ID

41205

Description

S0801 Iodine I 131 Tositumomab, Rituximab, and Combination Chemotherapy in Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00770224

Link

https://clinicaltrials.gov/show/NCT00770224

Keywords

Versions (1)
  1. 7/13/20 7/13/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 13, 2020

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License

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00770224

English

Eligibility Lymphoma NCT00770224

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00770224
Criteria
Description

Criteria

histologically confirmed* grade 1, 2, or 3 follicular b-cell non-hodgkin lymphoma meeting the following criteria:
Description

Follicular Lymphoma Grade

Data type

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0441800
bulky stage ii or stage iii or iv disease
Description

Disease TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
diffuse large cell component must be < 25% of the biopsy
Description

Diffuse Large B-Cell Lymphoma Component | Percentage Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C1705248
UMLS CUI [2,1]
C0439165
UMLS CUI [2,2]
C0005558
confirmed cluster of differentiation antigen 20 (cd20) antigen-positive disease note: *needle aspiration or cytology are not considered adequate for pathology review
Description

Disease CD20 positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3888518
patient must have unilateral or bilateral bone marrow aspirate and biopsy performed within 42 days
Description

Marrow aspirate Unilateral | Marrow aspirate Bilateral | Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0857285
UMLS CUI [1,2]
C0205092
UMLS CUI [2,1]
C0857285
UMLS CUI [2,2]
C0238767
UMLS CUI [3]
C0005558
positive biopsy performed > 42 days but < 6 months allowed
Description

Biopsy Performed Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0884358
UMLS CUI [1,3]
C1514241
previously untreated disease
Description

Disease Untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332155
bidimensionally measurable disease
Description

Measurable Disease 2-Dimensional

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
no clinical evidence of central nervous system (cns) involvement by lymphoma
Description

Absence Central Nervous System Involvement Lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C4050309
UMLS CUI [1,3]
C0024299
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
zubrod performance status 0-2
Description

Zubrod Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C3714786
cardiac ejection fraction ≥ 45% by multigated acquisition scan (muga) or echo
Description

Cardiac ejection fraction MUGA scan | Cardiac ejection fraction Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0232174
UMLS CUI [1,2]
C0521317
UMLS CUI [2,1]
C0232174
UMLS CUI [2,2]
C0013516
no significant cardiac abnormalities
Description

Cardiac abnormalities Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0018798
UMLS CUI [1,2]
C0332197
no known hiv positivity
Description

HIV Seropositivity Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0019699
UMLS CUI [1,2]
C0332197
no requirement for continuous supplemental oxygen therapy
Description

Requirement Absent Supplemental oxygen therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0184633
no other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage i or ii cancer from which the patient is currently in complete remission
Description

Cancer Other Absent | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Malignant Neoplasm TNM clinical staging Treated | Exception Malignant Neoplasm In complete remission

Data type

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0006826
UMLS CUI [5,3]
C3258246
UMLS CUI [5,4]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0006826
UMLS CUI [6,3]
C0677874
not pregnant or nursing
Description

Pregnancy Absent | Breast Feeding Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
fertile patients must use effective contraception during and for 12 months after completion of maintenance therapy
Description

Females & males of reproductive potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
prior concurrent therapy:
Description

Prior Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514463
no prior chemotherapy, radiotherapy, or antibody therapy for lymphoma
Description

Prior Chemotherapy Absent Lymphoma | Prior Radiation Therapy Absent Lymphoma | Antibody Therapy Absent Lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0024299
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0024299
UMLS CUI [3,1]
C0281176
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0024299
no prior solid organ transplantation
Description

Solid organ transplant Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0730400
UMLS CUI [1,2]
C0332197
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Similar models

Eligibility Lymphoma NCT00770224

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00770224
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Follicular Lymphoma Grade
Item
histologically confirmed* grade 1, 2, or 3 follicular b-cell non-hodgkin lymphoma meeting the following criteria:
boolean
C0024301 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Disease TNM clinical staging
Item
bulky stage ii or stage iii or iv disease
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Diffuse Large B-Cell Lymphoma Component | Percentage Biopsy
Item
diffuse large cell component must be < 25% of the biopsy
boolean
C0079744 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0439165 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
Disease CD20 positive
Item
confirmed cluster of differentiation antigen 20 (cd20) antigen-positive disease note: *needle aspiration or cytology are not considered adequate for pathology review
boolean
C0012634 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])
Marrow aspirate Unilateral | Marrow aspirate Bilateral | Biopsy
Item
patient must have unilateral or bilateral bone marrow aspirate and biopsy performed within 42 days
boolean
C0857285 (UMLS CUI [1,1])
C0205092 (UMLS CUI [1,2])
C0857285 (UMLS CUI [2,1])
C0238767 (UMLS CUI [2,2])
C0005558 (UMLS CUI [3])
Biopsy Performed Positive
Item
positive biopsy performed > 42 days but < 6 months allowed
boolean
C0005558 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
Disease Untreated
Item
previously untreated disease
boolean
C0012634 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Measurable Disease 2-Dimensional
Item
bidimensionally measurable disease
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
Absence Central Nervous System Involvement Lymphoma
Item
no clinical evidence of central nervous system (cns) involvement by lymphoma
boolean
C0332197 (UMLS CUI [1,1])
C4050309 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Zubrod Performance Status
Item
zubrod performance status 0-2
boolean
C3714786 (UMLS CUI [1])
Cardiac ejection fraction MUGA scan | Cardiac ejection fraction Echocardiography
Item
cardiac ejection fraction ≥ 45% by multigated acquisition scan (muga) or echo
boolean
C0232174 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Cardiac abnormalities Absent
Item
no significant cardiac abnormalities
boolean
C0018798 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
HIV Seropositivity Absent
Item
no known hiv positivity
boolean
C0019699 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Requirement Absent Supplemental oxygen therapy
Item
no requirement for continuous supplemental oxygen therapy
boolean
C1514873 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0184633 (UMLS CUI [1,3])
Cancer Other Absent | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Malignant Neoplasm TNM clinical staging Treated | Exception Malignant Neoplasm In complete remission
Item
no other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage i or ii cancer from which the patient is currently in complete remission
boolean
C1707251 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0006826 (UMLS CUI [5,2])
C3258246 (UMLS CUI [5,3])
C1522326 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0006826 (UMLS CUI [6,2])
C0677874 (UMLS CUI [6,3])
Pregnancy Absent | Breast Feeding Absent
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Females & males of reproductive potential Contraceptive methods
Item
fertile patients must use effective contraception during and for 12 months after completion of maintenance therapy
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Prior Therapy
Item
prior concurrent therapy:
boolean
C1514463 (UMLS CUI [1])
Prior Chemotherapy Absent Lymphoma | Prior Radiation Therapy Absent Lymphoma | Antibody Therapy Absent Lymphoma
Item
no prior chemotherapy, radiotherapy, or antibody therapy for lymphoma
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,3])
C0279134 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0024299 (UMLS CUI [2,3])
C0281176 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0024299 (UMLS CUI [3,3])
Solid organ transplant Absent
Item
no prior solid organ transplantation
boolean
C0730400 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
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