ID

17874

Beschrijving

Use and Tolerability of Imatinib Mesylate (Gleevec) in Leukemia Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00386373

Link

https://clinicaltrials.gov/show/NCT00386373

Trefwoorden

Versies (2)
  1. 06-10-16 06-10-16 -
  2. 06-10-16 06-10-16 -
Geüploaded op

6 oktober 2016

DOI

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Licentie

Creative Commons BY-NC 3.0
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Eligibility Leukemia NCT00386373

Engels

Eligibility Leukemia NCT00386373

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00386373
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with ph(+) cml and/or cml with bcr-abl rearrangement and diploid cytogenetics not eligible for protocols of higher priority (e.g. id02-901, dm99-081, dm97-206, etc).
Beschrijving

Philadelphia chromosome positive chronic myelogenous leukemia | Myeloid Leukemia, Chronic | BCR-ABL Fusion Gene Rearrangement | Cytogenetic Analysis Diploidy

Datatype

boolean

Alias
UMLS CUI [1]
C0279543
UMLS CUI [2]
C0023473
UMLS CUI [3,1]
C1835417
UMLS CUI [3,2]
C0017287
UMLS CUI [4,1]
C0752095
UMLS CUI [4,2]
C0012568
2. the disease must be beyond first chronic phase according to ibmtr criteria (i.e. accelerated phase, blastic phase, second chronic phase) at the time of transplant.
Beschrijving

Disease Chronic phase Ordinal number | Accelerated phase | Blastic Phase | Chronic phase second

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0457343
UMLS CUI [1,3]
C0439080
UMLS CUI [2]
C0457345
UMLS CUI [3]
C3899938
UMLS CUI [4,1]
C0457343
UMLS CUI [4,2]
C0205436
3. patients with ph(+) acute lymphocytic (or myeloid) leukemia.
Beschrijving

Philadelphia chromosome-positive acute lymphoblastic leukemia | Philadelphia chromosome positive Acute Myelocytic Leukemia

Datatype

boolean

Alias
UMLS CUI [1]
C1960397
UMLS CUI [2,1]
C0023467
UMLS CUI [2,2]
C0856536
4. patients with diploid cytogenetics but molecular evidence of bcr-abl rearrangement are also eligible.
Beschrijving

Cytogenetic Analysis Diploidy | BCR-ABL Fusion Gene Rearrangement Evidence Molecular

Datatype

boolean

Alias
UMLS CUI [1,1]
C0752095
UMLS CUI [1,2]
C0012568
UMLS CUI [2,1]
C1835417
UMLS CUI [2,2]
C0017287
UMLS CUI [2,3]
C3887511
UMLS CUI [2,4]
C1521991
5. age >/= 16 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
6. unsupported anc at least 1500 and unsupported platelet count of at least 50k following bmt.
Beschrijving

Absolute neutrophil count | Platelet Count measurement | Bone Marrow Transplantation

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0005961
7. patients may have received prior chemotherapy for their disease or be previously untreated.
Beschrijving

Prior Chemotherapy Disease | Patients untreated

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0012634
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0332155
8. patients must have received an allogeneic bone marrow or stem cell transplant. allogeneic transplant types may include matched sibling donors, mismatched related donors, or unrelated donors. all preparative regimens acceptable.
Beschrijving

Allogeneic bone marrow transplantation | Allogeneic Stem Cell Transplantation | Transplant type allogeneic | Tissue Donors Sibling HLA Matched | Living related donor Mismatch | Unrelated Donors | Preparative Regimen

Datatype

boolean

Alias
UMLS CUI [1]
C0149615
UMLS CUI [2]
C2242529
UMLS CUI [3,1]
C3840412
UMLS CUI [3,2]
C1515895
UMLS CUI [4,1]
C0040288
UMLS CUI [4,2]
C0037047
UMLS CUI [4,3]
C1548978
UMLS CUI [5,1]
C3494891
UMLS CUI [5,2]
C1881865
UMLS CUI [6]
C3179133
UMLS CUI [7]
C1882454
9. signed informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
10. zubrod status </= 3
Beschrijving

Zubrod Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C3714786
11. adequate hepatic (bilirubin </= 3 mg/dl, transaminases < 4 x upper limit of normal) and renal function (serum creatinine </= 3 mg/dl )
Beschrijving

Liver function | Serum total bilirubin measurement | Transaminases | Renal function | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0002594
UMLS CUI [4]
C0232804
UMLS CUI [5]
C0201976
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. grade iii/iv cardiac problems as defined by the nyhac
Beschrijving

Heart Diseases | New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C1275491
2. history of hypersensitivity to imatinib
Beschrijving

