Information:
Error:
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
Versions (2)
- 6/29/17 6/29/17 -
- 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
- StudyEvent: Eligibility
Similar models
Eligibility Lymphoma, B-Cell NCT00521638
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
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])
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])
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])
C0087111 (UMLS CUI [1,2])