ID

39094

Description

Safety and Efficacy Study of Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01325701

Link

https://clinicaltrials.gov/show/NCT01325701

Keywords

Versions (1)
  1. 12/1/19 12/1/19 -
Copyright Holder

See clinicaltrials.gov

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December 1, 2019

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License

Creative Commons BY 4.0
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Eligibility Diffuse Large Cell B-lymphoma NCT01325701

English

Eligibility Diffuse Large Cell B-lymphoma NCT01325701

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. men and women ≥ 18 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. ecog performance status ≤ 2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
3. pathologically confirmed de novo dlbcl
Description

Diffuse Large B-Cell Lymphoma de novo

Data type

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C1515568
4. subjects must have available tissue for central pathology review to be eligible. treatment group 2: subjects will be eligible if they have the non-gcb phenotype, as confirmed by central ihc testing by the hans method.
Description

Availability of Tissue | Phenotype Except Germinal Center B-Cell Type | Immunohistochemistry

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0040300
UMLS CUI [2,1]
C0031437
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C1333295
UMLS CUI [3]
C0021044
5. relapsed or refractory disease, defined as either: 1) recurrence of disease after a cr, or 2) pr, sd, or progressive disease (pd) at completion of the treatment regimen preceding entry to the study (residual disease): subjects must have previously received an appropriate first-line treatment regimen. subjects who have not received hdt/asct must be ineligible for hdt/asct
Description

Recurrent disease | Refractory Disease | Recurrence Post Complete remission | Partial response | Stable Disease | Progressive Disease | Treatment regimen Completion | Residual disease | Status post First line treatment | High-Dose Chemotherapy with Autologous Stem Cell Transplant

Data type

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C1514815
UMLS CUI [3,1]
C0034897
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C0677874
UMLS CUI [4]
C1521726
UMLS CUI [5]
C0677946
UMLS CUI [6]
C1335499
UMLS CUI [7,1]
C0040808
UMLS CUI [7,2]
C0205197
UMLS CUI [8]
C0543478
UMLS CUI [9,1]
C0231290
UMLS CUI [9,2]
C1708063
UMLS CUI [10]
C1512429
6. treatment group 1: subjects must have ≥ 1 measurable (> 2 cm in longest dimension) disease sites on ct scan. treatment group 2: subjects must have ≥ 1 measurable (> 1.5 cm in longest dimension) disease sites on ct scan.
Description

Measurable Disease Site Quantity CT scan | Measurable Disease Longest Diameter

Data type

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
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. transformed dlbcl or dlbcl with coexistent histologies (eg, fl or malt).
Description

Diffuse Large B-Cell Lymphoma Transformed | Diffuse Large B-Cell Lymphoma with Follicular Lymphoma | Diffuse Large B-Cell Lymphoma with MALT Lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C0457344
UMLS CUI [2,1]
C0079744
UMLS CUI [2,2]
C0332287
UMLS CUI [2,3]
C0024301
UMLS CUI [3,1]
C0079744
UMLS CUI [3,2]
C0332287
UMLS CUI [3,3]
C0242647
2. primary mediastinal (thymic) large b-cell lymphoma.
Description

Mediastinal (Thymic) Large B-Cell Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C1292754
3. known central nervous system lymphoma. in addition, for subjects in treatment group 2, known leptomeningeal involvement is exclusionary.
Description

Primary central nervous system lymphoma | Involvement Leptomeningeal

Data type

boolean

Alias
UMLS CUI [1]
C0280803
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0521401
4. certain exclusions on prior therapy
Description

Exclusion Due to Prior Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
5. major surgery within 2 weeks of first dose of study drug.
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
6. any of the following laboratory abnormalities:
Description

LABORATORY ABNORMALITIES

Data type

boolean

Alias
UMLS CUI [1]
C1853129
1. anc < 0.75 x 10^9/l. treatment group 2: eligible subjects must be independent of growth factor support for 7 days prior to the screening lab tests.
Description

Absolute neutrophil count | Eligibility Independent of Growth Factor Support

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2,1]
C1548635
UMLS CUI [2,2]
C0332291
UMLS CUI [2,3]
C0018284
UMLS CUI [2,4]
C1521721
2. platelet count < 50 x 10^9/l independent of transfusion support. treatment group 2 only: eligible subjects must be independent of transfusion support for 7 days prior to the screening lab tests.
Description

