ID

13008

Description

506U78 in Treating Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00003545

Link

https://clinicaltrials.gov/show/NCT00003545

Keywords

  1. 1/11/16 1/11/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 11, 2016

DOI

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License

Creative Commons BY-NC 3.0

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Eligibility Leukemia NCT00003545

Eligibility Leukemia NCT00003545

  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00003545
Criteria
Description

Criteria

histologically confirmed diagnosis of t-cell acute lymphoblastic leukemia (all) or lymphoblastic lymphoma (lbl)
Description

histologically confirmed diagnosis of t-cell acute lymphoblastic leukemia (all) or lymphoblastic lymphoma (lbl)

Data type

boolean

Alias
UMLS CUI [1]
C0023449
UMLS CUI [2]
C0278721
leukemia or lymphoma cells should express at least two of the following cell surface antigens: cd1a, cd2, cd3 (surface or cytoplasmic), cd4, cd5, cd7, and cd8
Description

leukemia or lymphoma cells should express at least two of the following cell surface antigens: cd1a, cd2, cd3 (surface or cytoplasmic), cd4, cd5, cd7, and cd8

Data type

boolean

Alias
UMLS CUI [1]
C0003339
leukemia cells should be negative for myeloperoxidase or sudan black b if the only t cell markers present are cd4 and cd7, the leukemic cells should be demonstrated to lack the myeloid markers cd33 and/or cd13
Description

leukemia cells should be negative for myeloperoxidase or sudan black b if the only t cell markers present are cd4 and cd7, the leukemic cells should be demonstrated to lack the myeloid markers cd33 and/or cd13

Data type

boolean

Alias
UMLS CUI [1]
C2698399
UMLS CUI [2]
C0075489
UMLS CUI [3]
C0003339
refractory to at least one induction treatment regimen or in first or later relapse after achieving a complete remission
Description

induction

Data type

boolean

Alias
UMLS CUI [1]
C3179010
no cns leukemia or lymphoma requiring intrathecal or craniospinal radiotherapy
Description

no cns leukemia or lymphoma requiring intrathecal or craniospinal radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1269563
age: 16 and over
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
bilirubin no greater than 2 times upper limit of normal (unless due to leukemia)
Description

bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C1278039
creatinine clearance at least 50 ml/min (unless due to leukemia)
Description

creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C0373595
no neurologic toxicity of grade 3 or greater during prior treatment of all/lbl
Description

neurologic toxicity

Data type

boolean

Alias
UMLS CUI [1]
C0600688
no preexisting neuropathy of grade 2 or greater regardless of causality
Description

neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0442874
no history of seizure disorder
Description

seizure disorder

Data type

boolean

Alias
UMLS CUI [1]
C0036572
not pregnant or nursing
Description

not pregnant or nursing

Data type

boolean

Alias
UMLS CUI [1]
C0032961
fertile patients must use effective contraception
Description

contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
no concurrent erythropoietin
Description

erythropoietin

Data type

boolean

Alias
UMLS CUI [1]
C0014822
no other concurrent chemotherapy
Description

chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
no concurrent dexamethasone or other steroidal antiemetics
Description

no concurrent dexamethasone or other steroidal antiemetics

Data type

boolean

Alias
UMLS CUI [1]
C0011777
UMLS CUI [2]
C0001617
no concurrent hormone therapy, except for non-disease-related conditions
Description

hormone therapy

Data type

boolean

Alias
UMLS CUI [1]
C0279025

Similar models

Eligibility Leukemia NCT00003545

  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00003545
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
histologically confirmed diagnosis of t-cell acute lymphoblastic leukemia (all) or lymphoblastic lymphoma (lbl)
Item
histologically confirmed diagnosis of t-cell acute lymphoblastic leukemia (all) or lymphoblastic lymphoma (lbl)
boolean
C0023449 (UMLS CUI [1])
C0278721 (UMLS CUI [2])
leukemia or lymphoma cells should express at least two of the following cell surface antigens: cd1a, cd2, cd3 (surface or cytoplasmic), cd4, cd5, cd7, and cd8
Item
leukemia or lymphoma cells should express at least two of the following cell surface antigens: cd1a, cd2, cd3 (surface or cytoplasmic), cd4, cd5, cd7, and cd8
boolean
C0003339 (UMLS CUI [1])
leukemia cells should be negative for myeloperoxidase or sudan black b if the only t cell markers present are cd4 and cd7, the leukemic cells should be demonstrated to lack the myeloid markers cd33 and/or cd13
Item
leukemia cells should be negative for myeloperoxidase or sudan black b if the only t cell markers present are cd4 and cd7, the leukemic cells should be demonstrated to lack the myeloid markers cd33 and/or cd13
boolean
C2698399 (UMLS CUI [1])
C0075489 (UMLS CUI [2])
C0003339 (UMLS CUI [3])
induction
Item
refractory to at least one induction treatment regimen or in first or later relapse after achieving a complete remission
boolean
C3179010 (UMLS CUI [1])
no cns leukemia or lymphoma requiring intrathecal or craniospinal radiotherapy
Item
no cns leukemia or lymphoma requiring intrathecal or craniospinal radiotherapy
boolean
C1269563 (UMLS CUI [1])
age
Item
age: 16 and over
boolean
C0001779 (UMLS CUI [1])
bilirubin
Item
bilirubin no greater than 2 times upper limit of normal (unless due to leukemia)
boolean
C1278039 (UMLS CUI [1])
creatinine clearance
Item
creatinine clearance at least 50 ml/min (unless due to leukemia)
boolean
C0373595 (UMLS CUI [1])
neurologic toxicity
Item
no neurologic toxicity of grade 3 or greater during prior treatment of all/lbl
boolean
C0600688 (UMLS CUI [1])
neuropathy
Item
no preexisting neuropathy of grade 2 or greater regardless of causality
boolean
C0442874 (UMLS CUI [1])
seizure disorder
Item
no history of seizure disorder
boolean
C0036572 (UMLS CUI [1])
not pregnant or nursing
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
contraception
Item
fertile patients must use effective contraception
boolean
C0700589 (UMLS CUI [1])
erythropoietin
Item
no concurrent erythropoietin
boolean
C0014822 (UMLS CUI [1])
chemotherapy
Item
no other concurrent chemotherapy
boolean
C0392920 (UMLS CUI [1])
no concurrent dexamethasone or other steroidal antiemetics
Item
no concurrent dexamethasone or other steroidal antiemetics
boolean
C0011777 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
hormone therapy
Item
no concurrent hormone therapy, except for non-disease-related conditions
boolean
C0279025 (UMLS CUI [1])

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