ID

41251

Description

Autologous Vaccine for Follicular Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01022255

Link

https://clinicaltrials.gov/show/NCT01022255

Keywords

Versions (1)
  1. 7/24/20 7/24/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 24, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Lymphoma, Follicular NCT01022255

English

Eligibility Lymphoma, Follicular NCT01022255

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with histologically proven follicular lymphoma (grade 1, 2, or 3a), in clinical relapse/progression requiring treatment
Description

Follicular Lymphoma Ann Arbor lymphoma staging system | Recurrent disease | Disease Progression | Treatment required

Data type

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0432516
UMLS CUI [2]
C0277556
UMLS CUI [3]
C0242656
UMLS CUI [4]
C0332121
subjects must have had first line treatment consisting of rituximab with or without rituximab maintenance therapy (i.e. rituximab monotherapy, r-chop, r-cvp, r-fnd, etc)
Description

First line treatment | rituximab | R-CHOP Regimen | R-CVP Regimen | fludarabine | mitoxantrone | dexamethasone

Data type

boolean

Alias
UMLS CUI [1]
C1708063
UMLS CUI [2]
C0393022
UMLS CUI [3]
C0393023
UMLS CUI [4]
C1882520
UMLS CUI [5]
C0059985
UMLS CUI [6]
C0026259
UMLS CUI [7]
C0011777
at least 4 months since last rituximab exposure
Description

Exposure to Rituximab

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0393022
subjects may have had any number of prior treatment regimens. if enrolled with transformed follicular lymphoma, study subject must have had anthracycline in a previous regimen
Description

Prior Therapy Quantity | Transformation Follicular Lymphoma | Anthracyclines

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0040682
UMLS CUI [2,2]
C0024301
UMLS CUI [3]
C0282564
eastern cooperative oncology group (ecog) performance status of 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of at least 12 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
presence of at least a 2x2 cm in diameter lymph node (either a single lymph node or combined volume of lymphoid tissue) accessible for excision; for histological confirmation of diagnosis and for manufacture of the vaccine
Description

Lymph node Diameter | Amenable Excision

Data type

boolean

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C1301886
UMLS CUI [2,1]
C3900053
UMLS CUI [2,2]
C0728940
measurable disease in neck, chest, abdomen, or pelvis as assessed by computed tomography (ct) scan such that response to 2nd line chemotherapy can be defined by the criteria of cheson et al (jco 2007; 25:579, see appendix 15.2 and ref 65). pet scan results are not required for enrollment
Description

Measurable Disease Neck CT scan | Measurable Disease Chest CT scan | Measurable Disease Abdomen CT scan | Measurable Disease Pelvis CT scan | Response Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0027530
UMLS CUI [1,3]
C0040405
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0817096
UMLS CUI [2,3]
C0040405
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C0000726
UMLS CUI [3,3]
C0040405
UMLS CUI [4,1]
C1513041
UMLS CUI [4,2]
C0030797
UMLS CUI [4,3]
C0040405
UMLS CUI [5,1]
C1704632
UMLS CUI [5,2]
C0392920
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
exposure to rituximab or anticd-20 directed therapy within the 4 months prior to enrollment
Description

Exposure to Rituximab | Targeted Therapy Against CD20

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0393022
UMLS CUI [2,1]
C2985566
UMLS CUI [2,2]
C0521124
UMLS CUI [2,3]
C0054946
history of human immunodeficiency virus (hiv), hepatitis b virus (hbv), or hepatitis c virus (hcv) infection
Description

HIV Infection | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
active clinically serious infections (> grade 2 national cancer institute common toxic criteria [nci-ctc] version 3.0)
Description

Communicable Diseases Serious CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1516728
symptomatic metastatic brain or meningeal tumors including lymphoma unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry
Description

Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm of meninges Symptomatic | Primary cerebral lymphoma | Meningeal Lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C4302368
UMLS CUI [2,2]
C0231220
UMLS CUI [3]
C0240803
UMLS CUI [4]
C2213017
history of organ allograft
Description

Homologous Transplantation Organ

Data type

boolean

Alias
UMLS CUI [1,1]
C0040739
UMLS CUI [1,2]
C0178784
patients undergoing renal dialysis
Description

