ID

37696

Beschreibung

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

Stichworte

Versionen (1)
  1. 18.08.19 18.08.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

18. August 2019

DOI

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

Englisch

Eligibility B-cell Adult Acute Lymphoblastic Leukemia NCT00866307

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Eligibility Clinical Trial Specified | Enrollment Clinical Trial Specified

Datentyp

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)
Beschreibung

High risk of Precursor B-cell lymphoblastic leukemia

Datentyp

boolean

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

White Blood Cell Count criteria

Datentyp

boolean

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

Age | White Blood Cell Count procedure

Datentyp

boolean

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

Age | White Blood Cell Count Any

Datentyp

boolean

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

Steroid therapy | White Blood Cell Count Any

Datentyp

boolean

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

Testicular leukemia | White Blood Cell Count Any

Datentyp

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
Beschreibung

Cytotoxic Chemotherapy Absent | Exception Steroids | Exception Cytarabine Intrathecal

Datentyp

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
Beschreibung

Cytarabine Intrathecal | CNS Status Determined by Sample

Datentyp

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
Beschreibung

Steroid therapy Dose Duration

Datentyp

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
Beschreibung

Informed Consent | Informed Consent Parent | Informed Consent Guardian

Datentyp

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
Beschreibung

Human study Requirement Fulfill

Datentyp

boolean

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

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
Beschreibung

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

Datentyp

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
Beschreibung

Down Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0013080
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Ähnliche Modelle

Eligibility B-cell Adult Acute Lymphoblastic Leukemia NCT00866307

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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