ID

22893

Description

Combination Chemotherapy and Alemtuzumab in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00262925

Link

https://clinicaltrials.gov/show/NCT00262925

Keywords

  1. 6/14/17 6/14/17 -
Uploaded on

June 14, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Recurrent Adult Acute Lymphoblastic Leukemia NCT00262925

Eligibility Recurrent Adult Acute Lymphoblastic Leukemia NCT00262925

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
refractory or relapsed acute lymphoblastic leukemia
Description

Acute lymphocytic leukaemia refractory | Recurrent adult acute lymphoblastic leukemia

Data type

boolean

Alias
UMLS CUI [1]
C4049242
UMLS CUI [2]
C0278785
must be in first relapse or have failed to achieve complete remission with 1 prior regimen
Description

First Relapse | Therapeutic procedure Quantity Complete remission failed

Data type

boolean

Alias
UMLS CUI [1]
C4054953
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0677874
UMLS CUI [2,4]
C0231175
prior central nervous system (cns) leukemia allowed provided cerebrospinal fluid is normal
Description

Central nervous system leukaemia | Normal cerebrospinal fluid

Data type

boolean

Alias
UMLS CUI [1]
C1332884
UMLS CUI [2]
C1852477
ecog performance status of 0-3
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
bilirubin normal
Description

Bilirubin normal

Data type

boolean

Alias
UMLS CUI [1]
C0858307
creatinine normal
Description

Creatinine normal

Data type

boolean

Alias
UMLS CUI [1]
C0860945
human immunodeficiency virus (hiv) negative
Description

HIV negative

Data type

boolean

Alias
UMLS CUI [1]
C0481430
negative pregnancy test
Description

Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0427780
fertile patients must use effective contraception
Description

Fertility Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
hepatitis b positivity
Description

Hepatitis B positive

Data type

boolean

Alias
UMLS CUI [1]
C0856706
bacterial or fungal infection
Description

Bacterial Infections | Mycoses

Data type

boolean

Alias
UMLS CUI [1]
C0004623
UMLS CUI [2]
C0026946
infection requiring treatment with antibiotics
Description

Communicable Disease Requirement Antibiotics

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003232
active cytomegalovirus infection by molecular detection methods
Description

Cytomegalovirus Infection Detection method Molecular

Data type

boolean

Alias
UMLS CUI [1,1]
C0010823
UMLS CUI [1,2]
C0449335
UMLS CUI [1,3]
C1521991
known hypersensitivity to alemtuzumab or its components
Description

Hypersensitivity Alemtuzumab | Hypersensitivity Alemtuzumab Component

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0383429
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0383429
UMLS CUI [2,3]
C1705248
pregnant or nursing
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
other malignancy within the past 5 years except adequately treated basal cell skin cancer or cervical carcinoma
Description

Malignant Neoplasms | Basal cell carcinoma Treated | Cervix carcinoma Treated

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C0302592
UMLS CUI [3,2]
C1522326

Similar models

Eligibility Recurrent Adult Acute Lymphoblastic Leukemia NCT00262925

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Acute lymphocytic leukaemia refractory | Recurrent adult acute lymphoblastic leukemia
Item
refractory or relapsed acute lymphoblastic leukemia
boolean
C4049242 (UMLS CUI [1])
C0278785 (UMLS CUI [2])
First Relapse | Therapeutic procedure Quantity Complete remission failed
Item
must be in first relapse or have failed to achieve complete remission with 1 prior regimen
boolean
C4054953 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0677874 (UMLS CUI [2,3])
C0231175 (UMLS CUI [2,4])
Central nervous system leukaemia | Normal cerebrospinal fluid
Item
prior central nervous system (cns) leukemia allowed provided cerebrospinal fluid is normal
boolean
C1332884 (UMLS CUI [1])
C1852477 (UMLS CUI [2])
ECOG performance status
Item
ecog performance status of 0-3
boolean
C1520224 (UMLS CUI [1])
Bilirubin normal
Item
bilirubin normal
boolean
C0858307 (UMLS CUI [1])
Creatinine normal
Item
creatinine normal
boolean
C0860945 (UMLS CUI [1])
HIV negative
Item
human immunodeficiency virus (hiv) negative
boolean
C0481430 (UMLS CUI [1])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Hepatitis B positive
Item
hepatitis b positivity
boolean
C0856706 (UMLS CUI [1])
Bacterial Infections | Mycoses
Item
bacterial or fungal infection
boolean
C0004623 (UMLS CUI [1])
C0026946 (UMLS CUI [2])
Communicable Disease Requirement Antibiotics
Item
infection requiring treatment with antibiotics
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
Cytomegalovirus Infection Detection method Molecular
Item
active cytomegalovirus infection by molecular detection methods
boolean
C0010823 (UMLS CUI [1,1])
C0449335 (UMLS CUI [1,2])
C1521991 (UMLS CUI [1,3])
Hypersensitivity Alemtuzumab | Hypersensitivity Alemtuzumab Component
Item
known hypersensitivity to alemtuzumab or its components
boolean
C0020517 (UMLS CUI [1,1])
C0383429 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0383429 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Malignant Neoplasms | Basal cell carcinoma Treated | Cervix carcinoma Treated
Item
other malignancy within the past 5 years except adequately treated basal cell skin cancer or cervical carcinoma
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0302592 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])

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