ID

18412

Descrição

SDX-105 in Combination With Rituxan for Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL); ODM derived from: https://clinicaltrials.gov/show/NCT00076349

Link

https://clinicaltrials.gov/show/NCT00076349

Palavras-chave

  1. 03/11/2016 03/11/2016 -
Transferido a

3 de novembro de 2016

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Non-Hodgkin's Lymphoma NCT00076349

Eligibility Non-Hodgkin's Lymphoma NCT00076349

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented b-cell nhl or mantle cell lymphoma
Descrição

B-Cell Lymphomas | Mantle cell lymphoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079731
UMLS CUI [2]
C0334634
cd-20+ tumor
Descrição

Malignant Neoplasm CD20 antigen positive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C3888518
indolent nhl: follicular b-cell lymphoma, diffuse small lymphoma, marginal zone lymphoma
Descrição

indolent lymphoma | Lymphoma, Follicular | Small Lymphocytic Lymphoma | Marginal Zone B-Cell Lymphoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1334170
UMLS CUI [2]
C0024301
UMLS CUI [3]
C0855095
UMLS CUI [4]
C1367654
maximum of three prior chemotherapy regimens
Descrição

Prior Chemotherapy Quantity Maximum

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0806909
age of at least 18 years at screening visit (site specific requirement may differ)
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
refractory to rituximab, defined as progression of disease while being treated with rituximab or progression within 6 months of the last dose of rituximab (when given either as a single agent or in combination)
Descrição

rituximab refractory | Disease Progression | rituximab Single | rituximab Combined

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0393022
UMLS CUI [1,2]
C0205269
UMLS CUI [2]
C0242656
UMLS CUI [3,1]
C0393022
UMLS CUI [3,2]
C0205171
UMLS CUI [4,1]
C0393022
UMLS CUI [4,2]
C0205195
previous chemotherapy or immunotherapy within 3 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin) or failure to recover from adverse events due to any agents administered previously
Descrição

Prior Chemotherapy | Prior Immunotherapy | Nitrosourea | Mitomycin | Adverse reaction to drug | Recovering failed

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C1514461
UMLS CUI [3]
C0028210
UMLS CUI [4]
C0002475
UMLS CUI [5]
C0041755
UMLS CUI [6,1]
C0521108
UMLS CUI [6,2]
C0231175
use of investigational agents within 28 days of study
Descrição

Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
history of prior high dose chemotherapy with allogeneic stem cell support
Descrição

Prior Chemotherapy High dose | Allogeneic Stem Cell Transplantation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0444956
UMLS CUI [2]
C2242529
history of prior radioimmunotherapy
Descrição

Radioimmunotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0085101

Similar models

Eligibility Non-Hodgkin's Lymphoma NCT00076349

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
B-Cell Lymphomas | Mantle cell lymphoma
Item
documented b-cell nhl or mantle cell lymphoma
boolean
C0079731 (UMLS CUI [1])
C0334634 (UMLS CUI [2])
Malignant Neoplasm CD20 antigen positive
Item
cd-20+ tumor
boolean
C0006826 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])
indolent lymphoma | Lymphoma, Follicular | Small Lymphocytic Lymphoma | Marginal Zone B-Cell Lymphoma
Item
indolent nhl: follicular b-cell lymphoma, diffuse small lymphoma, marginal zone lymphoma
boolean
C1334170 (UMLS CUI [1])
C0024301 (UMLS CUI [2])
C0855095 (UMLS CUI [3])
C1367654 (UMLS CUI [4])
Prior Chemotherapy Quantity Maximum
Item
maximum of three prior chemotherapy regimens
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Age
Item
age of at least 18 years at screening visit (site specific requirement may differ)
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
rituximab refractory | Disease Progression | rituximab Single | rituximab Combined
Item
refractory to rituximab, defined as progression of disease while being treated with rituximab or progression within 6 months of the last dose of rituximab (when given either as a single agent or in combination)
boolean
C0393022 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
C0393022 (UMLS CUI [3,1])
C0205171 (UMLS CUI [3,2])
C0393022 (UMLS CUI [4,1])
C0205195 (UMLS CUI [4,2])
Prior Chemotherapy | Prior Immunotherapy | Nitrosourea | Mitomycin | Adverse reaction to drug | Recovering failed
Item
previous chemotherapy or immunotherapy within 3 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin) or failure to recover from adverse events due to any agents administered previously
boolean
C1514457 (UMLS CUI [1])
C1514461 (UMLS CUI [2])
C0028210 (UMLS CUI [3])
C0002475 (UMLS CUI [4])
C0041755 (UMLS CUI [5])
C0521108 (UMLS CUI [6,1])
C0231175 (UMLS CUI [6,2])
Investigational New Drugs
Item
use of investigational agents within 28 days of study
boolean
C0013230 (UMLS CUI [1])
Prior Chemotherapy High dose | Allogeneic Stem Cell Transplantation
Item
history of prior high dose chemotherapy with allogeneic stem cell support
boolean
C1514457 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
C2242529 (UMLS CUI [2])
Radioimmunotherapy
Item
history of prior radioimmunotherapy
boolean
C0085101 (UMLS CUI [1])

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