ID

36288

Description

A Study of PCI-32765 (Ibrutinib) in Combination With Either Bendamustine and Rituximab or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Participants With Previously Treated Indolent Non-Hodgkin Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01974440

Link

https://clinicaltrials.gov/show/NCT01974440

Keywords

Versions (1)
  1. 4/30/19 4/30/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 30, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Lymphoma NCT01974440

English

Eligibility Lymphoma NCT01974440

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT01974440
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed diagnosis of b-cell indolent non-hodgkin lymphoma with histological subtype limited to follicular lymphoma or marginal zone lymphoma, at initial diagnosis and without evidence of pathological transformation or clinical signs suggesting transformation
Description

B-Cell Lymphoma indolent | Lymphoma, Follicular | Marginal Zone B-Cell Lymphoma | Transformation Absent | Signs Transformation Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0079731
UMLS CUI [1,2]
C0234227
UMLS CUI [2]
C0024301
UMLS CUI [3]
C1367654
UMLS CUI [4,1]
C0040682
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0311392
UMLS CUI [5,2]
C0040682
UMLS CUI [5,3]
C0332197
at least 1 prior treatment with a cd20 antibody combination chemo-immunotherapy regimen
Description

Prior Therapy Quantity | Chemoimmunotherapy Anti-CD20 Antibody

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C2986423
UMLS CUI [2,2]
C3891557
disease that has relapsed or was refractory after prior chemo-immunotherapy
Description

Recurrent disease | Refractory Disease | Status post Chemoimmunotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C1514815
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C2986423
at least 1 measurable site of disease according to revised response criteria for malignant lymphoma 2007
Description

Measurable Disease Site Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C1265611
eastern cooperative oncology group performance status grade 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
laboratory values within protocol-defined parameters
Description

Laboratory Results Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C2348563
agrees to protocol-defined use of effective contraception
Description

Contraceptive methods Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C2348563
men must agree not to donate sperm during and after the study for 6 months after the last dose of bendamustine, 12 months after the last dose of rituximab, or 3 months after the last dose of study medication, whichever is later
Description

Gender Sperm donation Absent | bendamustine | rituximab | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0871414
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0525079
UMLS CUI [3]
C0393022
UMLS CUI [4]
C0013230
women of childbearing potential must have a negative serum or urine pregnancy test at screening
Description

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430057
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment according to protocol-defined criteria
Description

Prior Therapy Study Protocol Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0243161
unable to receive background chemotherapy based on prior treatment history and cardiac function
Description

Background Chemotherapy Unable | Etiology Prior Therapy | Etiology Cardiac function

Data type

boolean

Alias
UMLS CUI [1,1]
C1706907
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C1514463
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0232164
known central nervous system lymphoma
Description

Central nervous system lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0742472
diagnosed or treated for malignancy other than indolent non-hodgkin lymphoma
Description

Malignant Neoplasms | Cancer treatment | Exception Non-Hodgkin Lymphoma indolent

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0920425
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0024305
UMLS CUI [3,3]
C0234227
history of stroke or intracranial hemorrhage within 6 months prior to randomization
Description

Cerebrovascular accident | Intracranial Hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0151699
requires anticoagulation with warfarin or equivalent vitamin k antagonists
Description

Anticoagulation Therapy | Warfarin | Vitamin K Antagonist Equivalent

Data type

boolean

Alias
UMLS CUI [1]
C0003281
UMLS CUI [2]
C0043031
UMLS CUI [3,1]
C2267235
UMLS CUI [3,2]
C0205163
requires treatment with strong cyp3a inhibitors
Description

CYP3A Inhibitors Strong

Data type

boolean

Alias
UMLS CUI [1,1]
C3850056
UMLS CUI [1,2]
C0442821
clinically significant cardiovascular disease
Description

Cardiovascular Disease

Data type

boolean

Alias
UMLS CUI [1]
C0007222
known history of human immunodeficiency virus or active hepatitis c virus (hcv; ribonucleic acid [rna] polymerase chain reaction [pcr]-positive) or active hepatitis b virus (hbv; dna pcr-positive) infection or any uncontrolled active systemic infection requiring intravenous antibiotics
Description

HIV Infection | Hepatitis C | Hepatitis C virus RNA Polymerase chain reaction positive | Hepatitis B | Hepatitis B virus DNA Polymerase chain reaction positive | Sepsis Uncontrolled | Requirement Antibiotics Intravenous

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019196
UMLS CUI [3,1]
C0369335
UMLS CUI [3,2]
C3888499
UMLS CUI [4]
C0019163
UMLS CUI [5,1]
C0369332
UMLS CUI [5,2]
C3888499
UMLS CUI [6,1]
C0243026
UMLS CUI [6,2]
C0205318
UMLS CUI [7,1]
C1514873
UMLS CUI [7,2]
C0003232
UMLS CUI [7,3]
C1522726
any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
Description

