ID

14457

Description

Chemotherapy, Imatinib Mesylate, and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00039377

Link

https://clinicaltrials.gov/show/NCT00039377

Keywords

  1. 4/16/16 4/16/16 -
Uploaded on

April 16, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Adult Acute Lymphoblastic Leukemia in Remission NCT00039377

Eligibility Adult Acute Lymphoblastic Leukemia in Remission NCT00039377

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
unequivocal histologic diagnosis of all
Description

diagnosis of all

Data type

boolean

Alias
UMLS CUI [1]
C0279862
detection of the t(9;22)(q34;q11) or 3-way variant by metaphase cytogenetics or bcr-abl positive by molecular analysis (rt-pcr or fluorescence in situ hybridization [fish})
Description

Philadelphia chromosome

Data type

boolean

Alias
UMLS CUI [1]
C1515809
complete or partial remission following one course of induction chemotherapy with an intensive 4 or 5 drug regimen (with or without imatinib mesylate) on a calgb or swog all protocol for previously untreated all patients
Description

Patient in partial remission

Data type

boolean

Alias
UMLS CUI [1]
C1562651
the double induction regimen of swog s0333 is considered to be one course of induction chemotherapy for the purpose of this eligibility criterion; therefore, patients from s0333 may be eligible for this study only after completing the entire double induction regimen
Description

swog s0333

Data type

boolean

Alias
UMLS CUI [1]
C1519429
complete or partial remission following one course of therapy on any standard induction regimen (with or without imatinib mesylate) without prior enrollment on a cooperative group frontline protocol; in these instances, documentation of philadelphia chromosome (ph)+ positivity may occur outside a calgb or swog laboratory
Description

standard induction regimen

Data type

boolean

Alias
UMLS CUI [1]
C1880213
calgb institutions must enroll patients on calgb 9862 and submission of an initial sample for the companion trial must occur at time of enrollment on calgb c10001; enrollment on companion studies calgb 8461 and 9665 is not required
Description

Cancer and Leukemia Group B

Data type

boolean

Alias
UMLS CUI [1]
C1516238
no more than six weeks of prior imatinib mesylate during induction therapy before study enrollment
Description

imatinib

Data type

boolean

Alias
UMLS CUI [1]
C0935989
non-pregnant and non-nursing; treatment under this protocol would expose an unborn child to significant risks; women and men of reproductive potential should agree to use an effective means of birth control and contraception should continue for three months after the last dose of imatinib mesylate (gleevec) to allow complete clearance of drug and its principle metabolites from the body; in women of childbearing potential, a pregnancy test will be required at study entry
Description

Not pregnant

Data type

boolean

Alias
UMLS CUI [1]
C0232973

Similar models

Eligibility Adult Acute Lymphoblastic Leukemia in Remission NCT00039377

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
diagnosis of all
Item
unequivocal histologic diagnosis of all
boolean
C0279862 (UMLS CUI [1])
Philadelphia chromosome
Item
detection of the t(9;22)(q34;q11) or 3-way variant by metaphase cytogenetics or bcr-abl positive by molecular analysis (rt-pcr or fluorescence in situ hybridization [fish})
boolean
C1515809 (UMLS CUI [1])
Patient in partial remission
Item
complete or partial remission following one course of induction chemotherapy with an intensive 4 or 5 drug regimen (with or without imatinib mesylate) on a calgb or swog all protocol for previously untreated all patients
boolean
C1562651 (UMLS CUI [1])
swog s0333
Item
the double induction regimen of swog s0333 is considered to be one course of induction chemotherapy for the purpose of this eligibility criterion; therefore, patients from s0333 may be eligible for this study only after completing the entire double induction regimen
boolean
C1519429 (UMLS CUI [1])
standard induction regimen
Item
complete or partial remission following one course of therapy on any standard induction regimen (with or without imatinib mesylate) without prior enrollment on a cooperative group frontline protocol; in these instances, documentation of philadelphia chromosome (ph)+ positivity may occur outside a calgb or swog laboratory
boolean
C1880213 (UMLS CUI [1])
Cancer and Leukemia Group B
Item
calgb institutions must enroll patients on calgb 9862 and submission of an initial sample for the companion trial must occur at time of enrollment on calgb c10001; enrollment on companion studies calgb 8461 and 9665 is not required
boolean
C1516238 (UMLS CUI [1])
imatinib
Item
no more than six weeks of prior imatinib mesylate during induction therapy before study enrollment
boolean
C0935989 (UMLS CUI [1])
Not pregnant
Item
non-pregnant and non-nursing; treatment under this protocol would expose an unborn child to significant risks; women and men of reproductive potential should agree to use an effective means of birth control and contraception should continue for three months after the last dose of imatinib mesylate (gleevec) to allow complete clearance of drug and its principle metabolites from the body; in women of childbearing potential, a pregnancy test will be required at study entry
boolean
C0232973 (UMLS CUI [1])

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