ID

37696

Description

Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011); ODM derived from: https://clinicaltrials.gov/show/NCT00866307

Link

https://clinicaltrials.gov/show/NCT00866307

Keywords

Versions (1)
  1. 8/18/19 8/18/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 18, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility B-cell Adult Acute Lymphoblastic Leukemia NCT00866307

English

Eligibility B-cell Adult Acute Lymphoblastic Leukemia NCT00866307

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must be eligible for and enrolled on aall03b1 or the successor classification study
Description

Eligibility Clinical Trial Specified | Enrollment Clinical Trial Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205369
UMLS CUI [2,1]
C1516879
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0205369
patients must have newly diagnosed high-risk b-precursor acute lymphoblastic leukemia (all)
Description

High risk of Precursor B-cell lymphoblastic leukemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C1292769
wbc criteria
Description

White Blood Cell Count criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C0243161
age 1.00-9.99 years: wbc >= 50,000/ul
Description

Age | White Blood Cell Count procedure

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0023508
age 10.00 - 30.99 years: any wbc
Description

Age | White Blood Cell Count Any

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0023508
UMLS CUI [2,2]
C1552551
prior steroid therapy: any wbc
Description

Steroid therapy | White Blood Cell Count Any

Data type

boolean

Alias
UMLS CUI [1]
C0149783
UMLS CUI [2,1]
C0023508
UMLS CUI [2,2]
C1552551
patients with testicular leukemia: any wbc
Description

Testicular leukemia | White Blood Cell Count Any

Data type

boolean

Alias
UMLS CUI [1]
C1336711
UMLS CUI [2,1]
C0023508
UMLS CUI [2,2]
C1552551
patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine
Description

Cytotoxic Chemotherapy Absent | Exception Steroids | Exception Cytarabine Intrathecal

Data type

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0038317
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0010711
UMLS CUI [3,3]
C0677897
intrathecal chemotherapy with cytarabine is allowed prior to registration for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; the cns status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment; systemic chemotherapy must begin within 72 hours of this intrathecal therapy
Description

Cytarabine Intrathecal | CNS Status Determined by Sample

Data type

boolean

Alias
UMLS CUI [1,1]
C0010711
UMLS CUI [1,2]
C0677897
UMLS CUI [2,1]
C3714787
UMLS CUI [2,2]
C0449438
UMLS CUI [2,3]
C0521095
UMLS CUI [2,4]
C0370003
patients receiving prior steroid therapy are eligible for study; the dose and duration of previous steroid therapy should be carefully documented
Description

Steroid therapy Dose Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0449238
all patients and/or their parents or legal guardians must sign a written informed consent
Description

Informed Consent | Informed Consent Parent | Informed Consent Guardian

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030551
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1274041
all institutional, food and drug administration (fda), and national cancer institute (nci) requirements for human studies must be met
Description

Human study Requirement Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0178693
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1550543
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant female patients are ineligible; pregnancy tests with a negative result must be obtained in all post-menarchal females; males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method; lactating females must agree that they will not breastfeed a child while on this study
Description

Pregnancy | Gender Post Menarche Pregnancy test negative | Females & males of reproductive potential Contraceptive methods | Breast Feeding Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0025274
UMLS CUI [2,4]
C0427780
UMLS CUI [3,1]
C4034483
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C0006147
UMLS CUI [4,2]
C0332197
patients with down syndrome (ds) are ineligible since excessive toxicities and death have been noted for those enrolled on aall0232 receiving the prednisone/capizzi methotrexate (pc) arm of treatment, which is the backbone regimen for the current study
Description

Down Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0013080
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Similar models

Eligibility B-cell Adult Acute Lymphoblastic Leukemia NCT00866307

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Eligibility Clinical Trial Specified | Enrollment Clinical Trial Specified
Item
patients must be eligible for and enrolled on aall03b1 or the successor classification study
boolean
C1548635 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C1516879 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
High risk of Precursor B-cell lymphoblastic leukemia
Item
patients must have newly diagnosed high-risk b-precursor acute lymphoblastic leukemia (all)
boolean
C0332167 (UMLS CUI [1,1])
C1292769 (UMLS CUI [1,2])
White Blood Cell Count criteria
Item
wbc criteria
boolean
C0023508 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Age | White Blood Cell Count procedure
Item
age 1.00-9.99 years: wbc >= 50,000/ul
boolean
C0001779 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
Age | White Blood Cell Count Any
Item
age 10.00 - 30.99 years: any wbc
boolean
C0001779 (UMLS CUI [1])
C0023508 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
Steroid therapy | White Blood Cell Count Any
Item
prior steroid therapy: any wbc
boolean
C0149783 (UMLS CUI [1])
C0023508 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
Testicular leukemia | White Blood Cell Count Any
Item
patients with testicular leukemia: any wbc
boolean
C1336711 (UMLS CUI [1])
C0023508 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
Cytotoxic Chemotherapy Absent | Exception Steroids | Exception Cytarabine Intrathecal
Item
patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine
boolean
C0677881 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0038317 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0010711 (UMLS CUI [3,2])
C0677897 (UMLS CUI [3,3])
Cytarabine Intrathecal | CNS Status Determined by Sample
Item
intrathecal chemotherapy with cytarabine is allowed prior to registration for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; the cns status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment; systemic chemotherapy must begin within 72 hours of this intrathecal therapy
boolean
C0010711 (UMLS CUI [1,1])
C0677897 (UMLS CUI [1,2])
C3714787 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
C0521095 (UMLS CUI [2,3])
C0370003 (UMLS CUI [2,4])
Steroid therapy Dose Duration
Item
patients receiving prior steroid therapy are eligible for study; the dose and duration of previous steroid therapy should be carefully documented
boolean
C0149783 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Informed Consent | Informed Consent Parent | Informed Consent Guardian
Item
all patients and/or their parents or legal guardians must sign a written informed consent
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C1274041 (UMLS CUI [3,2])
Human study Requirement Fulfill
Item
all institutional, food and drug administration (fda), and national cancer institute (nci) requirements for human studies must be met
boolean
C0178693 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Gender Post Menarche Pregnancy test negative | Females & males of reproductive potential Contraceptive methods | Breast Feeding Absent
Item
pregnant female patients are ineligible; pregnancy tests with a negative result must be obtained in all post-menarchal females; males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method; lactating females must agree that they will not breastfeed a child while on this study
boolean
C0032961 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0025274 (UMLS CUI [2,3])
C0427780 (UMLS CUI [2,4])
C4034483 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0006147 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Down Syndrome
Item
patients with down syndrome (ds) are ineligible since excessive toxicities and death have been noted for those enrolled on aall0232 receiving the prednisone/capizzi methotrexate (pc) arm of treatment, which is the backbone regimen for the current study
boolean
C0013080 (UMLS CUI [1])
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