ID

35326

Beschreibung

Ruxolitinib in the Treatment of Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT02015208

Link

https://clinicaltrials.gov/show/NCT02015208

Stichworte

Versionen (1)
  1. 28.02.19 28.02.19 -
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See clinicaltrials.gov

Hochgeladen am

28. Februar 2019

DOI

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Eligibility Chronic Lymphocytic Leukemia NCT02015208

Englisch

Eligibility Chronic Lymphocytic Leukemia NCT02015208

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age greater than 65 years unless a 17p deletion by fish analysis is present in more than 20% of circulating tumor cells, in which case age can be younger than 65 years.
Beschreibung

Age | Exception 17p Deletion Circulating Tumor Cell Count FISH

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1517965
UMLS CUI [2,3]
C3272887
UMLS CUI [2,4]
C0162789
2. diagnosis of cll meeting published diagnostic criteria.
Beschreibung

Chronic Lymphocytic Leukemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0023434
3. cll requiring treatment on the basis of national cancer institute (nci) working group criteria.
Beschreibung

Chronic Lymphocytic Leukemia Treatment required for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C0332121
4. not previously treated with cytotoxic drugs or antibodies but may have received glucocorticoid monotherapy, local radiation, or splenectomy.
Beschreibung

Cytotoxic agent Absent | Antibodies Absent | Glucocorticoid therapy | Therapeutic radiology procedure Local | Splenectomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304497
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0003241
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0744425
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0205276
UMLS CUI [5]
C0037995
5. unfit for full dose fcr chemotherapy.
Beschreibung

Patients Medically unfit | Cyclophosphamide/fludarabine/rituximab Dose Full

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3841806
UMLS CUI [2,1]
C1327865
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0443225
6. platelets >50x10**9/l. neutrophils>.75x10**9/l.
Beschreibung

Platelet Count measurement | Neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C0200633
7. at least 1 lymph node >1.5 cm or splenomegaly as detected by ct scan.
Beschreibung

Size of lymph node CT scan | Splenomegaly CT scan

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1285847
UMLS CUI [1,2]
C0040405
UMLS CUI [2,1]
C0038002
UMLS CUI [2,2]
C0040405
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. fit for full-dose fcr as initial treatment.
Beschreibung

Patients Fit | Cyclophosphamide/fludarabine/rituximab Dose Full

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0424576
UMLS CUI [2,1]
C1327865
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0443225
2. progressive multifocal leukoencephalopathy (pml).
Beschreibung

Leukoencephalopathy, Progressive Multifocal

Datentyp

boolean

Alias
UMLS CUI [1]
C0023524
3. clinically significant bacterial, fungal, parasitic or viral infection, which require therapy.
Beschreibung

Bacterial Infection Treatment required for | Mycoses Treatment required for | Parasitic infection Treatment required for | Virus Disease Treatment required for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C0026946
UMLS CUI [2,2]
C0332121
UMLS CUI [3,1]
C0747256
UMLS CUI [3,2]
C0332121
UMLS CUI [4,1]
C0042769
UMLS CUI [4,2]
C0332121
4. richter's transformation or prolymphocytic leukemia.
Beschreibung

Richter's syndrome | Prolymphocytic Leukemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0349631
UMLS CUI [2]
C0023486
5. uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura.
Beschreibung

Autoimmune hemolytic anemia Uncontrolled | Idiopathic thrombocytopenia purpura Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002880
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0398650
UMLS CUI [2,2]
C0205318
6. prior exposure to chemotherapy for cll with the exception of glucocorticoids, local radiation, or splenectomy.
Beschreibung

Chemotherapy Chronic Lymphocytic Leukemia | Exception Glucocorticoids | Exception Therapeutic radiology procedure Local | Exception Splenectomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0023434
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0017710
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1522449
UMLS CUI [3,3]
C0205276
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0037995
7. history of prior malignancy, with the exception of the following: i. malignancy treated with curative intent and with no evidence of active disease for more than 2 years. ii. adequately treated skin cancer. iii. adequately treated cervical carcinoma in situ.
Beschreibung

Malignant Neoplasms | Exception Curative treatment Malignant Neoplasms | Exception Disease Free Duration | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0006826
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0332296
UMLS CUI [3,4]
C0449238
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0699893
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0851140
UMLS CUI [5,3]
C1522326
8. currently active clinically significant cardiovascular disease.
Beschreibung

Cardiovascular Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
9. history of stroke or intracranial hemorrhage within 6 months prior to enrollment.
Beschreibung

Cerebrovascular accident | Intracranial Hemorrhages

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0151699
10. renal failure requiring dialysis and patients with moderate and severe renal impairment with platelet counts less than 100,000/ml.
Beschreibung

Kidney Failure Requirement Dialysis | Renal Insufficiency Moderate | Renal Insufficiency Severe | Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0011946
UMLS CUI [2,1]
C1565489
UMLS CUI [2,2]
C0205081
UMLS CUI [3,1]
C1565489
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0032181
11. hepatic impairment.
Beschreibung

