ID

25934

Description

Calaspargase Pegol or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00671034

Link

https://clinicaltrials.gov/show/NCT00671034

Keywords

Versions (1)
  1. 9/27/17 9/27/17 -
Uploaded on

September 27, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility B-cell Adult Acute Lymphoblastic Leukemia NCT00671034

English

Eligibility B-cell Adult Acute Lymphoblastic Leukemia NCT00671034

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must be eligible for and enrolled on aall08b1 or the successor classification study
Description

Study Subject Participation Status | Classification Study

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008902
UMLS CUI [2,2]
C2603343
patients must have newly diagnosed high-risk b lymphoblastic leukemia (world health organization [who] 2008 classification) (also termed b-precursor acute lymphoblastic leukemia)
Description

Precursor B-cell lymphoblastic leukemia High risk | Precursor B-lymphoblastic leukaemia acute

Data type

boolean

Alias
UMLS CUI [1,1]
C1292769
UMLS CUI [1,2]
C0332167
UMLS CUI [2]
C1737235
white blood cell (wbc) >= 50,000/μl for patients age 1-9 or any wbc count for patients age 10-30 or for patients treated with prior steroids
Description

White Blood Cell Count procedure | Age | Steroid therapy

Data type

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0149783
patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine; 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; (note: 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

Cytotoxic Chemotherapy Absent | Exception Steroids | Exception Cytarabine Intrathecal | Diagnostic procedures on bone marrow | Venous line insertion | Lumbar Puncture second Preventing | CNS status Determination | Systemic Chemotherapy | Intrathecal chemotherapy

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
UMLS CUI [4]
C0176713
UMLS CUI [5]
C0398266
UMLS CUI [6,1]
C0037943
UMLS CUI [6,2]
C0205436
UMLS CUI [6,3]
C1292733
UMLS CUI [7,1]
C0449389
UMLS CUI [7,2]
C1148554
UMLS CUI [8]
C1883256
UMLS CUI [9]
C1517560
patients receiving prior steroid therapy are eligible for this study; the dose and duration of previous steroid therapy should be carefully documented
Description

Steroid therapy Dosage | Steroid therapy Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C0149783
UMLS CUI [2,2]
C0449238
pregnancy tests with a negative result must be obtained in all post-menarchal females
Description

Menarche Status post Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0025274
UMLS CUI [1,2]
C0231290
UMLS CUI [1,3]
C0427780
lactating females must agree that they will not breastfeed a child while on this study
Description

Breast Feeding Absent During Participation Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0006147
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0679823
UMLS CUI [1,5]
C0008976
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with down syndrome are excluded from this study
Description

Down Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0013080
patients with testicular leukemia at diagnosis are excluded from this study
Description

testicular leukemia

Data type

boolean

Alias
UMLS CUI [1]
C1336711
pregnant female patients are excluded from this study
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility B-cell Adult Acute Lymphoblastic Leukemia NCT00671034

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject Participation Status | Classification Study
Item
patients must be eligible for and enrolled on aall08b1 or the successor classification study
boolean
C2348568 (UMLS CUI [1])
C0008902 (UMLS CUI [2,1])
C2603343 (UMLS CUI [2,2])
Precursor B-cell lymphoblastic leukemia High risk | Precursor B-lymphoblastic leukaemia acute
Item
patients must have newly diagnosed high-risk b lymphoblastic leukemia (world health organization [who] 2008 classification) (also termed b-precursor acute lymphoblastic leukemia)
boolean
C1292769 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C1737235 (UMLS CUI [2])
White Blood Cell Count procedure | Age | Steroid therapy
Item
white blood cell (wbc) >= 50,000/μl for patients age 1-9 or any wbc count for patients age 10-30 or for patients treated with prior steroids
boolean
C0023508 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0149783 (UMLS CUI [3])
Cytotoxic Chemotherapy Absent | Exception Steroids | Exception Cytarabine Intrathecal | Diagnostic procedures on bone marrow | Venous line insertion | Lumbar Puncture second Preventing | CNS status Determination | Systemic Chemotherapy | Intrathecal chemotherapy
Item
patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine; 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; (note: 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
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])
C0176713 (UMLS CUI [4])
C0398266 (UMLS CUI [5])
C0037943 (UMLS CUI [6,1])
C0205436 (UMLS CUI [6,2])
C1292733 (UMLS CUI [6,3])
C0449389 (UMLS CUI [7,1])
C1148554 (UMLS CUI [7,2])
C1883256 (UMLS CUI [8])
C1517560 (UMLS CUI [9])
Steroid therapy Dosage | Steroid therapy Duration
Item
patients receiving prior steroid therapy are eligible for this study; the dose and duration of previous steroid therapy should be carefully documented
boolean
C0149783 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0149783 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Menarche Status post Pregnancy test negative
Item
pregnancy tests with a negative result must be obtained in all post-menarchal females
boolean
C0025274 (UMLS CUI [1,1])
C0231290 (UMLS CUI [1,2])
C0427780 (UMLS CUI [1,3])
Breast Feeding Absent During Participation Clinical Trial
Item
lactating females must agree that they will not breastfeed a child while on this study
boolean
C0006147 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0679823 (UMLS CUI [1,4])
C0008976 (UMLS CUI [1,5])
Item Group
C0680251 (UMLS CUI)
Down Syndrome
Item
patients with down syndrome are excluded from this study
boolean
C0013080 (UMLS CUI [1])
testicular leukemia
Item
patients with testicular leukemia at diagnosis are excluded from this study
boolean
C1336711 (UMLS CUI [1])
Pregnancy
Item
pregnant female patients are excluded from this study
boolean
C0032961 (UMLS CUI [1])
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