Hypersensitivity imatinib

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0935989
3. pregnant and lactating women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
4. hiv positive
Beschrijving

HIV Seropositivity

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
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Similar models

Eligibility Leukemia NCT00386373

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00386373
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Philadelphia chromosome positive chronic myelogenous leukemia | Myeloid Leukemia, Chronic | BCR-ABL Fusion Gene Rearrangement | Cytogenetic Analysis Diploidy
Item
1. patients with ph(+) cml and/or cml with bcr-abl rearrangement and diploid cytogenetics not eligible for protocols of higher priority (e.g. id02-901, dm99-081, dm97-206, etc).
boolean
C0279543 (UMLS CUI [1])
C0023473 (UMLS CUI [2])
C1835417 (UMLS CUI [3,1])
C0017287 (UMLS CUI [3,2])
C0752095 (UMLS CUI [4,1])
C0012568 (UMLS CUI [4,2])
Disease Chronic phase Ordinal number | Accelerated phase | Blastic Phase | Chronic phase second
Item
2. the disease must be beyond first chronic phase according to ibmtr criteria (i.e. accelerated phase, blastic phase, second chronic phase) at the time of transplant.
boolean
C0012634 (UMLS CUI [1,1])
C0457343 (UMLS CUI [1,2])
C0439080 (UMLS CUI [1,3])
C0457345 (UMLS CUI [2])
C3899938 (UMLS CUI [3])
C0457343 (UMLS CUI [4,1])
C0205436 (UMLS CUI [4,2])
Philadelphia chromosome-positive acute lymphoblastic leukemia | Philadelphia chromosome positive Acute Myelocytic Leukemia
Item
3. patients with ph(+) acute lymphocytic (or myeloid) leukemia.
boolean
C1960397 (UMLS CUI [1])
C0023467 (UMLS CUI [2,1])
C0856536 (UMLS CUI [2,2])
Cytogenetic Analysis Diploidy | BCR-ABL Fusion Gene Rearrangement Evidence Molecular
Item
4. patients with diploid cytogenetics but molecular evidence of bcr-abl rearrangement are also eligible.
boolean
C0752095 (UMLS CUI [1,1])
C0012568 (UMLS CUI [1,2])
C1835417 (UMLS CUI [2,1])
C0017287 (UMLS CUI [2,2])
C3887511 (UMLS CUI [2,3])
C1521991 (UMLS CUI [2,4])
Age
Item
5. age >/= 16 years
boolean
C0001779 (UMLS CUI [1])
Absolute neutrophil count | Platelet Count measurement | Bone Marrow Transplantation
Item
6. unsupported anc at least 1500 and unsupported platelet count of at least 50k following bmt.
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0005961 (UMLS CUI [3])
Prior Chemotherapy Disease | Patients untreated
Item
7. patients may have received prior chemotherapy for their disease or be previously untreated.
boolean
C1514457 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Allogeneic bone marrow transplantation | Allogeneic Stem Cell Transplantation | Transplant type allogeneic | Tissue Donors Sibling HLA Matched | Living related donor Mismatch | Unrelated Donors | Preparative Regimen
Item
8. patients must have received an allogeneic bone marrow or stem cell transplant. allogeneic transplant types may include matched sibling donors, mismatched related donors, or unrelated donors. all preparative regimens acceptable.
boolean
C0149615 (UMLS CUI [1])
C2242529 (UMLS CUI [2])
C3840412 (UMLS CUI [3,1])
C1515895 (UMLS CUI [3,2])
C0040288 (UMLS CUI [4,1])
C0037047 (UMLS CUI [4,2])
C1548978 (UMLS CUI [4,3])
C3494891 (UMLS CUI [5,1])
C1881865 (UMLS CUI [5,2])
C3179133 (UMLS CUI [6])
C1882454 (UMLS CUI [7])
Informed Consent
Item
9. signed informed consent
boolean
C0021430 (UMLS CUI [1])
Zubrod Performance Status
Item
10. zubrod status </= 3
boolean
C3714786 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Transaminases | Renal function | Creatinine measurement, serum
Item
11. adequate hepatic (bilirubin </= 3 mg/dl, transaminases < 4 x upper limit of normal) and renal function (serum creatinine </= 3 mg/dl )
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0002594 (UMLS CUI [3])
C0232804 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Heart Diseases | New York Heart Association Classification
Item
1. grade iii/iv cardiac problems as defined by the nyhac
boolean
C0018799 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
Hypersensitivity imatinib
Item
2. history of hypersensitivity to imatinib
boolean
C0020517 (UMLS CUI [1,1])
C0935989 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
3. pregnant and lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Seropositivity
Item
4. hiv positive
boolean
C0019699 (UMLS CUI [1])
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