ID

30179

Beskrivning

8-Chloro-Adenosine in Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00714103

Länk

https://clinicaltrials.gov/show/NCT00714103

Nyckelord

Versioner (1)
  1. 2018-05-17 2018-05-17 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

17 maj 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Leukemia NCT00714103

Engelsk

Eligibility Leukemia NCT00714103

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00714103
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must have a diagnosis of chronic lymphocytic leukemia and must be previously treated with at least one prior treatment regimen, including a purine-analogue based treatment.
Beskrivning

Prior Therapy Quantity Chronic Lymphocytic Leukemia | Therapeutic procedure Based Purine analog

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0023434
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1705938
UMLS CUI [2,3]
C1268902
2. patients must be rai stage iii or iv or rai stage 0-ii and have one or more criteria for active disease as defined by the nci-working group as: a) weight loss of more than 10% in the last 6 months; b) fatigue; c) fever or night sweats without evidence of infection; d) progressive anemia or thrombocytopenia; e) progressive lymphocytosis with a lymphocyte doubling time </= 6 months; or f) marked hypogammaglobulinemia or paraproteinemia.
Beskrivning

Rai Staging System | Weight decreased Percentage Timespan | Fatigue | Fever | Night sweats | Communicable Disease Absent | Progressive anemia | Thrombocytopenia Progressive | Lymphocytosis Progressive | Lymphocyte Doubling Time

Datatyp

boolean

Alias
UMLS CUI [1]
C1514715
UMLS CUI [2,1]
C1262477
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0872291
UMLS CUI [3]
C0015672
UMLS CUI [4]
C0015967
UMLS CUI [5]
C0028081
UMLS CUI [6,1]
C0009450
UMLS CUI [6,2]
C0332197
UMLS CUI [7]
C0865245
UMLS CUI [8,1]
C0040034
UMLS CUI [8,2]
C0205329
UMLS CUI [9,1]
C0024282
UMLS CUI [9,2]
C0205329
UMLS CUI [10,1]
C0024264
UMLS CUI [10,2]
C2986483
3. all patients must have a zubrod performance status of </= 2.
Beskrivning

Zubrod Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C3714786
4. all patients must be age >/= 18 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
5. patients may not receive concurrent treatment for their cll and must have been off treatment (chemotherapy, immunotherapy, or radiotherapy) for 4 weeks prior to treatment on this study and recovered from toxic effects of that therapy.
Beskrivning

Absence Therapeutic procedure Chronic Lymphocytic Leukemia | Chemotherapy Absent | Immunotherapy Absent | Therapeutic radiology procedure Absent | Toxic effect Patient recovered

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0023434
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0021083
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0600688
UMLS CUI [5,2]
C1115804
6. all patients must have adequate renal function indicated by serum creatinine </=2.5x upper limits of normal (uln) and adequate liver function indicated by alt or ast </= 2.5x uln and total bilirubin </= 2.5x uln.
Beskrivning

Renal function | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
7. all patients must have a pre-treatment platelet count of >/= 50,000 /µl and not require transfusion to maintain this platelet count unless thrombocytopenia is due to marrow infiltrated with disease.
Beskrivning

Platelet Count measurement pre treatment | Absence Requirement Transfusion | Exception Thrombocytopenia | Etiology Marrow Infiltration Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032181
UMLS CUI [1,2]
C2709094
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C1879316
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0040034
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0376152
UMLS CUI [4,3]
C0332448
UMLS CUI [4,4]
C0012634
8. all patients or appropriate surrogate must provide informed consent.
Beskrivning

Informed Consent | Informed Consent Patient Representatives

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with active uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia purpura.
Beskrivning

Autoimmune hemolytic anemia Uncontrolled | Immune thrombocytopenic purpura Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002880
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0398650
UMLS CUI [2,2]
C0205318
2. patients with active uncontrolled fungal, bacterial, or viral infection.
Beskrivning

Mycoses Uncontrolled | Bacterial Infection Uncontrolled | Virus Disease Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026946
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0004623
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0042769
UMLS CUI [3,2]
C0205318
3. patients who are pregnant or breast-feeding.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Leukemia NCT00714103

