Informationen:
Fehler:
ID
18099
Beschreibung
VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00063713
Link
https://clinicaltrials.gov/show/NCT00063713
Stichworte
Versionen (1)
- 19.10.16 19.10.16 -
Hochgeladen am
19. Oktober 2016
DOI
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Lizenz
Creative Commons BY 4.0
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Eligibility Mantle Cell Lymphoma NCT00063713
Eligibility Mantle Cell Lymphoma NCT00063713
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Mantle Cell Lymphoma NCT00063713
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Mantle cell lymphoma
Item
confirmed diagnosis of mantle cell lymphoma
boolean
C0334634 (UMLS CUI [1])
Recurrent disease | Progressive Disease | cancer treatment Quantity | Anthracycline | Mitoxantrone | New Lesion | Lesion Progressive Evidence of
Item
documented relapse or progressive disease following 1 or 2 prior lines of anti-cancer therapy. at least one of those regimens must have included an anthracycline or mitoxantrone. relapsed or progressive disease, since last therapy must be documented by new lesions or objective evidence of the progression of existing lesions.
boolean
C0277556 (UMLS CUI [1])
C1335499 (UMLS CUI [2])
C0920425 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0003234 (UMLS CUI [4])
C0026259 (UMLS CUI [5])
C2986548 (UMLS CUI [6])
C0221198 (UMLS CUI [7,1])
C0205329 (UMLS CUI [7,2])
C0332120 (UMLS CUI [7,3])
C1335499 (UMLS CUI [2])
C0920425 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0003234 (UMLS CUI [4])
C0026259 (UMLS CUI [5])
C2986548 (UMLS CUI [6])
C0221198 (UMLS CUI [7,1])
C0205329 (UMLS CUI [7,2])
C0332120 (UMLS CUI [7,3])
Measurable Disease Site Quantity | Evaluable Disease Site Quantity
Item
at least 1 measurable or evaluable site of disease
boolean
C1513041 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1516986 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1515974 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1516986 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Informed Consent
Item
voluntary consent
boolean
C0021430 (UMLS CUI [1])
Velcade
Item
previous treatment with velcade
boolean
C1174739 (UMLS CUI [1])
Therapies, Investigational | cancer treatment
Item
any experimental or anti-cancer therapy within 3 weeks before the first dose of study drug
boolean
C0949266 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
C0920425 (UMLS CUI [2])
Therapeutic radiology procedure
Item
radiation therapy within 3 weeks before the first dose of study drug
boolean
C1522449 (UMLS CUI [1])
major surgery
Item
major surgery with 2 weeks before the first dose of study drug
boolean
C0679637 (UMLS CUI [1])
rituximab | Campath | Monoclonal antibody unconjugated therapy
Item
rituximab, campath, or other unconjugated therapeutic antibody within 4 weeks before the first dose of study drug
boolean
C0393022 (UMLS CUI [1])
C0939276 (UMLS CUI [2])
C0854644 (UMLS CUI [3])
C0939276 (UMLS CUI [2])
C0854644 (UMLS CUI [3])
Radioimmunotherapy | Toxin Immunoconjugates | Zevalin | Bexxar
Item
radioimmunotherapy or other toxin immunoconjugates such as zevalin or bexxar within 10 weeks before the first dose of study drug
boolean
C0085101 (UMLS CUI [1])
C0040549 (UMLS CUI [2,1])
C0243020 (UMLS CUI [2,2])
C0919274 (UMLS CUI [3])
C0919272 (UMLS CUI [4])
C0040549 (UMLS CUI [2,1])
C0243020 (UMLS CUI [2,2])
C0919274 (UMLS CUI [3])
C0919272 (UMLS CUI [4])
Allergic Reaction Boron Compounds | Mannitol allergy
Item
history of allergic reactions to boron or mannitol compounds
boolean
C1527304 (UMLS CUI [1,1])
C0006031 (UMLS CUI [1,2])
C0571922 (UMLS CUI [2])
C0006031 (UMLS CUI [1,2])
C0571922 (UMLS CUI [2])
Malignant Neoplasms | Mantle cell lymphoma
Item
diagnosed or treated for another malignancy other than mantle cell lymphoma with 5 years before the first dose of study drug
boolean
C0006826 (UMLS CUI [1])
C0334634 (UMLS CUI [2])
C0334634 (UMLS CUI [2])
Sepsis Requirement Therapeutic procedure
Item
active systemic infection requiring treatment
boolean
C0243026 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Pregnancy Pregnancy Test | Breast Feeding | Postmenopausal state | Female Sterilization
Item
women patients must not be pregnant or breast-feeding, confirmed through pregnancy test obtained during screening (this test is not required for women who are post-menopausal or surgically sterile)
boolean
C0032961 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
C0032976 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
Illness Serious Interferes with Study Subject Participation Status | Mental disorder Interferes with Study Subject Participation Status
Item
serious medical or psychiatric illness likely to interfere with participation in this clinical study
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
Study Subject Participation Status | Investigational New Drugs
Item
concurrent treatment with another investigational drug or participation in non-treatment studies is not allowed if it interferes with participation in this clinical study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0013230 (UMLS CUI [2])