ID

14595

Description

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00408005

Link

https://clinicaltrials.gov/show/NCT00408005

Keywords

Versions (1)
  1. 4/22/16 4/22/16 -
Uploaded on

April 22, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Adult T Acute Lymphoblastic Leukemia NCT00408005

English

Eligibility Adult T Acute Lymphoblastic Leukemia NCT00408005

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
t-all patients must be enrolled on aall08b1 prior to treatment and enrollment on aall0434
Description

t-all patients

Data type

boolean

Alias
UMLS CUI [1]
C0023493
patients must have newly diagnosed t-all or t-lineage lymphoblastic lymphoma (t-nhl) stage ii-iv; b-lineage lymphoblastic lymphoma will not be eligible for this study; a diagnosis of t-all is established when leukemic blasts lack myeloperoxidase or evidence of b-lineage derivation (cluster of differentiation [cd]19/cd22/cd20), and express either surface or cytoplasmic cd3 or two or more of the antigens cd8, cd7, cd5, cd4, cd2 or cd1a; if surface cd3 is expressed on all leukemic cells, additional markers of immaturity, including transmission disequilibrium test (tdt), cd34 or cd99 will be assessed for expression; cases with uncertain expression will receive additional review within the appropriate children's oncology group (cog) reference laboratory
Description

t-all or t-lineage lymphoblastic lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C1332213
for t-nhl patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to t-all; for tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of t-nhl defined by the submitting institution will be accepted
Description

t-nhl patients with tissue available for flow cytometry

Data type

boolean

Alias
UMLS CUI [1]
C1301140
UMLS CUI [2]
C0016263
prior therapy restrictions
Description

prior therapy restrictions

Data type

boolean

Alias
UMLS CUI [1]
C0443288
patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and/or it cytarabine
Description

ID.6

Data type

boolean

if 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 it therapy
Description

cytarabine

Data type

boolean

Alias
UMLS CUI [1]
C0010711
patients diagnosed as having t-nhl or t-all with respiratory distress or hyperleukocytosis may require steroids prior to the initiation of additional systemic therapy; they are eligible for aall0434 and will be stratified, based on the initial complete blood count (cbc); steroid pretreatment may alter the risk group assessment; if the t-all patient's clinical status precludes a lumbar puncture within 48 hours of the initiation of steroid therapy, t-all patients cannot be classified as low risk and will be intermediate or high risk based on the results of the day 29 marrow as above; patients with t-nhl who receive steroid pre-treatment will be classified as high risk; the dose and duration of previous steroid therapy should be carefully documented
Description

hyperleukocytosis or respiratory distress

Data type

boolean

Alias
UMLS CUI [1]
C3805210
UMLS CUI [2]
C0476273
for the management of airway compromise, patients who have received emergent chest irradiation up to 600 cgy will be eligible for this study
Description

emergent chest irradiation

Data type

boolean

Alias
UMLS CUI [1]
C2064934
patients with a prior seizure disorder requiring anti-convulsant therapy are not eligible to receive nelarabine; in addition, patients with pre-existing grade 2 (or greater) peripheral neurotoxicity, as determined prior to induction treatment by the treating physician or a neurologist, are not eligible to receive nelarabine; these restrictions in eligibility are designed to prevent excessive nelarabine-induced central and peripheral neurotoxicity in at-risk patients; for the purposes of this study, this includes any patient that has received anticonvulsant therapy to prevent/treat seizures in the prior two years
Description

seizure

Data type

boolean

Alias
UMLS CUI [1]
C0036572
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating females
Description

pregnant or lactating

Data type

boolean

Alias
UMLS CUI [1,1]
C0549206
UMLS CUI [1,2]
C0006147
patients with down syndrome
Description

down syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0013080
b-precursor lymphoblastic lymphoma
Description

b-precursor lymphoblastic lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0855146
morphologically unclassifiable lymphoma
Description

morphologically unclassifiable lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0024306
absence of both b-cell and t-cell phenotype markers in a case submitted as lymphoblastic lymphoma
Description

b-cell and t-cell phenotype

Data type

boolean

Alias
UMLS CUI [1]
C3472616
cns-positive or testicular involvement
Description

cns-positive or testicular involvement

Data type

boolean

Alias
UMLS CUI [1]
C0085136
UMLS CUI [2]
C0153594
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Similar models

Eligibility Adult T Acute Lymphoblastic Leukemia NCT00408005

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
t-all patients
Item
t-all patients must be enrolled on aall08b1 prior to treatment and enrollment on aall0434
boolean
C0023493 (UMLS CUI [1])
t-all or t-lineage lymphoblastic lymphoma
Item
patients must have newly diagnosed t-all or t-lineage lymphoblastic lymphoma (t-nhl) stage ii-iv; b-lineage lymphoblastic lymphoma will not be eligible for this study; a diagnosis of t-all is established when leukemic blasts lack myeloperoxidase or evidence of b-lineage derivation (cluster of differentiation [cd]19/cd22/cd20), and express either surface or cytoplasmic cd3 or two or more of the antigens cd8, cd7, cd5, cd4, cd2 or cd1a; if surface cd3 is expressed on all leukemic cells, additional markers of immaturity, including transmission disequilibrium test (tdt), cd34 or cd99 will be assessed for expression; cases with uncertain expression will receive additional review within the appropriate children's oncology group (cog) reference laboratory
boolean
C1332213 (UMLS CUI [1])
t-nhl patients with tissue available for flow cytometry
Item
for t-nhl patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to t-all; for tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of t-nhl defined by the submitting institution will be accepted
boolean
C1301140 (UMLS CUI [1])
C0016263 (UMLS CUI [2])
prior therapy restrictions
Item
prior therapy restrictions
boolean
C0443288 (UMLS CUI [1])
ID.6
Item
patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and/or it cytarabine
boolean
cytarabine
Item
if 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 it therapy
boolean
C0010711 (UMLS CUI [1])
hyperleukocytosis or respiratory distress
Item
patients diagnosed as having t-nhl or t-all with respiratory distress or hyperleukocytosis may require steroids prior to the initiation of additional systemic therapy; they are eligible for aall0434 and will be stratified, based on the initial complete blood count (cbc); steroid pretreatment may alter the risk group assessment; if the t-all patient's clinical status precludes a lumbar puncture within 48 hours of the initiation of steroid therapy, t-all patients cannot be classified as low risk and will be intermediate or high risk based on the results of the day 29 marrow as above; patients with t-nhl who receive steroid pre-treatment will be classified as high risk; the dose and duration of previous steroid therapy should be carefully documented
boolean
C3805210 (UMLS CUI [1])
C0476273 (UMLS CUI [2])
emergent chest irradiation
Item
for the management of airway compromise, patients who have received emergent chest irradiation up to 600 cgy will be eligible for this study
boolean
C2064934 (UMLS CUI [1])
seizure
Item
patients with a prior seizure disorder requiring anti-convulsant therapy are not eligible to receive nelarabine; in addition, patients with pre-existing grade 2 (or greater) peripheral neurotoxicity, as determined prior to induction treatment by the treating physician or a neurologist, are not eligible to receive nelarabine; these restrictions in eligibility are designed to prevent excessive nelarabine-induced central and peripheral neurotoxicity in at-risk patients; for the purposes of this study, this includes any patient that has received anticonvulsant therapy to prevent/treat seizures in the prior two years
boolean
C0036572 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pregnant or lactating
Item
pregnant or lactating females
boolean
C0549206 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
down syndrome
Item
patients with down syndrome
boolean
C0013080 (UMLS CUI [1])
b-precursor lymphoblastic lymphoma
Item
b-precursor lymphoblastic lymphoma
boolean
C0855146 (UMLS CUI [1])
morphologically unclassifiable lymphoma
Item
morphologically unclassifiable lymphoma
boolean
C0024306 (UMLS CUI [1])
b-cell and t-cell phenotype
Item
absence of both b-cell and t-cell phenotype markers in a case submitted as lymphoblastic lymphoma
boolean
C3472616 (UMLS CUI [1])
cns-positive or testicular involvement
Item
cns-positive or testicular involvement
boolean
C0085136 (UMLS CUI [1])
C0153594 (UMLS CUI [2])
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