ID

14317

Description

Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00003700

Link

https://clinicaltrials.gov/show/NCT00003700

Keywords

  1. 4/10/16 4/10/16 -
Uploaded on

April 10, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Leukemia NCT00003700

Eligibility Leukemia NCT00003700

  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00003700
Criteria
Description

Criteria

2. uncontrolled or severe cardiovascular disease.
Description

Cardiovascular disease

Data type

boolean

Alias
UMLS CUI [1]
C0007222
3. history of pancreatitis or overt coagulopathy (prior cerebrovascular accident or hemorrhage, transient ischemic attack or deep venous thrombosis).
Description

Pancreatitis or coagulopathy

Data type

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0005779
4. elevations in bilirubin, creatinine, or amylase that may suggest impaired hepatic, renal, or pancreatic function must be considered as potentially serious obstacles for safe tolerance of the therapy prescribed in this protocol.
Description

Bilirubin, creatinine, or amylase measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0201883
5. prior use of the agents administered in this protocol for other non-malignant disease may reduce the likelihood of beneficial outcome, and should also be considered prior to enrolling patients.
Description

Study agents

Data type

boolean

Alias
UMLS CUI [1]
C1521826
6. treatment under this protocol would expose an unborn child to significant risks.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
women and men of reproductive potential should agree to use an effective means of birth control.
Description

Contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
7. unequivocal histologic diagnosis of acute lymphoblastic leukemia (all), fab l1-or l2 or acute undifferentiated leukemia (aul).
Description

All, fab l1-or l2 or aul

Data type

boolean

Alias
UMLS CUI [1]
C0023449
UMLS CUI [2]
C0457324
UMLS CUI [3]
C0457325
UMLS CUI [4]
C0280141
8. age ≥ 15 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
9. prior treatment: no prior treatment for leukemia, with three permissible exceptions:
Description

Prior treatment

Data type

boolean

Alias
UMLS CUI [1]
C1514463
i. emergency leukapheresis; ii. emergency treatment for hyperleukocytosis with hydroxyurea; iii. cranial rt for cns leukostasis (one dose only).
Description

Leukapheresis, hydroxyurea treatment or radiotherapy to head

Data type

boolean

Alias
UMLS CUI [1]
C0023416
UMLS CUI [2]
C0020402
UMLS CUI [3]
C1997353

Similar models

Eligibility Leukemia NCT00003700

  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00003700
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Cardiovascular disease
Item
2. uncontrolled or severe cardiovascular disease.
boolean
C0007222 (UMLS CUI [1])
Pancreatitis or coagulopathy
Item
3. history of pancreatitis or overt coagulopathy (prior cerebrovascular accident or hemorrhage, transient ischemic attack or deep venous thrombosis).
boolean
C0030305 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
Bilirubin, creatinine, or amylase measurement
Item
4. elevations in bilirubin, creatinine, or amylase that may suggest impaired hepatic, renal, or pancreatic function must be considered as potentially serious obstacles for safe tolerance of the therapy prescribed in this protocol.
boolean
C1278039 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0201883 (UMLS CUI [3])
Study agents
Item
5. prior use of the agents administered in this protocol for other non-malignant disease may reduce the likelihood of beneficial outcome, and should also be considered prior to enrolling patients.
boolean
C1521826 (UMLS CUI [1])
Pregnancy
Item
6. treatment under this protocol would expose an unborn child to significant risks.
boolean
C0032961 (UMLS CUI [1])
Contraception
Item
women and men of reproductive potential should agree to use an effective means of birth control.
boolean
C0700589 (UMLS CUI [1])
All, fab l1-or l2 or aul
Item
7. unequivocal histologic diagnosis of acute lymphoblastic leukemia (all), fab l1-or l2 or acute undifferentiated leukemia (aul).
boolean
C0023449 (UMLS CUI [1])
C0457324 (UMLS CUI [2])
C0457325 (UMLS CUI [3])
C0280141 (UMLS CUI [4])
Age
Item
8. age ≥ 15 years
boolean
C0001779 (UMLS CUI [1])
Prior treatment
Item
9. prior treatment: no prior treatment for leukemia, with three permissible exceptions:
boolean
C1514463 (UMLS CUI [1])
Leukapheresis, hydroxyurea treatment or radiotherapy to head
Item
i. emergency leukapheresis; ii. emergency treatment for hyperleukocytosis with hydroxyurea; iii. cranial rt for cns leukostasis (one dose only).
boolean
C0023416 (UMLS CUI [1])
C0020402 (UMLS CUI [2])
C1997353 (UMLS CUI [3])

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