ID

43880

Description

Study Evaluating TRU-015 in B-Cell Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00521638

Link

https://clinicaltrials.gov/show/NCT00521638

Keywords

  1. 6/29/17 6/29/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Lymphoma, B-Cell NCT00521638

Eligibility Lymphoma, B-Cell NCT00521638

Criteria
Description

Criteria

subjects with cd20-positive, b cell nhl who, after at least 2 prior therapies of probable clinical benefit, have relapsed or refractory disease. the following histologies may be included*: lymphoplasmacytic lymphoma (formerly known as lymphoplasmacytoid lymphoma), splenic marginal zone b cell lymphoma, extranodal marginal zone b cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone b cell lymphoma, follicular lymphoma, mantle cell lymphoma, diffuse large-cell b cell lymphoma, and mediastinal large b cell lymphoma. small lymphocytic lymphoma will be included if it is a primary diagnosis and if the lymphoma cells are < 5.0 x 109/l (5000/mm3) in the peripheral blood. *subjects enrolled in the preliminary efficacy cohorts must have relapsed, refractory, or persistent follicular lymphoma (persistent disease defined as computed tomography (ct) positive for 3 months after last treatment), and must not have received anti-cd20 targeted therapy within 3 months of receiving the first dose of test article. subjects may be considered eligible after a single therapy of probable clinical benefit, if no further standard effective treatment is available in the opinion of the investigator. prior cd20 immunophenotyping of tumors to document b cell nhl is acceptable. if such prior documentation is not available, then the immunophenotype of the current disease must be documented by fine-needle aspirate or biopsy, or by circulating cd20-positive nhl cells from peripheral blood before administration of test article.
Description

ID.1

Data type

boolean

Alias
UMLS CUI [1,1]
C3888518
UMLS CUI [1,2]
C1334634
UMLS CUI [1,3]
C1335726
at least 1 measurable lesion that is 1.5 cm in at least 1 dimension by ct or magnetic resonance imaging (mri), in an area of no prior radiation therapy, or documented progression in an area that was previously irradiated.
Description

ID.2

Data type

boolean

Alias
UMLS CUI [1]
C0221198
recovery to baseline or grade 1 [according to the national cancer institute (nci) common terminology criteria for adverse events (ctcae), version 3.0] from all acute adverse effects of prior therapies (excluding alopecia).
Description

ID.3

Data type

boolean

Alias
UMLS CUI [1,1]
C0237820
UMLS CUI [1,2]
C1290922
main exclusion criteria:
Description

ID.4

Data type

boolean

candidate for potentially curative therapy that is available to the subject, in the clinical opinion of the investigator.
Description

ID.5

Data type

boolean

Alias
UMLS CUI [1]
C1273390
diagnosis of chronic lymphocytic leukemia, burkitt's lymphoma, primary effusion lymphoma, and/or precursor b cell lymphoblastic lymphoma.
Description

ID.6

Data type

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C0006413
UMLS CUI [1,3]
C1292753
UMLS CUI [1,4]
C0855146
prior treatments: radioimmunotherapy; allogeneic hematopoietic stem cell transplant (within 6 months of first dose of study drug); chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational agents (within 4 weeks of first dose of study drug); major surgery not related to debulking surgical procedures (within 3 weeks of first dose of study drug).
Description

ID.7

Data type

boolean

Alias
UMLS CUI [1,1]
C0332152
UMLS CUI [1,2]
C0087111

Similar models

Eligibility Lymphoma, B-Cell NCT00521638

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
ID.1
Item
subjects with cd20-positive, b cell nhl who, after at least 2 prior therapies of probable clinical benefit, have relapsed or refractory disease. the following histologies may be included*: lymphoplasmacytic lymphoma (formerly known as lymphoplasmacytoid lymphoma), splenic marginal zone b cell lymphoma, extranodal marginal zone b cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone b cell lymphoma, follicular lymphoma, mantle cell lymphoma, diffuse large-cell b cell lymphoma, and mediastinal large b cell lymphoma. small lymphocytic lymphoma will be included if it is a primary diagnosis and if the lymphoma cells are < 5.0 x 109/l (5000/mm3) in the peripheral blood. *subjects enrolled in the preliminary efficacy cohorts must have relapsed, refractory, or persistent follicular lymphoma (persistent disease defined as computed tomography (ct) positive for 3 months after last treatment), and must not have received anti-cd20 targeted therapy within 3 months of receiving the first dose of test article. subjects may be considered eligible after a single therapy of probable clinical benefit, if no further standard effective treatment is available in the opinion of the investigator. prior cd20 immunophenotyping of tumors to document b cell nhl is acceptable. if such prior documentation is not available, then the immunophenotype of the current disease must be documented by fine-needle aspirate or biopsy, or by circulating cd20-positive nhl cells from peripheral blood before administration of test article.
boolean
C3888518 (UMLS CUI [1,1])
C1334634 (UMLS CUI [1,2])
C1335726 (UMLS CUI [1,3])
ID.2
Item
at least 1 measurable lesion that is 1.5 cm in at least 1 dimension by ct or magnetic resonance imaging (mri), in an area of no prior radiation therapy, or documented progression in an area that was previously irradiated.
boolean
C0221198 (UMLS CUI [1])
ID.3
Item
recovery to baseline or grade 1 [according to the national cancer institute (nci) common terminology criteria for adverse events (ctcae), version 3.0] from all acute adverse effects of prior therapies (excluding alopecia).
boolean
C0237820 (UMLS CUI [1,1])
C1290922 (UMLS CUI [1,2])
ID.4
Item
main exclusion criteria:
boolean
ID.5
Item
candidate for potentially curative therapy that is available to the subject, in the clinical opinion of the investigator.
boolean
C1273390 (UMLS CUI [1])
ID.6
Item
diagnosis of chronic lymphocytic leukemia, burkitt's lymphoma, primary effusion lymphoma, and/or precursor b cell lymphoblastic lymphoma.
boolean
C0023434 (UMLS CUI [1,1])
C0006413 (UMLS CUI [1,2])
C1292753 (UMLS CUI [1,3])
C0855146 (UMLS CUI [1,4])
ID.7
Item
prior treatments: radioimmunotherapy; allogeneic hematopoietic stem cell transplant (within 6 months of first dose of study drug); chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational agents (within 4 weeks of first dose of study drug); major surgery not related to debulking surgical procedures (within 3 weeks of first dose of study drug).
boolean
C0332152 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])

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