ID

31075

Descripción

A Phase I Clinical Trial to Assess the Safety of SyB L-0501 in Combination With Rituximab to Patients With Aggressive B-cell Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00794638

Link

https://clinicaltrials.gov/show/NCT00794638

Palabras clave

Versiones (1)
  1. 18/7/18 18/7/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

18 de julio de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Non-Hodgkin's Lymphoma NCT00794638

Inglés

Eligibility Non-Hodgkin's Lymphoma NCT00794638

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
aggressive b-cell non-hodgkin's lymphoma patients with prior therapy who satisfy the conditions listed below. no restrictions regarding gender.
Descripción

Aggressive Non-Hodgkin Lymphoma | Prior Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1332225
UMLS CUI [2]
C1514463
patients with the following histologically confirmed cd20(+) b-cell non-hodgkin's lymphoma:
Descripción

B-Cell Lymphoma CD20 positive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079731
UMLS CUI [1,2]
C3888518
1. diffuse large b-cell lymphoma
Descripción

Diffuse Large B-Cell Lymphoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079744
2. mantle cell lymphoma
Descripción

Mantle cell lymphoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0334634
3. transformed lymphoma
Descripción

Transformation Lymphoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0040682
UMLS CUI [1,2]
C0024299
4. follicular lymphoma (grade 3)
Descripción

Follicular Lymphoma Ann Arbor lymphoma staging system

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0432516
fail to cr in prior chemotherapy, or relapse following cr or recurrence following pr.
Descripción

Complete remission failed Prior Chemotherapy | Recurrent disease Post Complete remission | Recurrent disease Post Partial response

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0677874
UMLS CUI [1,2]
C0231175
UMLS CUI [1,3]
C1514457
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0677874
UMLS CUI [3,1]
C0277556
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C1521726
patients who are judged to carry no effect from the prior therapy (cancer chemotherapy, antibody therapy and radiation/ radiotherapy.
Descripción

Absence Effect Due to Prior Therapy | Chemotherapy | Antibody therapy | Therapeutic radiology procedure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1280500
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C1514463
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0281176
UMLS CUI [4]
C1522449
patients aged from 20 to 75 years at the time informed consent is obtained
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
patients with adequately maintained organ functions (e.g., bone marrow, heart, lung, liver, and kidney functions)
Descripción

Organ function | Bone Marrow function | Cardiac function | Pulmonary function | Liver function | Renal function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
UMLS CUI [3]
C0232164
UMLS CUI [4]
C0231921
UMLS CUI [5]
C0232741
UMLS CUI [6]
C0232804
patients who can be hospitalized during the first cycle
Descripción

Hospitalization Possible

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0332149
patients capable of personally giving voluntary informed consent in writing to participate in the study
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who meet any of the following criteria will be excluded.
Descripción

Criteria Fulfill

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
patients with serious complications (hepatic or renal failure)
Descripción

Complications Serious | Liver Failure | Kidney Failure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0085605
UMLS CUI [3]
C0035078
patients with complications or medical history of serious cardiac disease (e.g., myocardial infarction, ischemic heart disease)
Descripción

Complications Heart Disease Serious | Heart Disease Serious | Myocardial Infarction | Myocardial Ischemia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0018799
UMLS CUI [1,3]
C0205404
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0205404
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0151744
patients with serious gastrointestinal symptoms (e.g., severe nausea, vomiting, or diarrhea)
Descripción

Gastrointestinal symptom Serious | Nausea Severe | Vomiting Severe | Severe diarrhea

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0027497
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0042963
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C1443924
patients positive for hbs antigen, hcv antibody, or hiv antibody
Descripción

Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV antibody positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0281863
UMLS CUI [3]
C0920548
patients who received other investigational drug or unapproved medication within 3 months before registration in this study
Descripción

Investigational New Drugs | Drugs, Non-Prescription

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0013231
patients who had history of hematopoietic stem cell transplantation or radioimmunotherapy
Descripción