Dialysis procedure

Data type

boolean

Alias
UMLS CUI [1]
C0011946
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Similar models

Eligibility Lymphoma, Follicular NCT01022255

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Follicular Lymphoma Ann Arbor lymphoma staging system | Recurrent disease | Disease Progression | Treatment required
Item
subjects with histologically proven follicular lymphoma (grade 1, 2, or 3a), in clinical relapse/progression requiring treatment
boolean
C0024301 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
C0332121 (UMLS CUI [4])
First line treatment | rituximab | R-CHOP Regimen | R-CVP Regimen | fludarabine | mitoxantrone | dexamethasone
Item
subjects must have had first line treatment consisting of rituximab with or without rituximab maintenance therapy (i.e. rituximab monotherapy, r-chop, r-cvp, r-fnd, etc)
boolean
C1708063 (UMLS CUI [1])
C0393022 (UMLS CUI [2])
C0393023 (UMLS CUI [3])
C1882520 (UMLS CUI [4])
C0059985 (UMLS CUI [5])
C0026259 (UMLS CUI [6])
C0011777 (UMLS CUI [7])
Exposure to Rituximab
Item
at least 4 months since last rituximab exposure
boolean
C0332157 (UMLS CUI [1,1])
C0393022 (UMLS CUI [1,2])
Prior Therapy Quantity | Transformation Follicular Lymphoma | Anthracyclines
Item
subjects may have had any number of prior treatment regimens. if enrolled with transformed follicular lymphoma, study subject must have had anthracycline in a previous regimen
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0040682 (UMLS CUI [2,1])
C0024301 (UMLS CUI [2,2])
C0282564 (UMLS CUI [3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 12 months
boolean
C0023671 (UMLS CUI [1])
Lymph node Diameter | Amenable Excision
Item
presence of at least a 2x2 cm in diameter lymph node (either a single lymph node or combined volume of lymphoid tissue) accessible for excision; for histological confirmation of diagnosis and for manufacture of the vaccine
boolean
C0024204 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C3900053 (UMLS CUI [2,1])
C0728940 (UMLS CUI [2,2])
Measurable Disease Neck CT scan | Measurable Disease Chest CT scan | Measurable Disease Abdomen CT scan | Measurable Disease Pelvis CT scan | Response Chemotherapy
Item
measurable disease in neck, chest, abdomen, or pelvis as assessed by computed tomography (ct) scan such that response to 2nd line chemotherapy can be defined by the criteria of cheson et al (jco 2007; 25:579, see appendix 15.2 and ref 65). pet scan results are not required for enrollment
boolean
C1513041 (UMLS CUI [1,1])
C0027530 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C0817096 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
C1513041 (UMLS CUI [3,1])
C0000726 (UMLS CUI [3,2])
C0040405 (UMLS CUI [3,3])
C1513041 (UMLS CUI [4,1])
C0030797 (UMLS CUI [4,2])
C0040405 (UMLS CUI [4,3])
C1704632 (UMLS CUI [5,1])
C0392920 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Exposure to Rituximab | Targeted Therapy Against CD20
Item
exposure to rituximab or anticd-20 directed therapy within the 4 months prior to enrollment
boolean
C0332157 (UMLS CUI [1,1])
C0393022 (UMLS CUI [1,2])
C2985566 (UMLS CUI [2,1])
C0521124 (UMLS CUI [2,2])
C0054946 (UMLS CUI [2,3])
HIV Infection | Hepatitis B | Hepatitis C
Item
history of human immunodeficiency virus (hiv), hepatitis b virus (hbv), or hepatitis c virus (hcv) infection
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Communicable Diseases Serious CTCAE Grades
Item
active clinically serious infections (> grade 2 national cancer institute common toxic criteria [nci-ctc] version 3.0)
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm of meninges Symptomatic | Primary cerebral lymphoma | Meningeal Lymphoma
Item
symptomatic metastatic brain or meningeal tumors including lymphoma unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C4302368 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0240803 (UMLS CUI [3])
C2213017 (UMLS CUI [4])
Homologous Transplantation Organ
Item
history of organ allograft
boolean
C0040739 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
Dialysis procedure
Item
patients undergoing renal dialysis
boolean
C0011946 (UMLS CUI [1])
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