ID

28038

Beschrijving

Lenalidomide in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00439231

Link

https://clinicaltrials.gov/show/NCT00439231

Trefwoorden

Versies (2)
  1. 12-12-17 12-12-17 -
  2. 13-12-17 13-12-17 -
Houder van rechten

See clinicaltrials.gov

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12 december 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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Eligibility Chronic Lymphocytic Leukemia (CLL) NCT00439231

Engels

Eligibility Chronic Lymphocytic Leukemia (CLL) NCT00439231

1 Formulieren  
Criteria
Beschrijving

Criteria

1. diagnosed with chronic lymphocytic leukemia (cll) or small lymphocytic leukemia (sll).
Beschrijving

Chronic Lymphocytic Leukemia | Other Coding | Small Lymphocytic Lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2]
C3846158
UMLS CUI [3]
C0855095
2. failed prior standard of care therapy for cll.
Beschrijving

Standard of Care failed Chronic Lymphocytic Leukemia

Datatype

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C0231175
UMLS CUI [1,3]
C0023434
3. neutrophil count (anc) greater than or equal to 500/microliter (mcl).
Beschrijving

Neutrophil count

Datatype

boolean

Alias
UMLS CUI [1]
C0200633
4. platelet count greater than or equal to 20,000/mcl.
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
5. age 21-99.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. chronic or current clinically significant infection, including hiv positivity or uncontrolled infection.
Beschrijving

Chronic infectious disease | Communicable Disease | HIV Seropositivity | Communicable Disease Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1]
C0151317
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0019699
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C0205318
2. eastern cooperative oncology group (ecog) performance greater than 2.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
3. other concurrent anticancer therapies.
Beschrijving

Cancer treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0920425
4. less than 4 weeks from last systemic therapy for cll. steroids up to 2 weeks before the start of treatment are permissible.
Beschrijving

Systemic therapy Chronic Lymphocytic Leukemia | Steroids allowed

Datatype

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0023434
UMLS CUI [2,1]
C0038317
UMLS CUI [2,2]
C0683607
5. moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the patient's ability to tolerate protocol therapy.
Beschrijving

Moribund | Comorbidity Severe | Investigational Therapy Unsuccessful | Liver disease | Kidney Disease | Heart Disease | Nervous system disorder | Lung disease | Communicable Disease | Metabolic Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0424547
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0949266
UMLS CUI [3,2]
C1272705
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0022658
UMLS CUI [6]
C0018799
UMLS CUI [7]
C0027765
UMLS CUI [8]
C0024115
UMLS CUI [9]
C0009450
UMLS CUI [10]
C0025517
6. creatinine greater than 1.5 times the upper limit of normal.
Beschrijving

Serum creatinine raised

Datatype

boolean

Alias
UMLS CUI [1]
C0700225
7. women who are pregnant or nursing, as well as women of childbearing potential who are unwilling to use a dual method of contraception.
Beschrijving

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive method Double Unwilling

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0205173
UMLS CUI [3,4]
C0558080
8. men who are unwilling to use a barrier protection.
Beschrijving

Gender | Barrier Contraception Unwilling

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0004764
UMLS CUI [2,2]
C0558080
9. inability to understand the investigational nature of the study; inability to provide informed consent.
Beschrijving

Study Protocol Comprehension Unable | Informed Consent Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
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Similar models

Eligibility Chronic Lymphocytic Leukemia (CLL) NCT00439231

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Chronic Lymphocytic Leukemia | Other Coding | Small Lymphocytic Lymphoma
Item
1. diagnosed with chronic lymphocytic leukemia (cll) or small lymphocytic leukemia (sll).
boolean
C0023434 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
C0855095 (UMLS CUI [3])
Standard of Care failed Chronic Lymphocytic Leukemia
Item
2. failed prior standard of care therapy for cll.
boolean
C2936643 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0023434 (UMLS CUI [1,3])
Neutrophil count
Item
3. neutrophil count (anc) greater than or equal to 500/microliter (mcl).
boolean
C0200633 (UMLS CUI [1])
Platelet Count measurement
Item
4. platelet count greater than or equal to 20,000/mcl.
boolean
C0032181 (UMLS CUI [1])
Age
Item
5. age 21-99.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chronic infectious disease | Communicable Disease | HIV Seropositivity | Communicable Disease Uncontrolled
Item
1. chronic or current clinically significant infection, including hiv positivity or uncontrolled infection.
boolean
C0151317 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
C0009450 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
ECOG performance status
Item
2. eastern cooperative oncology group (ecog) performance greater than 2.
boolean
C1520224 (UMLS CUI [1])
Cancer treatment
Item
3. other concurrent anticancer therapies.
boolean
C0920425 (UMLS CUI [1])
Systemic therapy Chronic Lymphocytic Leukemia | Steroids allowed
Item
4. less than 4 weeks from last systemic therapy for cll. steroids up to 2 weeks before the start of treatment are permissible.
boolean
C1515119 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
C0038317 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Moribund | Comorbidity Severe | Investigational Therapy Unsuccessful | Liver disease | Kidney Disease | Heart Disease | Nervous system disorder | Lung disease | Communicable Disease | Metabolic Diseases
Item
5. moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the patient's ability to tolerate protocol therapy.
boolean
C0424547 (UMLS CUI [1])
C0009488 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0949266 (UMLS CUI [3,1])
C1272705 (UMLS CUI [3,2])
C0023895 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0018799 (UMLS CUI [6])
C0027765 (UMLS CUI [7])
C0024115 (UMLS CUI [8])
C0009450 (UMLS CUI [9])
C0025517 (UMLS CUI [10])
Serum creatinine raised
Item
6. creatinine greater than 1.5 times the upper limit of normal.
boolean
C0700225 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive method Double Unwilling
Item
7. women who are pregnant or nursing, as well as women of childbearing potential who are unwilling to use a dual method of contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0205173 (UMLS CUI [3,3])
C0558080 (UMLS CUI [3,4])
Gender | Barrier Contraception Unwilling
Item
8. men who are unwilling to use a barrier protection.
boolean
C0079399 (UMLS CUI [1])
C0004764 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Study Protocol Comprehension Unable | Informed Consent Unable
Item
9. inability to understand the investigational nature of the study; inability to provide informed consent.
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
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