Life threatening illness compromises Patient safety | Medical condition compromises Patient safety | Organ system Dysfunction compromises Patient safety | Life threatening illness Interferes with Absorption Ibrutinib Capsule | Medical condition Interferes with Absorption Ibrutinib Capsule | Organ system Dysfunction Interferes with Absorption Ibrutinib Capsule | Life threatening illness Interferes with Metabolism Ibrutinib Capsule | Medical condition Interferes with Metabolism Ibrutinib Capsule | Organ system Dysfunction Interferes with Metabolism Ibrutinib Capsule | Life threatening illness Research results At risk | Medical condition Research results At risk | Organ system Dysfunction Research results At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C3846017
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C1113679
UMLS CUI [3,1]
C0460002
UMLS CUI [3,2]
C3887504
UMLS CUI [3,3]
C2945640
UMLS CUI [3,4]
C1113679
UMLS CUI [4,1]
C3846017
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0237442
UMLS CUI [4,4]
C3692991
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0237442
UMLS CUI [5,4]
C3692991
UMLS CUI [6,1]
C0460002
UMLS CUI [6,2]
C3887504
UMLS CUI [6,3]
C0521102
UMLS CUI [6,4]
C0237442
UMLS CUI [6,5]
C3692991
UMLS CUI [7,1]
C3846017
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C0025519
UMLS CUI [7,4]
C3692991
UMLS CUI [8,1]
C3843040
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C0025519
UMLS CUI [8,4]
C3692991
UMLS CUI [9,1]
C0460002
UMLS CUI [9,2]
C3887504
UMLS CUI [9,3]
C0521102
UMLS CUI [9,4]
C0025519
UMLS CUI [9,5]
C3692991
UMLS CUI [10,1]
C3846017
UMLS CUI [10,2]
C0683954
UMLS CUI [10,3]
C1444641
UMLS CUI [11,1]
C3843040
UMLS CUI [11,2]
C0683954
UMLS CUI [11,3]
C1444641
UMLS CUI [12,1]
C0460002
UMLS CUI [12,2]
C3887504
UMLS CUI [12,3]
C0683954
UMLS CUI [12,4]
C1444641
women who are pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Lymphoma NCT01974440

