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ID

30561

Beschrijving

A Study to Determine the Efficacy and Safety of Lenalidomide in Patients With Mantle Cell NHL Who Have Relapsed or Progressed After Treatment With Bortezomib or Are Refractory to Bortezomib. The "EMERGE" Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00737529

Link

https://clinicaltrials.gov/show/NCT00737529

Trefwoorden

Versies (1)
  1. 14/06/18 14/06/18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

14 giugno 2018

DOI

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Licentie

Creative Commons BY 4.0
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    Eligibility Mantle Cell Lymphoma NCT00737529

    Engels

    Eligibility Mantle Cell Lymphoma NCT00737529

    1 Formulieren  
    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    biopsy proven mantle cell lymphoma
    Beschrijving

    Mantle cell lymphoma

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0334634
    patients must have documents relapsed, refractory or pd after treatment with bortezomib
    Beschrijving

    Bortezomib | Recurrent disease | Refractory Disease | Progressive Disease

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1176309
    UMLS CUI [2]
    C0277556
    UMLS CUI [3]
    C1514815
    UMLS CUI [4]
    C1335499
    must have measureable disease on cross sectional imaging by ct
    Beschrijving

    Measurable Disease Cross-sectional imaging CT

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041
    UMLS CUI [1,2]
    C3824793
    UMLS CUI [1,3]
    C0040405
    eastern cooperative oncology group (ecog) performance score 0,1 or 2
    Beschrijving

    ECOG performance status

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    willing to follow pregnancy precautions
    Beschrijving

    Contraceptive methods Willing

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0700589
    UMLS CUI [1,2]
    C0600109
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    any of the following laboratory abnormalities
    Beschrijving

    Laboratory test result abnormal

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0438215
    absolute neutrophil count (anc) < 1,500 cells/mm3 (1.5 x 109/l)
    Beschrijving

    Absolute neutrophil count

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0948762
    platelet count < 60,000/mm3 (60 x 109/l)
    Beschrijving

    Platelet Count measurement

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0032181
    serum aspartate transaminase/serum glutamic oxaloacetic transaminase(ast/sgot) or alanine transaminase/serum glutamic pyruvic transaminase (alt/sgpt) > 3.0 x upper limit of normal (uln), except in patients with documented liver involvement by lymphoma.
    Beschrijving

    Aspartate aminotransferase increased | Alanine aminotransferase increased | Exception Liver Involvement with Lymphoma

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0151904
    UMLS CUI [2]
    C0151905
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0023884
    UMLS CUI [3,3]
    C1314939
    UMLS CUI [3,4]
    C0024299
    serum total bilirubin > 1.5 x uln, except in cases of gilbert's syndrome and documented liver involvement by lymphoma.
    Beschrijving

    Elevated total bilirubin | Exception Gilbert Disease | Exception Liver Involvement with Lymphoma

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0741494
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0017551
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0023884
    UMLS CUI [3,3]
    C1314939
    UMLS CUI [3,4]
    C0024299
    calculated creatinine clearance (cockcroft-gault formula) of < 30 ml /min
    Beschrijving

    Estimation of creatinine clearance by Cockcroft-Gault formula

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2711451
    patients who are candidates for high dose chemotherapy/allogeneic stem cell transplant are not eligible
    Beschrijving

    Patient need for High-dose chemotherapy | Patient need for Allogeneic Stem Cell Transplantation

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0686904
    UMLS CUI [1,2]
    C1328050
    UMLS CUI [2,1]
    C0686904
    UMLS CUI [2,2]
    C2242529
    history of active central nervous system (cns) lymphoma within the previous 3 months
    Beschrijving

    Central nervous system lymphoma

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0742472
    subjects not willing or unable to take deep vein thrombosis (dvt) prophylaxis
    Beschrijving

    DVT prophylaxis Unwilling | DVT prophylaxis Unable

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0853245
    UMLS CUI [1,2]
    C0558080
    UMLS CUI [2,1]
    C0853245
    UMLS CUI [2,2]
    C1299582
    prior history of malignancies, other than mcl, unless the patient has been free of the disease for ≥ 3 years
    Beschrijving

    Malignant Neoplasms | Exception Mantle cell lymphoma | Exception Disease Free of

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0334634
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0012634
    UMLS CUI [3,3]
    C0332296
    positive human immunodeficiency virus (hiv) or active hepatitis b or c
    Beschrijving

    HIV Seropositivity | Hepatitis B | Hepatitis C

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0019699
    UMLS CUI [2]
    C0019163
    UMLS CUI [3]
    C0019196
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    Similar models

