ID

39591

Description

Study of HCD122 (Lucatumumab) and Bendamustine Combination Therapy in CD40+ Rituximab-refractory Follicular Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01275209

Link

https://clinicaltrials.gov/show/NCT01275209

Keywords

Versions (1)
  1. 2/1/20 2/1/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 1, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Follicular Lymphoma NCT01275209

English

Eligibility Follicular Lymphoma NCT01275209

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed diagnosis of follicular lymphoma, according to the revised european american lymphoma/world health organization [real/who] classification
Description

Lymphoma, Follicular

Data type

boolean

Alias
UMLS CUI [1]
C0024301
documented cd40+ follicular lymphoma
Description

Follicular Lymphoma CD40 Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0054959
UMLS CUI [1,3]
C1514241
measurable lesion
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
refractory to rituximab
Description

Unresponsive to Rituximab

Data type

boolean

Alias
UMLS CUI [1,1]
C0205269
UMLS CUI [1,2]
C0393022
prior treatment with at least 1 chemotherapeutic regimen
Description

Chemotherapy Regimen Quantity Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0205156
18 years or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
who performance status grade 0, 1, or 2
Description

WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1]
C1298650
life expectancy > 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
obtained written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
grade 3b follicular lymphoma or evidence that the indolent lymphoma has transformed to aggressive lymphoma (i.e. dlbcl)
Description

Follicular Lymphoma Ann Arbor lymphoma staging system | Transformation Aggressive Lymphoma | Transformation Diffuse Large B-Cell Lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0432516
UMLS CUI [2,1]
C3714584
UMLS CUI [2,2]
C1332225
UMLS CUI [3,1]
C3714584
UMLS CUI [3,2]
C0079744
history of another primary malignancy that is currently clinically significant or currently requires active intervention
Description

Cancer Other Clinical Significance | Cancer Other Requirement Intervention

Data type

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C1707251
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0184661
prior allogeneic stem cell transplantation
Description

Allogeneic Stem Cell Transplantation Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C2242529
UMLS CUI [1,2]
C0205156
prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration
Description

Infusion related reaction Anaphylaxis | Infusion related reaction Severe | Intolerance Administration Immune Globulin (Human) | Intolerance Administration Monoclonal Antibodies

Data type

boolean

Alias
UMLS CUI [1,1]
C0948715
UMLS CUI [1,2]
C0002792
UMLS CUI [2,1]
C0948715
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0231199
UMLS CUI [3,2]
C1533734
UMLS CUI [3,3]
C0358321
UMLS CUI [4,1]
C0231199
UMLS CUI [4,2]
C1533734
UMLS CUI [4,3]
C0003250
impaired cardiac function or clinically significant cardiac disease
Description

Decreased cardiac function | Heart Disease Clinical Significance

Data type

boolean

Alias
UMLS CUI [1]
C0232166
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C2826293
history of acute or chronic pancreatitis, surgery of the pancreas, or any risk factors that may increase the risk of pancreatitis
Description

Pancreatitis | Pancreatitis, Chronic | Operation on pancreas | Risk factors Pancreatitis

Data type

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0149521
UMLS CUI [3]
C0193594
UMLS CUI [4,1]
C0035648
UMLS CUI [4,2]
C0030305
history of an active infection (viral, bacterial, or fungal) requiring systemic therapy within 28 days before study treatment.
Description

Communicable Disease Requirement Systemic therapy | Virus Diseases | Bacterial Infections | Mycoses

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1515119
UMLS CUI [2]
C0042769
UMLS CUI [3]
C0004623
UMLS CUI [4]
C0026946
known diagnosis of human immunodeficiency virus (hiv) infection
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
evidence of previous hepatitis viral infection such as hepatitis b or hepatitis c
Description

Viral hepatitis Previous | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0042721
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
ongoing corticosteroid use (>10 mg/day prednisone or equivalent)
Description

Adrenal Cortex Hormones | Prednisone U/day | Equivalent

Data type

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2,1]
C0032952
UMLS CUI [2,2]
C0456683
UMLS CUI [3]
C0205163
pregnant or nursing (lactating) women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
other protocol-defined inclusion/exclusion criteria may apply
Description

Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Follicular Lymphoma NCT01275209

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Lymphoma, Follicular
Item
confirmed diagnosis of follicular lymphoma, according to the revised european american lymphoma/world health organization [real/who] classification
boolean
C0024301 (UMLS CUI [1])
Follicular Lymphoma CD40 Positive
Item
documented cd40+ follicular lymphoma
boolean
C0024301 (UMLS CUI [1,1])
C0054959 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
Measurable Disease
Item
measurable lesion
boolean
C1513041 (UMLS CUI [1])
Unresponsive to Rituximab
Item
refractory to rituximab
boolean
C0205269 (UMLS CUI [1,1])
C0393022 (UMLS CUI [1,2])
Chemotherapy Regimen Quantity Previous
Item
prior treatment with at least 1 chemotherapeutic regimen
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Age
Item
18 years or older
boolean
C0001779 (UMLS CUI [1])
WHO performance status scale
Item
who performance status grade 0, 1, or 2
boolean
C1298650 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
obtained written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Follicular Lymphoma Ann Arbor lymphoma staging system | Transformation Aggressive Lymphoma | Transformation Diffuse Large B-Cell Lymphoma
Item
grade 3b follicular lymphoma or evidence that the indolent lymphoma has transformed to aggressive lymphoma (i.e. dlbcl)
boolean
C0024301 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
C3714584 (UMLS CUI [2,1])
C1332225 (UMLS CUI [2,2])
C3714584 (UMLS CUI [3,1])
C0079744 (UMLS CUI [3,2])
Cancer Other Clinical Significance | Cancer Other Requirement Intervention
Item
history of another primary malignancy that is currently clinically significant or currently requires active intervention
boolean
C1707251 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1707251 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0184661 (UMLS CUI [2,3])
Allogeneic Stem Cell Transplantation Previous
Item
prior allogeneic stem cell transplantation
boolean
C2242529 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Infusion related reaction Anaphylaxis | Infusion related reaction Severe | Intolerance Administration Immune Globulin (Human) | Intolerance Administration Monoclonal Antibodies
Item
prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration
boolean
C0948715 (UMLS CUI [1,1])
C0002792 (UMLS CUI [1,2])
C0948715 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0231199 (UMLS CUI [3,1])
C1533734 (UMLS CUI [3,2])
C0358321 (UMLS CUI [3,3])
C0231199 (UMLS CUI [4,1])
C1533734 (UMLS CUI [4,2])
C0003250 (UMLS CUI [4,3])
Decreased cardiac function | Heart Disease Clinical Significance
Item
impaired cardiac function or clinically significant cardiac disease
boolean
C0232166 (UMLS CUI [1])
C0018799 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
Pancreatitis | Pancreatitis, Chronic | Operation on pancreas | Risk factors Pancreatitis
Item
history of acute or chronic pancreatitis, surgery of the pancreas, or any risk factors that may increase the risk of pancreatitis
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
C0193594 (UMLS CUI [3])
C0035648 (UMLS CUI [4,1])
C0030305 (UMLS CUI [4,2])
Communicable Disease Requirement Systemic therapy | Virus Diseases | Bacterial Infections | Mycoses
Item
history of an active infection (viral, bacterial, or fungal) requiring systemic therapy within 28 days before study treatment.
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
C0042769 (UMLS CUI [2])
C0004623 (UMLS CUI [3])
C0026946 (UMLS CUI [4])
HIV Infection
Item
known diagnosis of human immunodeficiency virus (hiv) infection
boolean
C0019693 (UMLS CUI [1])
Viral hepatitis Previous | Hepatitis B | Hepatitis C
Item
evidence of previous hepatitis viral infection such as hepatitis b or hepatitis c
boolean
C0042721 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Adrenal Cortex Hormones | Prednisone U/day | Equivalent
Item
ongoing corticosteroid use (>10 mg/day prednisone or equivalent)
boolean
C0001617 (UMLS CUI [1])
C0032952 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0205163 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant or nursing (lactating) women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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