ID

30225

Descrição

Combination Chemotherapy in Treating Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01005758

Link

https://clinicaltrials.gov/show/NCT01005758

Palavras-chave

Versões (1)
  1. 22/05/2018 22/05/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

22 de maio de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Leukemia NCT01005758

Inglês

Eligibility Leukemia NCT01005758

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01005758
Criteria
Descrição

Criteria

diagnosis of acute lymphoblastic leukemia (all)
Descrição

Acute lymphocytic leukemia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023449
no known mature b-cell all*, defined by the presence of surface immunoglobulin, l3 morphology, t(8;14)(q24;q32), t(8;22), or t(2;8)
Descrição

Exclusion Burkitt Leukemia | Receptors, Antigen, B-Cell | t(8;14)(q24;q32) | Other Coding

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0006413
UMLS CUI [2]
C0034789
UMLS CUI [3]
C1515792
UMLS CUI [4]
C4331809
UMLS CUI [5]
C3846158
patients with t-cell surface markers and t(8;14)(q24;q11) are eligible note:
Descrição

T-cell surface markers | t(8;14)(q24;q11)

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0039194
UMLS CUI [1,2]
C0699040
UMLS CUI [1,3]
C0005516
UMLS CUI [2]
C1515791
*patients with mature b-cell all will be removed from the study as soon as that diagnosis is made.
Descrição

Exclusion Burkitt Leukemia

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0006413
no secondary all (i.e., all arising after another malignancy)
Descrição

Exclusion Acute lymphocytic leukemia Secondary

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0023449
UMLS CUI [1,3]
C0175668
patient characteristics:
Descrição

Client Characteristics

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0815172
not pregnant or nursing
Descrição

Pregnancy Absent | Breast Feeding Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
negative pregnancy test
Descrição

Pregnancy test negative

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0427780
fertile patients must use effective contraception
Descrição

Fertility Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
no known hiv positivity (hiv testing is not required)
Descrição

HIV Seropositivity Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019699
UMLS CUI [1,2]
C0332197
no comorbid medical condition that would, in the investigator's opinion, make participation in this study and adherence to the study guidelines a compromise to the study objectives
Descrição

Exclusion | Comorbidity compromises Study Subject Participation Status | Comorbidity compromises Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C0525058
no active psychiatric or mental illness that would make giving informed consent or careful clinical follow-up unlikely
Descrição

Exclusion | Mental disorders Informed Consent Unlikely | Mental disorders Follow-up Unlikely

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0021430
UMLS CUI [2,3]
C0750558
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C3274571
UMLS CUI [3,3]
C0750558
prior concurrent therapy:
Descrição

Therapeutic procedure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0087111
no prior anti-leukemic therapy except ≤ 1 week of steroids, emergent radiotherapy to the mediastinum, hydroxyurea, or emergent leukapheresis
Descrição

Exclusion | Therapeutic procedure Leukemia Related | Exception Steroids | Exception Radiotherapy to mediastinum Emergency | Exception Hydroxyurea | Exception Leukapheresis Emergency

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0023418
UMLS CUI [2,3]
C0439849
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0038317
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C4049191
UMLS CUI [4,3]
C0013956
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0020402
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0023416
UMLS CUI [6,3]
C0013956
patients who have received steroids within the past 7 days are eligible but will not receive steroid prophase therapy on study
Descrição

Steroids Recently

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C0332185
no concurrent chronic steroids or anti-metabolite therapy
Descrição

Exclusion Criteria | Steroids chronic | Antimetabolites chronic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0038317
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C0003376
UMLS CUI [3,2]
C0205191
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Similar models

Eligibility Leukemia NCT01005758

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01005758
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Acute lymphocytic leukemia
Item
diagnosis of acute lymphoblastic leukemia (all)
boolean
C0023449 (UMLS CUI [1])
Exclusion Burkitt Leukemia | Receptors, Antigen, B-Cell | t(8;14)(q24;q32) | Other Coding
Item
no known mature b-cell all*, defined by the presence of surface immunoglobulin, l3 morphology, t(8;14)(q24;q32), t(8;22), or t(2;8)
boolean
C2828389 (UMLS CUI [1,1])
C0006413 (UMLS CUI [1,2])
C0034789 (UMLS CUI [2])
C1515792 (UMLS CUI [3])
C4331809 (UMLS CUI [4])
C3846158 (UMLS CUI [5])
T-cell surface markers | t(8;14)(q24;q11)
Item
patients with t-cell surface markers and t(8;14)(q24;q11) are eligible note:
boolean
C0039194 (UMLS CUI [1,1])
C0699040 (UMLS CUI [1,2])
C0005516 (UMLS CUI [1,3])
C1515791 (UMLS CUI [2])
Exclusion Burkitt Leukemia
Item
*patients with mature b-cell all will be removed from the study as soon as that diagnosis is made.
boolean
C2828389 (UMLS CUI [1,1])
C0006413 (UMLS CUI [1,2])
Exclusion Acute lymphocytic leukemia Secondary
Item
no secondary all (i.e., all arising after another malignancy)
boolean
C2828389 (UMLS CUI [1,1])
C0023449 (UMLS CUI [1,2])
C0175668 (UMLS CUI [1,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Pregnancy Absent | Breast Feeding Absent
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
HIV Seropositivity Absent
Item
no known hiv positivity (hiv testing is not required)
boolean
C0019699 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Exclusion | Comorbidity compromises Study Subject Participation Status | Comorbidity compromises Protocol Compliance
Item
no comorbid medical condition that would, in the investigator's opinion, make participation in this study and adherence to the study guidelines a compromise to the study objectives
boolean
C2828389 (UMLS CUI [1])
C0009488 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
Exclusion | Mental disorders Informed Consent Unlikely | Mental disorders Follow-up Unlikely
Item
no active psychiatric or mental illness that would make giving informed consent or careful clinical follow-up unlikely
boolean
C2828389 (UMLS CUI [1])
C0004936 (UMLS CUI [2,1])
C0021430 (UMLS CUI [2,2])
C0750558 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C3274571 (UMLS CUI [3,2])
C0750558 (UMLS CUI [3,3])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Exclusion | Therapeutic procedure Leukemia Related | Exception Steroids | Exception Radiotherapy to mediastinum Emergency | Exception Hydroxyurea | Exception Leukapheresis Emergency
Item
no prior anti-leukemic therapy except ≤ 1 week of steroids, emergent radiotherapy to the mediastinum, hydroxyurea, or emergent leukapheresis
boolean
C2828389 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0023418 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0038317 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C4049191 (UMLS CUI [4,2])
C0013956 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0020402 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0023416 (UMLS CUI [6,2])
C0013956 (UMLS CUI [6,3])
Steroids Recently
Item
patients who have received steroids within the past 7 days are eligible but will not receive steroid prophase therapy on study
boolean
C0038317 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Exclusion Criteria | Steroids chronic | Antimetabolites chronic
Item
no concurrent chronic steroids or anti-metabolite therapy
boolean
C0680251 (UMLS CUI [1])
C0038317 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0003376 (UMLS CUI [3,1])
C0205191 (UMLS CUI [3,2])
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