Information:
Fel:
ID
35833
Beskrivning
A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Lymphomas; ODM derived from: https://clinicaltrials.gov/show/NCT02401048
Länk
https://clinicaltrials.gov/show/NCT02401048
Nyckelord
Versioner (1)
- 2019-03-26 2019-03-26 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
26 mars 2019
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Diffuse Large B-Cell Lymphoma NCT02401048
Eligibility Diffuse Large B-Cell Lymphoma NCT02401048
- StudyEvent: Eligibility
Similar models
Eligibility Diffuse Large B-Cell Lymphoma NCT02401048
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Diffuse large B-cell lymphoma recurrent | Diffuse large B-cell lymphoma refractory | Lymphoma, Follicular
Item
pathologically documented relapsed or refractory diffuse large b-cell lymphoma (dlbcl) or follicular lymphoma (fl)
boolean
C0855111 (UMLS CUI [1])
C0855112 (UMLS CUI [2])
C0024301 (UMLS CUI [3])
C0855112 (UMLS CUI [2])
C0024301 (UMLS CUI [3])
Measurable Disease Site Length CT scan
Item
measurable disease sites on ct scan (>1.5 cm in longest dimension)
boolean
C1513041 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1444754 (UMLS CUI [1,3])
C0040405 (UMLS CUI [1,4])
C1515974 (UMLS CUI [1,2])
C1444754 (UMLS CUI [1,3])
C0040405 (UMLS CUI [1,4])
Hematologic function
Item
adequate hematologic function:
boolean
C0221130 (UMLS CUI [1])
Absolute neutrophil count
Item
1. absolute neutrophil count >1500 cells/mm3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
2. platelets >50000 cells/mm3
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
3. hemoglobin >8.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Liver function | Renal function
Item
adequate hepatic and renal function:
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232804 (UMLS CUI [2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
1. ast or alt ≤2.5 x uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201836 (UMLS CUI [2])
Serum total bilirubin measurement
Item
2. bilirubin ≤1.5 x uln
boolean
C1278039 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
3. estimated creatinine clearance (cockcroft-gault) >40 ml/min
boolean
C2711451 (UMLS CUI [1])
ECOG performance status
Item
ecog 0 or 1
boolean
C1520224 (UMLS CUI [1])
Ibrutinib | BTK Inhibitor | Anti-PD1 Monoclonal Antibody | Anti-PD-L1 Monoclonal Antibody | PD-L2 Monoclonal Antibody | urelumab | Anti-CTLA-4 Monoclonal Antibody
Item
received prior therapies: ibrutinib, or other btk inhibitor and/or anti-pd1, anti-pd-l1, anti-pd-l2, anti-cd137, or ctla-4 antibody
boolean
C3501358 (UMLS CUI [1])
C4086017 (UMLS CUI [2])
C4289970 (UMLS CUI [3])
C4289971 (UMLS CUI [4])
C1705357 (UMLS CUI [5,1])
C0003250 (UMLS CUI [5,2])
C1831875 (UMLS CUI [6])
C4289973 (UMLS CUI [7])
C4086017 (UMLS CUI [2])
C4289970 (UMLS CUI [3])
C4289971 (UMLS CUI [4])
C1705357 (UMLS CUI [5,1])
C0003250 (UMLS CUI [5,2])
C1831875 (UMLS CUI [6])
C4289973 (UMLS CUI [7])
Patient need for CYP3A Inhibitors | CYP3A Inhibitors Prophylactic treatment
Item
requires treatment or prophylaxis with a strong cytochrome p450 (cyp) 3a inhibitor
boolean
C0686904 (UMLS CUI [1,1])
C3850056 (UMLS CUI [1,2])
C3850056 (UMLS CUI [2,1])
C0199176 (UMLS CUI [2,2])
C3850056 (UMLS CUI [1,2])
C3850056 (UMLS CUI [2,1])
C0199176 (UMLS CUI [2,2])
Primary central nervous system lymphoma | Central Nervous System Involvement Lymphoma
Item
primary cns lymphoma or evidence of cns involvement by lymphoma
boolean
C0280803 (UMLS CUI [1])
C4050309 (UMLS CUI [2,1])
C0024299 (UMLS CUI [2,2])
C4050309 (UMLS CUI [2,1])
C0024299 (UMLS CUI [2,2])