Platelet Count measurement | Independent of Transfusion Support | Eligibility Independent of Transfusion Support

Data type

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2,1]
C0332291
UMLS CUI [2,2]
C1879316
UMLS CUI [2,3]
C1521721
UMLS CUI [3,1]
C1548635
UMLS CUI [3,2]
C0332291
UMLS CUI [3,3]
C1879316
UMLS CUI [3,4]
C1521721
3. ast or alt ≥ 3.0 x upper limit of normal (uln)
Description

Aspartate aminotransferase increased | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
4. creatinine > 2.0 x uln
Description

Serum creatinine raised

Data type

boolean

Alias
UMLS CUI [1]
C0700225
5. treatment group 2 only: hemoglobin < 8.0 g/dl
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
6. treatment group 2 only: total bilirubin > 1.5 x uln
Description

Elevated total bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0741494
7. requires or has received anticoagulation treatment with warfarin or equivalent vitamin k antagonists (eg, phenprocoumon)
Description

Requirement Anticoagulation Therapy | Anticoagulation Therapy | Warfarin therapy | Treatment with Vitamin K antagonist | Phenprocoumon

Data type

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0003281
UMLS CUI [2]
C0003281
UMLS CUI [3]
C4303340
UMLS CUI [4]
C1096489
UMLS CUI [5]
C0031444
8. treatment group 2: requires treatment with a strong cytochrome p450 (cyp) 3a4/5 inhibitor
Description

Requirement CYP3A4 Inhibitor Strong | Requirement CYP3A5 Inhibitors Strong

Data type

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C3830624
UMLS CUI [1,3]
C0442821
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C3850054
UMLS CUI [2,3]
C0442821
9. treatment group 2: known bleeding diathesis, eg, von willebrand's disease, hemophilia.
Description

Bleeding tendency | von Willebrand Disease | Hemophilia

Data type

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0042974
UMLS CUI [3]
C0684275
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Similar models

