ID

26001

Beschrijving

Safety and Dose Ranging Study of ALXN6000 to Treat Relapsing or Refractory CLL or MM; ODM derived from: https://clinicaltrials.gov/show/NCT00648739

Link

https://clinicaltrials.gov/show/NCT00648739

Trefwoorden

Versies (1)
  1. 04-10-17 04-10-17 -
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See clinicaltrials.gov

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4 oktober 2017

DOI

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Creative Commons BY 4.0
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Eligibility B-cell Chronic Lymphocytic Leukemia NCT00648739

Engels

Eligibility B-cell Chronic Lymphocytic Leukemia NCT00648739

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
relapsing or refractory b cll or mm
Beschrijving

Recurrent Chronic Lymphoid Leukemia | Chronic lymphocytic leukaemia refractory | Recurrent multiple myeloma | Refractory multiple myeloma

Datatype

boolean

Alias
UMLS CUI [1]
C0854802
UMLS CUI [2]
C0278791
UMLS CUI [3]
C1370446
UMLS CUI [4]
C0278620
ecog performance status 0-2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
anticipated survival of greater than 6 months.
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
female patients of childbearing potential must agree to use two forms of contraception
Beschrijving

Childbearing Potential Contraceptive methods Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
patients must have a standard indication for treatment of their malignancy
Beschrijving

Standard Indication Cancer treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C1442989
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C0920425
is willing and able to give written informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
absolute neutrophil count (anc) < 1000 x 109/l
Beschrijving

Absolute neutrophil count

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
platelet count < 50,000 x 109/l
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
pregnant or lactating women.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
prior history of autoimmune hemolysis requiring therapy.
Beschrijving

Hemolysis Autoimmune Treatment required for

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019054
UMLS CUI [1,2]
C0443146
UMLS CUI [1,3]
C0332121
prior history of immune thrombocytopenia.
Beschrijving

Autoimmune thrombocytopenia

Datatype

boolean

Alias
UMLS CUI [1]
C0242584
active autoimmune disease requiring immunosuppressive therapy.
Beschrijving

Autoimmune Disease Requirement Therapeutic immunosuppression

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0021079
positive coombs' test (neither direct or indirect)
Beschrijving

Direct Coombs test positive | Indirect Coombs test positive

Datatype

boolean

Alias
UMLS CUI [1]
C0151569
UMLS CUI [2]
C0151570
ongoing corticosteroid treatment equivalent to the mineralocortacoid potency of 10 milligram (mg) /day of prednisone, or greater, for any condition.
Beschrijving

Adrenal Cortex Hormones | Equivalent Mineralocorticoid Effect Prednisone U/day

Datatype

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2,1]
C0205163
UMLS CUI [2,2]
C3179191
UMLS CUI [2,3]
C0032952
UMLS CUI [2,4]
C0456683
prior stem cell transplantation within 4 weeks prior to enrollment.
Beschrijving

Stem cell transplantation

Datatype

boolean

Alias
UMLS CUI [1]
C1504389
prior chemotherapy for the applicable malignancy within 30 days of enrollment.
Beschrijving

Chemotherapy Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0006826
neurosurgery or cranial radiation therapy within one year of enrollment.
Beschrijving

Neurosurgical Procedures | Therapeutic radiology procedure cranial

Datatype

boolean

Alias
UMLS CUI [1]
C0524850
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0037303
clinically significant renal, hepatic or heart disease.
Beschrijving

Kidney Disease | Liver disease | Heart Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0018799
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Similar models

Eligibility B-cell Chronic Lymphocytic Leukemia NCT00648739

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Recurrent Chronic Lymphoid Leukemia | Chronic lymphocytic leukaemia refractory | Recurrent multiple myeloma | Refractory multiple myeloma
Item
relapsing or refractory b cll or mm
boolean
C0854802 (UMLS CUI [1])
C0278791 (UMLS CUI [2])
C1370446 (UMLS CUI [3])
C0278620 (UMLS CUI [4])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
anticipated survival of greater than 6 months.
boolean
C0023671 (UMLS CUI [1])
Childbearing Potential Contraceptive methods Quantity
Item
female patients of childbearing potential must agree to use two forms of contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Standard Indication Cancer treatment
Item
patients must have a standard indication for treatment of their malignancy
boolean
C1442989 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,3])
Informed Consent
Item
is willing and able to give written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Absolute neutrophil count
Item
absolute neutrophil count (anc) < 1000 x 109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count < 50,000 x 109/l
boolean
C0032181 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hemolysis Autoimmune Treatment required for
Item
prior history of autoimmune hemolysis requiring therapy.
boolean
C0019054 (UMLS CUI [1,1])
C0443146 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,3])
Autoimmune thrombocytopenia
Item
prior history of immune thrombocytopenia.
boolean
C0242584 (UMLS CUI [1])
Autoimmune Disease Requirement Therapeutic immunosuppression
Item
active autoimmune disease requiring immunosuppressive therapy.
boolean
C0004364 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0021079 (UMLS CUI [1,3])
Direct Coombs test positive | Indirect Coombs test positive
Item
positive coombs' test (neither direct or indirect)
boolean
C0151569 (UMLS CUI [1])
C0151570 (UMLS CUI [2])
Adrenal Cortex Hormones | Equivalent Mineralocorticoid Effect Prednisone U/day
Item
ongoing corticosteroid treatment equivalent to the mineralocortacoid potency of 10 milligram (mg) /day of prednisone, or greater, for any condition.
boolean
C0001617 (UMLS CUI [1])
C0205163 (UMLS CUI [2,1])
C3179191 (UMLS CUI [2,2])
C0032952 (UMLS CUI [2,3])
C0456683 (UMLS CUI [2,4])
Stem cell transplantation
Item
prior stem cell transplantation within 4 weeks prior to enrollment.
boolean
C1504389 (UMLS CUI [1])
Chemotherapy Malignant Neoplasms
Item
prior chemotherapy for the applicable malignancy within 30 days of enrollment.
boolean
C0392920 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
Neurosurgical Procedures | Therapeutic radiology procedure cranial
Item
neurosurgery or cranial radiation therapy within one year of enrollment.
boolean
C0524850 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0037303 (UMLS CUI [2,2])
Kidney Disease | Liver disease | Heart Disease
Item
clinically significant renal, hepatic or heart disease.
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0018799 (UMLS CUI [3])
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