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00714103
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Prior Therapy Quantity Chronic Lymphocytic Leukemia | Therapeutic procedure Based Purine analog
Item
1. patients must have a diagnosis of chronic lymphocytic leukemia and must be previously treated with at least one prior treatment regimen, including a purine-analogue based treatment.
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0023434 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C1705938 (UMLS CUI [2,2])
C1268902 (UMLS CUI [2,3])
Rai Staging System | Weight decreased Percentage Timespan | Fatigue | Fever | Night sweats | Communicable Disease Absent | Progressive anemia | Thrombocytopenia Progressive | Lymphocytosis Progressive | Lymphocyte Doubling Time
Item
2. patients must be rai stage iii or iv or rai stage 0-ii and have one or more criteria for active disease as defined by the nci-working group as: a) weight loss of more than 10% in the last 6 months; b) fatigue; c) fever or night sweats without evidence of infection; d) progressive anemia or thrombocytopenia; e) progressive lymphocytosis with a lymphocyte doubling time </= 6 months; or f) marked hypogammaglobulinemia or paraproteinemia.
boolean
C1514715 (UMLS CUI [1])
C1262477 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0872291 (UMLS CUI [2,3])
C0015672 (UMLS CUI [3])
C0015967 (UMLS CUI [4])
C0028081 (UMLS CUI [5])
C0009450 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0865245 (UMLS CUI [7])
C0040034 (UMLS CUI [8,1])
C0205329 (UMLS CUI [8,2])
C0024282 (UMLS CUI [9,1])
C0205329 (UMLS CUI [9,2])
C0024264 (UMLS CUI [10,1])
C2986483 (UMLS CUI [10,2])
Zubrod Performance Status
Item
3. all patients must have a zubrod performance status of </= 2.
boolean
C3714786 (UMLS CUI [1])
Age
Item
4. all patients must be age >/= 18 years.
boolean
C0001779 (UMLS CUI [1])
Absence Therapeutic procedure Chronic Lymphocytic Leukemia | Chemotherapy Absent | Immunotherapy Absent | Therapeutic radiology procedure Absent | Toxic effect Patient recovered
Item
5. patients may not receive concurrent treatment for their cll and must have been off treatment (chemotherapy, immunotherapy, or radiotherapy) for 4 weeks prior to treatment on this study and recovered from toxic effects of that therapy.
boolean
C0332197 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0023434 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0021083 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0600688 (UMLS CUI [5,1])
C1115804 (UMLS CUI [5,2])
Renal function | Creatinine measurement, serum
Item
6. all patients must have adequate renal function indicated by serum creatinine </=2.5x upper limits of normal (uln) and adequate liver function indicated by alt or ast </= 2.5x uln and total bilirubin </= 2.5x uln.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Platelet Count measurement pre treatment | Absence Requirement Transfusion | Exception Thrombocytopenia | Etiology Marrow Infiltration Disease
Item
7. all patients must have a pre-treatment platelet count of >/= 50,000 /µl and not require transfusion to maintain this platelet count unless thrombocytopenia is due to marrow infiltrated with disease.
boolean
C0032181 (UMLS CUI [1,1])
C2709094 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C1879316 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0040034 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0376152 (UMLS CUI [4,2])
C0332448 (UMLS CUI [4,3])
C0012634 (UMLS CUI [4,4])
Informed Consent | Informed Consent Patient Representatives
Item
8. all patients or appropriate surrogate must provide informed consent.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Autoimmune hemolytic anemia Uncontrolled | Immune thrombocytopenic purpura Uncontrolled
Item
1. patients with active uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia purpura.
boolean
C0002880 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0398650 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Mycoses Uncontrolled | Bacterial Infection Uncontrolled | Virus Disease Uncontrolled
Item
2. patients with active uncontrolled fungal, bacterial, or viral infection.
boolean
C0026946 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0004623 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0042769 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
3. patients who are pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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