    Eligibility Mantle Cell Lymphoma NCT00737529

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Mantle cell lymphoma
    Item
    biopsy proven mantle cell lymphoma
    boolean
    C0334634 (UMLS CUI [1])
    Bortezomib | Recurrent disease | Refractory Disease | Progressive Disease
    Item
    patients must have documents relapsed, refractory or pd after treatment with bortezomib
    boolean
    C1176309 (UMLS CUI [1])
    C0277556 (UMLS CUI [2])
    C1514815 (UMLS CUI [3])
    C1335499 (UMLS CUI [4])
    Measurable Disease Cross-sectional imaging CT
    Item
    must have measureable disease on cross sectional imaging by ct
    boolean
    C1513041 (UMLS CUI [1,1])
    C3824793 (UMLS CUI [1,2])
    C0040405 (UMLS CUI [1,3])
    ECOG performance status
    Item
    eastern cooperative oncology group (ecog) performance score 0,1 or 2
    boolean
    C1520224 (UMLS CUI [1])
    Contraceptive methods Willing
    Item
    willing to follow pregnancy precautions
    boolean
    C0700589 (UMLS CUI [1,1])
    C0600109 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    Laboratory test result abnormal
    Item
    any of the following laboratory abnormalities
    boolean
    C0438215 (UMLS CUI [1])
    Absolute neutrophil count
    Item
    absolute neutrophil count (anc) < 1,500 cells/mm3 (1.5 x 109/l)
    boolean
    C0948762 (UMLS CUI [1])
    Platelet Count measurement
    Item
    platelet count < 60,000/mm3 (60 x 109/l)
    boolean
    C0032181 (UMLS CUI [1])
    Aspartate aminotransferase increased | Alanine aminotransferase increased | Exception Liver Involvement with Lymphoma
    Item
    serum aspartate transaminase/serum glutamic oxaloacetic transaminase(ast/sgot) or alanine transaminase/serum glutamic pyruvic transaminase (alt/sgpt) > 3.0 x upper limit of normal (uln), except in patients with documented liver involvement by lymphoma.
    boolean
    C0151904 (UMLS CUI [1])
    C0151905 (UMLS CUI [2])
    C1705847 (UMLS CUI [3,1])
    C0023884 (UMLS CUI [3,2])
    C1314939 (UMLS CUI [3,3])
    C0024299 (UMLS CUI [3,4])
    Elevated total bilirubin | Exception Gilbert Disease | Exception Liver Involvement with Lymphoma
    Item
    serum total bilirubin > 1.5 x uln, except in cases of gilbert's syndrome and documented liver involvement by lymphoma.
    boolean
    C0741494 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0017551 (UMLS CUI [2,2])
    C1705847 (UMLS CUI [3,1])
    C0023884 (UMLS CUI [3,2])
    C1314939 (UMLS CUI [3,3])
    C0024299 (UMLS CUI [3,4])
    Estimation of creatinine clearance by Cockcroft-Gault formula
    Item
    calculated creatinine clearance (cockcroft-gault formula) of < 30 ml /min
    boolean
    C2711451 (UMLS CUI [1])
    Patient need for High-dose chemotherapy | Patient need for Allogeneic Stem Cell Transplantation
    Item
    patients who are candidates for high dose chemotherapy/allogeneic stem cell transplant are not eligible
    boolean
    C0686904 (UMLS CUI [1,1])
    C1328050 (UMLS CUI [1,2])
    C0686904 (UMLS CUI [2,1])
    C2242529 (UMLS CUI [2,2])
    Central nervous system lymphoma
    Item
    history of active central nervous system (cns) lymphoma within the previous 3 months
    boolean
    C0742472 (UMLS CUI [1])
    DVT prophylaxis Unwilling | DVT prophylaxis Unable
    Item
    subjects not willing or unable to take deep vein thrombosis (dvt) prophylaxis
    boolean
    C0853245 (UMLS CUI [1,1])
    C0558080 (UMLS CUI [1,2])
    C0853245 (UMLS CUI [2,1])
    C1299582 (UMLS CUI [2,2])
    Malignant Neoplasms | Exception Mantle cell lymphoma | Exception Disease Free of
    Item
    prior history of malignancies, other than mcl, unless the patient has been free of the disease for ≥ 3 years
    boolean
    C0006826 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0334634 (UMLS CUI [2,2])
    C1705847 (UMLS CUI [3,1])
    C0012634 (UMLS CUI [3,2])
    C0332296 (UMLS CUI [3,3])
    HIV Seropositivity | Hepatitis B | Hepatitis C
    Item
    positive human immunodeficiency virus (hiv) or active hepatitis b or c
    boolean
    C0019699 (UMLS CUI [1])
    C0019163 (UMLS CUI [2])
    C0019196 (UMLS CUI [3])
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