0 Évaluations
ID

30561

Description

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

Lien

https://clinicaltrials.gov/show/NCT00737529

Mots-clés

Versions (1)
  1. 14/06/2018 14/06/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

14 juin 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

  • Plus récent
  • Plus ancien
  • Favori
  • Plus récent
    • Plus récent
    • Plus ancien
    • Favori

    Aucun commentaire

    Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

    Eligibility Mantle Cell Lymphoma NCT00737529

    Anglais

    Eligibility Mantle Cell Lymphoma NCT00737529

    1 Formulaires  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    biopsy proven mantle cell lymphoma
    Description

    Mantle cell lymphoma

    Type de données

    boolean

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

    Bortezomib | Recurrent disease | Refractory Disease | Progressive Disease

    Type de données

    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
    Description

    Measurable Disease Cross-sectional imaging CT

    Type de données

    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
    Description

    ECOG performance status

    Type de données

    boolean

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

    Contraceptive methods Willing

    Type de données

    boolean

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

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    any of the following laboratory abnormalities
    Description

    Laboratory test result abnormal

    Type de données

    boolean

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

    Absolute neutrophil count

    Type de données

    boolean

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

    Platelet Count measurement

    Type de données

    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.
    Description

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

    Type de données

    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.
    Description

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

    Type de données

    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
    Description

    Estimation of creatinine clearance by Cockcroft-Gault formula

    Type de données

    boolean

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

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

    Type de données

    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
    Description

    Central nervous system lymphoma

    Type de données

    boolean

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

    DVT prophylaxis Unwilling | DVT prophylaxis Unable

    Type de données

    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
    Description

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

    Type de données

    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
    Description

    HIV Seropositivity | Hepatitis B | Hepatitis C

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0019699
    UMLS CUI [2]
    C0019163
    UMLS CUI [3]
    C0019196
    Retour au début de la page

    Similar models

    Eligibility Mantle Cell Lymphoma NCT00737529

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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])
    Retour au début de la page 

    Aide

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial