidomide Analog To be stopped | Interferon To be stopped
Item
subjects must be able to discontinue any drug treatment aimed at lowering disease burden in cnl or acml; subjects should discontinue hydroxyurea to treat underlying cnl or acml disease no later than day -7 (one week before starting ruxolitinib); for drugs that have more long-lasting effects on the marrow, such as thalidomide and its analogs, and interferon, subjects should discontinue these no later than day -28
boolean
C0085732 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C1444662 (UMLS CUI [1,3])
C0020402 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
C2931926 (UMLS CUI [3])
C0039736 (UMLS CUI [4,1])
C1272691 (UMLS CUI [4,2])
C3265467 (UMLS CUI [5,1])
C1272691 (UMLS CUI [5,2])
C3652465 (UMLS CUI [6,1])
C1272691 (UMLS CUI [6,2])
Transfusions Treating Low Hemoglobin
Item
subjects must be willing to accept/continue transfusions to treat low hemoglobin levels
boolean
C0005841 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0162119 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unable
Item
subjects unable to review and sign informed consent form
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Gender Contraceptive methods Absent
Item
females who are pregnant or breastfeeding, and males and females who cannot comply with requirements to avoid fathering a child or becoming pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
HIV Infection | Hepatitis B, Chronic | Hepatitis C, Chronic
Item
subjects with known diagnosis of human immunodeficiency virus (hiv) or chronic active hepatitis b or c; viral testing is not required
boolean
C0019693 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
C0524910 (UMLS CUI [3])
Liver Dysfunction | Alanine aminotransferase increased | Direct bilirubin increased
Item
subjects with inadequate liver (alanine aminotransferase (alt)/serum glutamate pyruvate transaminase (sgpt) above 4 x upper limit of normal (uln) or direct bilirubin 4 x uln and the lab abnormalities are felt to be due to underlying liver dysfunction)
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0740434 (UMLS CUI [3])
Renal function End-stage | Creatinine clearance measurement | Glomerular Filtration Rate | Independent of Requirement Dialysis
Item
subjects with end stage renal function (creatinine clearance (crcl) < 15 ml/min or glomerular filtration rate (gfr) <15 ml/min) regardless of whether hemodialysis is required
boolean
C0232804 (UMLS CUI [1,1])
C0205088 (UMLS CUI [1,2])
C0373595 (UMLS CUI [2])
C0017654 (UMLS CUI [3])
C0332291 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0011946 (UMLS CUI [4,3])
Communicable Diseases Serious | Requirement Antibiotic therapy
Item
subjects with clinically serious infections requiring ongoing antibiotic therapy
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0338237 (UMLS CUI [2,2])
Cardiac dysfunction Unstable | Cardiac dysfunction Severe Recent | Pulmonary Dysfunction Unstable | Pulmonary Dysfunction Severe Recent | Gastric hemorrhage Recent | Bleeding esophageal varices Recent | Brain hemorrhage Recent | Intracranial Hemorrhages Recent
Item
subjects with unstable/recent severe cardiac or pulmonary dysfunction, recent gastric or esophageal variceal bleeding, recent hemorrhagic strokes or intracranial bleeds; unstable is defined as medical issue requiring urgent intervention (hospitalization) or daily or weekly monitoring by medical personnel; recent is defined as within the last 3 months
boolean
C3277906 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C3277906 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
C1709770 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C1709770 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0332185 (UMLS CUI [4,3])
C0235325 (UMLS CUI [5,1])
C0332185 (UMLS CUI [5,2])
C0155789 (UMLS CUI [6,1])
C0332185 (UMLS CUI [6,2])
C0553692 (UMLS CUI [7,1])
C0332185 (UMLS CUI [7,2])
C0151699 (UMLS CUI [8,1])
C0332185 (UMLS CUI [8,2])
Anticoagulation Therapy Dose Therapeutic | Antiplatelet therapy Dose Therapeutic | Aspirin U/day | Plavix | Pharmaceutical Preparations Similar | Platelet Count measurement Evaluation Quantity
Item
subjects requiring therapeutic doses of anticoagulation or anti-platelet therapies (aspirin above 81 mg daily, plavix or similar agents) and platelet counts are below 50,000 on two different laboratory evaluations, separated by minimum of two weeks
boolean
C0003281 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0302350 (UMLS CUI [1,3])
C1096021 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0302350 (UMLS CUI [2,3])
C0004057 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C0633084 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C2348205 (UMLS CUI [5,2])
C0032181 (UMLS CUI [6,1])
C1261322 (UMLS CUI [6,2])
C1265611 (UMLS CUI [6,3])
Investigational New Drugs Cancer treatment | Investigational Therapies Cancer treatment
Item
taking investigational or commercial agents or therapies with the intent to treat the subject's malignancy other than those therapies permitted
boolean
C0013230 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0949266 (UMLS CUI [2,1])
C0920425 (UMLS CUI [2,2])
invasive cancer | Exception Skin carcinoma Early stage Treated | Exception Complete excision Intraepithelial carcinoma of the cervix | Exception Complete excision Papillary thyroid carcinoma | Exception Complete excision Follicular thyroid carcinoma
Item
subjects with invasive malignancy over the previous 2 years except treated early stage carcinomas of the skin, completely resected intraepithelial carcinoma of the cervix, and completely resected papillary thyroid and follicular thyroid cancers
boolean
C0677898 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C2363430 (UMLS CUI [2,3])
C1522326 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0015250 (UMLS CUI [3,2])
C0848737 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0015250 (UMLS CUI [4,2])
C0238463 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0015250 (UMLS CUI [5,2])
C0206682 (UMLS CUI [5,3])
Allergic Reaction Janus kinase inhibitor | Allergic Reaction Janus kinase inhibitor Excipient
Item
previous allergic reactions to janus kinase (jak) inhibitors or excipients
boolean
C1527304 (UMLS CUI [1,1])
C3854325 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C3854325 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Prior Therapy Ruxolitinib | Prior Therapy Janus kinase inhibitor
Item
prior therapy with ruxolitinib or other jak inhibitors
boolean
C1514463 (UMLS CUI [1,1])
C2931926 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C3854325 (UMLS CUI [2,2])
Major surgery
Item
subjects who have had major surgery within 4 weeks prior to entering the study
boolean
C0679637 (UMLS CUI [1])
Transplantation Anticipated
Item
subjects who are anticipated to receive a transplant within the first 6 months of treatment on trial
boolean
C0040732 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
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