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT01974440
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
B-Cell Lymphoma indolent | Lymphoma, Follicular | Marginal Zone B-Cell Lymphoma | Transformation Absent | Signs Transformation Absent
Item
histologically confirmed diagnosis of b-cell indolent non-hodgkin lymphoma with histological subtype limited to follicular lymphoma or marginal zone lymphoma, at initial diagnosis and without evidence of pathological transformation or clinical signs suggesting transformation
boolean
C0079731 (UMLS CUI [1,1])
C0234227 (UMLS CUI [1,2])
C0024301 (UMLS CUI [2])
C1367654 (UMLS CUI [3])
C0040682 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0311392 (UMLS CUI [5,1])
C0040682 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Prior Therapy Quantity | Chemoimmunotherapy Anti-CD20 Antibody
Item
at least 1 prior treatment with a cd20 antibody combination chemo-immunotherapy regimen
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2986423 (UMLS CUI [2,1])
C3891557 (UMLS CUI [2,2])
Recurrent disease | Refractory Disease | Status post Chemoimmunotherapy
Item
disease that has relapsed or was refractory after prior chemo-immunotherapy
boolean
C0277556 (UMLS CUI [1])
C1514815 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C2986423 (UMLS CUI [3,2])
Measurable Disease Site Quantity
Item
at least 1 measurable site of disease according to revised response criteria for malignant lymphoma 2007
boolean
C1513041 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
ECOG performance status
Item
eastern cooperative oncology group performance status grade 0 or 1
boolean
C1520224 (UMLS CUI [1])
Laboratory Results Study Protocol
Item
laboratory values within protocol-defined parameters
boolean
C1254595 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Contraceptive methods Study Protocol
Item
agrees to protocol-defined use of effective contraception
boolean
C0700589 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Gender Sperm donation Absent | bendamustine | rituximab | Investigational New Drugs
Item
men must agree not to donate sperm during and after the study for 6 months after the last dose of bendamustine, 12 months after the last dose of rituximab, or 3 months after the last dose of study medication, whichever is later
boolean
C0079399 (UMLS CUI [1,1])
C0871414 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0525079 (UMLS CUI [2])
C0393022 (UMLS CUI [3])
C0013230 (UMLS CUI [4])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
women of childbearing potential must have a negative serum or urine pregnancy test at screening
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Study Protocol Criteria
Item
prior treatment according to protocol-defined criteria
boolean
C1514463 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
Background Chemotherapy Unable | Etiology Prior Therapy | Etiology Cardiac function
Item
unable to receive background chemotherapy based on prior treatment history and cardiac function
boolean
C1706907 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0232164 (UMLS CUI [3,2])
Central nervous system lymphoma
Item
known central nervous system lymphoma
boolean
C0742472 (UMLS CUI [1])
Malignant Neoplasms | Cancer treatment | Exception Non-Hodgkin Lymphoma indolent
Item
diagnosed or treated for malignancy other than indolent non-hodgkin lymphoma
boolean
C0006826 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0024305 (UMLS CUI [3,2])
C0234227 (UMLS CUI [3,3])
Cerebrovascular accident | Intracranial Hemorrhage
Item
history of stroke or intracranial hemorrhage within 6 months prior to randomization
boolean
C0038454 (UMLS CUI [1])
C0151699 (UMLS CUI [2])
Anticoagulation Therapy | Warfarin | Vitamin K Antagonist Equivalent
Item
requires anticoagulation with warfarin or equivalent vitamin k antagonists
boolean
C0003281 (UMLS CUI [1])
C0043031 (UMLS CUI [2])
C2267235 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
CYP3A Inhibitors Strong
Item
requires treatment with strong cyp3a inhibitors
boolean
C3850056 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
Cardiovascular Disease
Item
clinically significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
HIV Infection | Hepatitis C | Hepatitis C virus RNA Polymerase chain reaction positive | Hepatitis B | Hepatitis B virus DNA Polymerase chain reaction positive | Sepsis Uncontrolled | Requirement Antibiotics Intravenous
Item
known history of human immunodeficiency virus or active hepatitis c virus (hcv; ribonucleic acid [rna] polymerase chain reaction [pcr]-positive) or active hepatitis b virus (hbv; dna pcr-positive) infection or any uncontrolled active systemic infection requiring intravenous antibiotics
boolean
C0019693 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0369335 (UMLS CUI [3,1])
C3888499 (UMLS CUI [3,2])
C0019163 (UMLS CUI [4])
C0369332 (UMLS CUI [5,1])
C3888499 (UMLS CUI [5,2])
C0243026 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C1514873 (UMLS CUI [7,1])
C0003232 (UMLS CUI [7,2])
C1522726 (UMLS CUI [7,3])
Life threatening illness compromises Patient safety | Medical condition compromises Patient safety | Organ system Dysfunction compromises Patient safety | Life threatening illness Interferes with Absorption Ibrutinib Capsule | Medical condition Interferes with Absorption Ibrutinib Capsule | Organ system Dysfunction Interferes with Absorption Ibrutinib Capsule | Life threatening illness Interferes with Metabolism Ibrutinib Capsule | Medical condition Interferes with Metabolism Ibrutinib Capsule | Organ system Dysfunction Interferes with Metabolism Ibrutinib Capsule | Life threatening illness Research results At risk | Medical condition Research results At risk | Organ system Dysfunction Research results At risk
Item
any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
boolean
C3846017 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0460002 (UMLS CUI [3,1])
C3887504 (UMLS CUI [3,2])
C2945640 (UMLS CUI [3,3])
C1113679 (UMLS CUI [3,4])
C3846017 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0237442 (UMLS CUI [4,3])
C3692991 (UMLS CUI [4,4])
C3843040 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0237442 (UMLS CUI [5,3])
C3692991 (UMLS CUI [5,4])
C0460002 (UMLS CUI [6,1])
C3887504 (UMLS CUI [6,2])
C0521102 (UMLS CUI [6,3])
C0237442 (UMLS CUI [6,4])
C3692991 (UMLS CUI [6,5])
C3846017 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0025519 (UMLS CUI [7,3])
C3692991 (UMLS CUI [7,4])
C3843040 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C0025519 (UMLS CUI [8,3])
C3692991 (UMLS CUI [8,4])
C0460002 (UMLS CUI [9,1])
C3887504 (UMLS CUI [9,2])
C0521102 (UMLS CUI [9,3])
C0025519 (UMLS CUI [9,4])
C3692991 (UMLS CUI [9,5])
C3846017 (UMLS CUI [10,1])
C0683954 (UMLS CUI [10,2])
C1444641 (UMLS CUI [10,3])
C3843040 (UMLS CUI [11,1])
C0683954 (UMLS CUI [11,2])
C1444641 (UMLS CUI [11,3])
C0460002 (UMLS CUI [12,1])
C3887504 (UMLS CUI [12,2])
C0683954 (UMLS CUI [12,3])
C1444641 (UMLS CUI [12,4])
Pregnancy | Breast Feeding
Item
women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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