ID

39051

Beschreibung

Ibrutinib and Lenalidomide With Dose Adjusted EPOCH-R in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT02142049

Link

https://clinicaltrials.gov/show/NCT02142049

Stichworte

Versionen (1)
  1. 24.11.19 24.11.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

24. November 2019

DOI

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Creative Commons BY 4.0
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Eligibility Diffuse Large B Cell Lymphoma Relapsed NCT02142049

Englisch

Eligibility Diffuse Large B Cell Lymphoma Relapsed NCT02142049

1 Formulare  
Criteria
Beschreibung

Criteria

eastern cooperative oncology group (ecog) performance status of ≤2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
pathologically confirmed relapsed/refractory dlbcl
Beschreibung

Diffuse large B-cell lymphoma recurrent | Diffuse large B-cell lymphoma refractory

Datentyp

boolean

Alias
UMLS CUI [1]
C0855111
UMLS CUI [2]
C0855112
subjects must have ≥1 measurable disease site on ct scan (≥ 1.5 cm in longest dimension).
Beschreibung

Measurable Disease Site Quantity CT scan | Measurable Disease Longest Diameter CT scan

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0040405
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0552406
UMLS CUI [2,3]
C0040405
adequate hepatic and renal function:
Beschreibung

Liver function | Renal function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
ast or alt ≤2.5 x uln
Beschreibung

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
serum creatinine ≤ 2.0 mg/dl or creatinine clearance ≥60 ml/min/1.73
Beschreibung

Creatinine measurement, serum | Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
bilirubin ≤1.5 x uln
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
adequate hematologic function:
Beschreibung

Hematologic function

Datentyp

boolean

Alias
UMLS CUI [1]
C0221130
anc >1,000 cells/mm3
Beschreibung

Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
platelets ≥75,000 cells/mm3
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
hemoglobin ≥8.0 g/dl
Beschreibung

Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
prothrombin time (pt) and activated partial thromboplastin time (aptt) must be
Beschreibung

Prothrombin time assay | Activated Partial Thromboplastin Time measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0033707
UMLS CUI [2]
C0030605
≤1.5 x the upper limit of the normal range (uln)
Beschreibung

ID.13

Datentyp

boolean

must be registered into the revlimid rems™program and be willing to comply with the requirements of revlimid rems™.
Beschreibung

Enrollment Revlimid Program Specified | Compliance behavior Revlimid Program Specified

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C1135145
UMLS CUI [1,3]
C3484370
UMLS CUI [1,4]
C0205369
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C1135145
UMLS CUI [2,3]
C3484370
UMLS CUI [2,4]
C0205369
major exclusion criteria:
Beschreibung

Exclusion Criteria Major

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205164
known central nervous system lymphoma
Beschreibung

Central nervous system lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0280803
any chemotherapy, external beam radiation therapy, or anti-cancer antibodies within 2 weeks
Beschreibung

Chemotherapy | External Beam Radiation Therapy | Antineoplastic Antibody

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1517033
UMLS CUI [3]
C4329348
radio- or toxin-immunoconjugates within 10 weeks
Beschreibung

Radioimmunoconjugates | Toxin Immunoconjugates

Datentyp

boolean

Alias
UMLS CUI [1]
C0243019
UMLS CUI [2,1]
C0040549
UMLS CUI [2,2]
C0243020
prior allogenetic stem cell (or other organ) transplant within 6 months or any evidence of active graft-versus-host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug
Beschreibung

Allogeneic Stem Cell Transplantation | Organ Transplant | Graft-vs-Host Disease | Requirement Immunosuppressive Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C2242529
UMLS CUI [2]
C0029216
UMLS CUI [3]
C0018133
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0021081
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Diffuse Large B Cell Lymphoma Relapsed NCT02142049

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of ≤2
boolean
C1520224 (UMLS CUI [1])
Diffuse large B-cell lymphoma recurrent | Diffuse large B-cell lymphoma refractory
Item
pathologically confirmed relapsed/refractory dlbcl
boolean
C0855111 (UMLS CUI [1])
C0855112 (UMLS CUI [2])
Measurable Disease Site Quantity CT scan | Measurable Disease Longest Diameter CT scan
Item
subjects must have ≥1 measurable disease site on ct scan (≥ 1.5 cm in longest dimension).
boolean
C1513041 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0040405 (UMLS CUI [1,4])
C1513041 (UMLS CUI [2,1])
C0552406 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
Liver function | Renal function
Item
adequate hepatic and renal function:
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast or alt ≤2.5 x uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum | Creatinine clearance measurement
Item
serum creatinine ≤ 2.0 mg/dl or creatinine clearance ≥60 ml/min/1.73
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Serum total bilirubin measurement
Item
bilirubin ≤1.5 x uln
boolean
C1278039 (UMLS CUI [1])
Hematologic function
Item
adequate hematologic function:
boolean
C0221130 (UMLS CUI [1])
Absolute neutrophil count
Item
anc >1,000 cells/mm3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets ≥75,000 cells/mm3
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin ≥8.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Prothrombin time assay | Activated Partial Thromboplastin Time measurement
Item
prothrombin time (pt) and activated partial thromboplastin time (aptt) must be
boolean
C0033707 (UMLS CUI [1])
C0030605 (UMLS CUI [2])
ID.13
Item
≤1.5 x the upper limit of the normal range (uln)
boolean
Enrollment Revlimid Program Specified | Compliance behavior Revlimid Program Specified
Item
must be registered into the revlimid rems™program and be willing to comply with the requirements of revlimid rems™.
boolean
C1516879 (UMLS CUI [1,1])
C1135145 (UMLS CUI [1,2])
C3484370 (UMLS CUI [1,3])
C0205369 (UMLS CUI [1,4])
C1321605 (UMLS CUI [2,1])
C1135145 (UMLS CUI [2,2])
C3484370 (UMLS CUI [2,3])
C0205369 (UMLS CUI [2,4])
Exclusion Criteria Major
Item
major exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Central nervous system lymphoma
Item
known central nervous system lymphoma
boolean
C0280803 (UMLS CUI [1])
Chemotherapy | External Beam Radiation Therapy | Antineoplastic Antibody
Item
any chemotherapy, external beam radiation therapy, or anti-cancer antibodies within 2 weeks
boolean
C0392920 (UMLS CUI [1])
C1517033 (UMLS CUI [2])
C4329348 (UMLS CUI [3])
Radioimmunoconjugates | Toxin Immunoconjugates
Item
radio- or toxin-immunoconjugates within 10 weeks
boolean
C0243019 (UMLS CUI [1])
C0040549 (UMLS CUI [2,1])
C0243020 (UMLS CUI [2,2])
Allogeneic Stem Cell Transplantation | Organ Transplant | Graft-vs-Host Disease | Requirement Immunosuppressive Agents
Item
prior allogenetic stem cell (or other organ) transplant within 6 months or any evidence of active graft-versus-host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug
boolean
C2242529 (UMLS CUI [1])
C0029216 (UMLS CUI [2])
C0018133 (UMLS CUI [3])
C1514873 (UMLS CUI [4,1])
C0021081 (UMLS CUI [4,2])
Zum Seitenanfang zurückkehren 

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