ID

37003

Beskrivning

Ibrutinib in Combination With Lenalidomide, With and Without Rituximab in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT02077166

Länk

https://clinicaltrials.gov/show/NCT02077166

Nyckelord

Versioner (1)
  1. 2019-06-27 2019-06-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

27 juni 2019

DOI

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Creative Commons BY 4.0
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Eligibility Relapsed Diffuse Large B-Cell Lymphoma NCT02077166

Engelsk

Eligibility Relapsed Diffuse Large B-Cell Lymphoma NCT02077166

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologically confirmed relapsed/ refractory dlbcl
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0855111
UMLS CUI [2]
C0855112
must have previously received first line treatment regimen
Beskrivning

First line treatment Previous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0205156
must be ineligible for high dose therapy/ stem cell transplantation
Beskrivning

Ineligibility Therapeutic procedure High dose | Ineligibility Stem cell transplant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512714
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0444956
UMLS CUI [2,1]
C1512714
UMLS CUI [2,2]
C1504389
measurable disease sites on ct scan (>1.5 cm in longest dimension)
Beskrivning

Measurable Disease Site CT scan | Measurable Disease Longest Diameter

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0040405
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0552406
pt/inr <1.5 x uln and ptt (aptt) <1.5 x uln
Beskrivning

Prothrombin time assay | International Normalized Ratio | Activated Partial Thromboplastin Time measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0033707
UMLS CUI [2]
C0525032
UMLS CUI [3]
C0030605
men and women ≥18 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog < 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate hepatic and renal function:
Beskrivning

Liver function | Renal function

Datatyp

boolean

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

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
2. creatinine clearance (cockcroft-gault or 24-hour creatinine clearance collection) >60 ml/min.
Beskrivning

Estimation of creatinine clearance by Cockcroft-Gault formula | 24 hour renal creatinine clearance

Datatyp

boolean

Alias
UMLS CUI [1]
C2711451
UMLS CUI [2]
C4032392
adequate hematologic function:
Beskrivning

Hematologic function

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
1. anc >1.50 cells/mm3
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
2. plt >75,000 cells/mm3
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
3. hgb >8.0 g/dl
Beskrivning

Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
medically apparent central nervous system lymphoma or leptomeningeal disease
Beskrivning

Central nervous system lymphoma | Leptomeningeal disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0280803
UMLS CUI [2]
C0751297
history of allogeneic stem-cell (or other organ) transplantation
Beskrivning

Allogeneic Stem Cell Transplantation | Organ Transplantation

Datatyp

boolean

Alias
UMLS CUI [1]
C2242529
UMLS CUI [2]
C0029216
any chemotherapy, external beam radiation therapy, or anticancer antibodies within 2 weeks
Beskrivning

Chemotherapy | External Beam Radiation Therapy | Antineoplastic Antibody

Datatyp

boolean

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

Radioimmunoconjugates | Toxin Immunoconjugates

Datatyp

boolean

Alias
UMLS CUI [1]
C0243019
UMLS CUI [2,1]
C0040549
UMLS CUI [2,2]
C0243020
concurrent enrollment in another therapeutic investigational study or have previously taken ibrutinib and/or lenalidomide.
Beskrivning

Study Subject Participation Status | Therapies, Investigational | Ibrutinib | lenalidomide

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0949266
UMLS CUI [3]
C3501358
UMLS CUI [4]
C1144149
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Similar models

Eligibility Relapsed Diffuse Large B-Cell Lymphoma NCT02077166

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
First line treatment Previous
Item
must have previously received first line treatment regimen
boolean
C1708063 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Ineligibility Therapeutic procedure High dose | Ineligibility Stem cell transplant
Item
must be ineligible for high dose therapy/ stem cell transplantation
boolean
C1512714 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0444956 (UMLS CUI [1,3])
C1512714 (UMLS CUI [2,1])
C1504389 (UMLS CUI [2,2])
Measurable Disease Site CT scan | Measurable Disease Longest Diameter
Item
measurable disease sites on ct scan (>1.5 cm in longest dimension)
boolean
C1513041 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C0552406 (UMLS CUI [2,2])
Prothrombin time assay | International Normalized Ratio | Activated Partial Thromboplastin Time measurement
Item
pt/inr <1.5 x uln and ptt (aptt) <1.5 x uln
boolean
C0033707 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
C0030605 (UMLS CUI [3])
Age
Item
men and women ≥18 years of age
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog < 2
boolean
C1520224 (UMLS CUI [1])
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
1. ast or alt ≤2.5 x uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Estimation of creatinine clearance by Cockcroft-Gault formula | 24 hour renal creatinine clearance
Item
2. creatinine clearance (cockcroft-gault or 24-hour creatinine clearance collection) >60 ml/min.
boolean
C2711451 (UMLS CUI [1])
C4032392 (UMLS CUI [2])
Hematologic function
Item
adequate hematologic function:
boolean
C0221130 (UMLS CUI [1])
Absolute neutrophil count
Item
1. anc >1.50 cells/mm3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
2. plt >75,000 cells/mm3
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
3. hgb >8.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Central nervous system lymphoma | Leptomeningeal disease
Item
medically apparent central nervous system lymphoma or leptomeningeal disease
boolean
C0280803 (UMLS CUI [1])
C0751297 (UMLS CUI [2])
Allogeneic Stem Cell Transplantation | Organ Transplantation
Item
history of allogeneic stem-cell (or other organ) transplantation
boolean
C2242529 (UMLS CUI [1])
C0029216 (UMLS CUI [2])
Chemotherapy | External Beam Radiation Therapy | Antineoplastic Antibody
Item
any chemotherapy, external beam radiation therapy, or anticancer 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])
Study Subject Participation Status | Therapies, Investigational | Ibrutinib | lenalidomide
Item
concurrent enrollment in another therapeutic investigational study or have previously taken ibrutinib and/or lenalidomide.
boolean
C2348568 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
C3501358 (UMLS CUI [3])
C1144149 (UMLS CUI [4])
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