Eligibility Diffuse Large Cell B-lymphoma NCT01325701

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. men and women ≥ 18 years of age.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
2. ecog performance status ≤ 2.
boolean
C1520224 (UMLS CUI [1])
Diffuse Large B-Cell Lymphoma de novo
Item
3. pathologically confirmed de novo dlbcl
boolean
C0079744 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
Availability of Tissue | Phenotype Except Germinal Center B-Cell Type | Immunohistochemistry
Item
4. subjects must have available tissue for central pathology review to be eligible. treatment group 2: subjects will be eligible if they have the non-gcb phenotype, as confirmed by central ihc testing by the hans method.
boolean
C0470187 (UMLS CUI [1,1])
C0040300 (UMLS CUI [1,2])
C0031437 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C1333295 (UMLS CUI [2,3])
C0021044 (UMLS CUI [3])
Recurrent disease | Refractory Disease | Recurrence Post Complete remission | Partial response | Stable Disease | Progressive Disease | Treatment regimen Completion | Residual disease | Status post First line treatment | High-Dose Chemotherapy with Autologous Stem Cell Transplant
Item
5. relapsed or refractory disease, defined as either: 1) recurrence of disease after a cr, or 2) pr, sd, or progressive disease (pd) at completion of the treatment regimen preceding entry to the study (residual disease): subjects must have previously received an appropriate first-line treatment regimen. subjects who have not received hdt/asct must be ineligible for hdt/asct
boolean
C0277556 (UMLS CUI [1])
C1514815 (UMLS CUI [2])
C0034897 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C0677874 (UMLS CUI [3,3])
C1521726 (UMLS CUI [4])
C0677946 (UMLS CUI [5])
C1335499 (UMLS CUI [6])
C0040808 (UMLS CUI [7,1])
C0205197 (UMLS CUI [7,2])
C0543478 (UMLS CUI [8])
C0231290 (UMLS CUI [9,1])
C1708063 (UMLS CUI [9,2])
C1512429 (UMLS CUI [10])
Measurable Disease Site Quantity CT scan | Measurable Disease Longest Diameter
Item
6. treatment group 1: subjects must have ≥ 1 measurable (> 2 cm in longest dimension) disease sites on ct scan. treatment group 2: subjects must have ≥ 1 measurable (> 1.5 cm in longest dimension) disease sites on ct scan.
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])
Item Group
C0680251 (UMLS CUI)
Diffuse Large B-Cell Lymphoma Transformed | Diffuse Large B-Cell Lymphoma with Follicular Lymphoma | Diffuse Large B-Cell Lymphoma with MALT Lymphoma
Item
1. transformed dlbcl or dlbcl with coexistent histologies (eg, fl or malt).
boolean
C0079744 (UMLS CUI [1,1])
C0457344 (UMLS CUI [1,2])
C0079744 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C0024301 (UMLS CUI [2,3])
C0079744 (UMLS CUI [3,1])
C0332287 (UMLS CUI [3,2])
C0242647 (UMLS CUI [3,3])
Mediastinal (Thymic) Large B-Cell Lymphoma
Item
2. primary mediastinal (thymic) large b-cell lymphoma.
boolean
C1292754 (UMLS CUI [1])
Primary central nervous system lymphoma | Involvement Leptomeningeal
Item
3. known central nervous system lymphoma. in addition, for subjects in treatment group 2, known leptomeningeal involvement is exclusionary.
boolean
C0280803 (UMLS CUI [1])
C1314939 (UMLS CUI [2,1])
C0521401 (UMLS CUI [2,2])
Exclusion Due to Prior Therapy
Item
4. certain exclusions on prior therapy
boolean
C2828389 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
Major surgery
Item
5. major surgery within 2 weeks of first dose of study drug.
boolean
C0679637 (UMLS CUI [1])
LABORATORY ABNORMALITIES
Item
6. any of the following laboratory abnormalities:
boolean
C1853129 (UMLS CUI [1])
Absolute neutrophil count | Eligibility Independent of Growth Factor Support
Item
1. anc < 0.75 x 10^9/l. treatment group 2: eligible subjects must be independent of growth factor support for 7 days prior to the screening lab tests.
boolean
C0948762 (UMLS CUI [1])
C1548635 (UMLS CUI [2,1])
C0332291 (UMLS CUI [2,2])
C0018284 (UMLS CUI [2,3])
C1521721 (UMLS CUI [2,4])
Platelet Count measurement | Independent of Transfusion Support | Eligibility Independent of Transfusion Support
Item
2. platelet count < 50 x 10^9/l independent of transfusion support. treatment group 2 only: eligible subjects must be independent of transfusion support for 7 days prior to the screening lab tests.
boolean
C0032181 (UMLS CUI [1])
C0332291 (UMLS CUI [2,1])
C1879316 (UMLS CUI [2,2])
C1521721 (UMLS CUI [2,3])
C1548635 (UMLS CUI [3,1])
C0332291 (UMLS CUI [3,2])
C1879316 (UMLS CUI [3,3])
C1521721 (UMLS CUI [3,4])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
3. ast or alt ≥ 3.0 x upper limit of normal (uln)
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Serum creatinine raised
Item
4. creatinine > 2.0 x uln
boolean
C0700225 (UMLS CUI [1])
Hemoglobin measurement
Item
5. treatment group 2 only: hemoglobin < 8.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Elevated total bilirubin
Item
6. treatment group 2 only: total bilirubin > 1.5 x uln
boolean
C0741494 (UMLS CUI [1])
Requirement Anticoagulation Therapy | Anticoagulation Therapy | Warfarin therapy | Treatment with Vitamin K antagonist | Phenprocoumon
Item
7. requires or has received anticoagulation treatment with warfarin or equivalent vitamin k antagonists (eg, phenprocoumon)
boolean
C1514873 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
C0003281 (UMLS CUI [2])
C4303340 (UMLS CUI [3])
C1096489 (UMLS CUI [4])
C0031444 (UMLS CUI [5])
Requirement CYP3A4 Inhibitor Strong | Requirement CYP3A5 Inhibitors Strong
Item
8. treatment group 2: requires treatment with a strong cytochrome p450 (cyp) 3a4/5 inhibitor
boolean
C1514873 (UMLS CUI [1,1])
C3830624 (UMLS CUI [1,2])
C0442821 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C3850054 (UMLS CUI [2,2])
C0442821 (UMLS CUI [2,3])
Bleeding tendency | von Willebrand Disease | Hemophilia
Item
9. treatment group 2: known bleeding diathesis, eg, von willebrand's disease, hemophilia.
boolean
C1458140 (UMLS CUI [1])
C0042974 (UMLS CUI [2])
C0684275 (UMLS CUI [3])
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