Hepatic impairment

Datentyp

boolean

Alias
UMLS CUI [1]
C0948807
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Ähnliche Modelle

Eligibility Chronic Lymphocytic Leukemia NCT02015208

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Exception 17p Deletion Circulating Tumor Cell Count FISH
Item
1. age greater than 65 years unless a 17p deletion by fish analysis is present in more than 20% of circulating tumor cells, in which case age can be younger than 65 years.
boolean
C0001779 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1517965 (UMLS CUI [2,2])
C3272887 (UMLS CUI [2,3])
C0162789 (UMLS CUI [2,4])
Chronic Lymphocytic Leukemia
Item
2. diagnosis of cll meeting published diagnostic criteria.
boolean
C0023434 (UMLS CUI [1])
Chronic Lymphocytic Leukemia Treatment required for
Item
3. cll requiring treatment on the basis of national cancer institute (nci) working group criteria.
boolean
C0023434 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Cytotoxic agent Absent | Antibodies Absent | Glucocorticoid therapy | Therapeutic radiology procedure Local | Splenectomy
Item
4. not previously treated with cytotoxic drugs or antibodies but may have received glucocorticoid monotherapy, local radiation, or splenectomy.
boolean
C0304497 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0003241 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0744425 (UMLS CUI [3])
C1522449 (UMLS CUI [4,1])
C0205276 (UMLS CUI [4,2])
C0037995 (UMLS CUI [5])
Patients Medically unfit | Cyclophosphamide/fludarabine/rituximab Dose Full
Item
5. unfit for full dose fcr chemotherapy.
boolean
C0030705 (UMLS CUI [1,1])
C3841806 (UMLS CUI [1,2])
C1327865 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0443225 (UMLS CUI [2,3])
Platelet Count measurement | Neutrophil count
Item
6. platelets >50x10**9/l. neutrophils>.75x10**9/l.
boolean
C0032181 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
Size of lymph node CT scan | Splenomegaly CT scan
Item
7. at least 1 lymph node >1.5 cm or splenomegaly as detected by ct scan.
boolean
C1285847 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C0038002 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Patients Fit | Cyclophosphamide/fludarabine/rituximab Dose Full
Item
1. fit for full-dose fcr as initial treatment.
boolean
C0030705 (UMLS CUI [1,1])
C0424576 (UMLS CUI [1,2])
C1327865 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0443225 (UMLS CUI [2,3])
Leukoencephalopathy, Progressive Multifocal
Item
2. progressive multifocal leukoencephalopathy (pml).
boolean
C0023524 (UMLS CUI [1])
Bacterial Infection Treatment required for | Mycoses Treatment required for | Parasitic infection Treatment required for | Virus Disease Treatment required for
Item
3. clinically significant bacterial, fungal, parasitic or viral infection, which require therapy.
boolean
C0004623 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0026946 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
C0747256 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])
C0042769 (UMLS CUI [4,1])
C0332121 (UMLS CUI [4,2])
Richter's syndrome | Prolymphocytic Leukemia
Item
4. richter's transformation or prolymphocytic leukemia.
boolean
C0349631 (UMLS CUI [1])
C0023486 (UMLS CUI [2])
Autoimmune hemolytic anemia Uncontrolled | Idiopathic thrombocytopenia purpura Uncontrolled
Item
5. uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura.
boolean
C0002880 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0398650 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Chemotherapy Chronic Lymphocytic Leukemia | Exception Glucocorticoids | Exception Therapeutic radiology procedure Local | Exception Splenectomy
Item
6. prior exposure to chemotherapy for cll with the exception of glucocorticoids, local radiation, or splenectomy.
boolean
C0392920 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0017710 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
C0205276 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0037995 (UMLS CUI [4,2])
Malignant Neoplasms | Exception Curative treatment Malignant Neoplasms | Exception Disease Free Duration | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
7. history of prior malignancy, with the exception of the following: i. malignancy treated with curative intent and with no evidence of active disease for more than 2 years. ii. adequately treated skin cancer. iii. adequately treated cervical carcinoma in situ.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
C0449238 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0699893 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
Cardiovascular Disease
Item
8. currently active clinically significant cardiovascular disease.
boolean
C0007222 (UMLS CUI [1])
Cerebrovascular accident | Intracranial Hemorrhages
Item
9. history of stroke or intracranial hemorrhage within 6 months prior to enrollment.
boolean
C0038454 (UMLS CUI [1])
C0151699 (UMLS CUI [2])
Kidney Failure Requirement Dialysis | Renal Insufficiency Moderate | Renal Insufficiency Severe | Platelet Count measurement
Item
10. renal failure requiring dialysis and patients with moderate and severe renal impairment with platelet counts less than 100,000/ml.
boolean
C0035078 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0011946 (UMLS CUI [1,3])
C1565489 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C1565489 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0032181 (UMLS CUI [4])
Hepatic impairment
Item
11. hepatic impairment.
boolean
C0948807 (UMLS CUI [1])
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