Hematopoietic stem cell transplantation | Radioimmunotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0472699
UMLS CUI [2]
C0085101
patients who are pregnant, of childbearing potential, or lactating
Descripción

Pregnancy | Childbearing Potential | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C3831118
UMLS CUI [3]
C0006147
patients, whether male or female, who do not agree to contraception
Descripción

Contraceptive methods Unwilling

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0558080
patients otherwise judged by investigator or sub investigator to be unsuitable
Descripción

Study Subject Participation Status Inappropriate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Similar models

Eligibility Non-Hodgkin's Lymphoma NCT00794638

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Aggressive Non-Hodgkin Lymphoma | Prior Therapy
Item
aggressive b-cell non-hodgkin's lymphoma patients with prior therapy who satisfy the conditions listed below. no restrictions regarding gender.
boolean
C1332225 (UMLS CUI [1])
C1514463 (UMLS CUI [2])
B-Cell Lymphoma CD20 positive
Item
patients with the following histologically confirmed cd20(+) b-cell non-hodgkin's lymphoma:
boolean
C0079731 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])
Diffuse Large B-Cell Lymphoma
Item
1. diffuse large b-cell lymphoma
boolean
C0079744 (UMLS CUI [1])
Mantle cell lymphoma
Item
2. mantle cell lymphoma
boolean
C0334634 (UMLS CUI [1])
Transformation Lymphoma
Item
3. transformed lymphoma
boolean
C0040682 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
Follicular Lymphoma Ann Arbor lymphoma staging system
Item
4. follicular lymphoma (grade 3)
boolean
C0024301 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
Complete remission failed Prior Chemotherapy | Recurrent disease Post Complete remission | Recurrent disease Post Partial response
Item
fail to cr in prior chemotherapy, or relapse following cr or recurrence following pr.
boolean
C0677874 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C1514457 (UMLS CUI [1,3])
C0277556 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0677874 (UMLS CUI [2,3])
C0277556 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C1521726 (UMLS CUI [3,3])
Absence Effect Due to Prior Therapy | Chemotherapy | Antibody therapy | Therapeutic radiology procedure
Item
patients who are judged to carry no effect from the prior therapy (cancer chemotherapy, antibody therapy and radiation/ radiotherapy.
boolean
C0332197 (UMLS CUI [1,1])
C1280500 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C1514463 (UMLS CUI [1,4])
C0392920 (UMLS CUI [2])
C0281176 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
Age
Item
patients aged from 20 to 75 years at the time informed consent is obtained
boolean
C0001779 (UMLS CUI [1])
Organ function | Bone Marrow function | Cardiac function | Pulmonary function | Liver function | Renal function
Item
patients with adequately maintained organ functions (e.g., bone marrow, heart, lung, liver, and kidney functions)
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0232164 (UMLS CUI [3])
C0231921 (UMLS CUI [4])
C0232741 (UMLS CUI [5])
C0232804 (UMLS CUI [6])
Hospitalization Possible
Item
patients who can be hospitalized during the first cycle
boolean
C0019993 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
Informed Consent
Item
patients capable of personally giving voluntary informed consent in writing to participate in the study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
patients who meet any of the following criteria will be excluded.
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Complications Serious | Liver Failure | Kidney Failure
Item
patients with serious complications (hepatic or renal failure)
boolean
C0009566 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0085605 (UMLS CUI [2])
C0035078 (UMLS CUI [3])
Complications Heart Disease Serious | Heart Disease Serious | Myocardial Infarction | Myocardial Ischemia
Item
patients with complications or medical history of serious cardiac disease (e.g., myocardial infarction, ischemic heart disease)
boolean
C0009566 (UMLS CUI [1,1])
C0018799 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0018799 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0151744 (UMLS CUI [4])
Gastrointestinal symptom Serious | Nausea Severe | Vomiting Severe | Severe diarrhea
Item
patients with serious gastrointestinal symptoms (e.g., severe nausea, vomiting, or diarrhea)
boolean
C0426576 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0027497 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0042963 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C1443924 (UMLS CUI [4])
Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV antibody positive
Item
patients positive for hbs antigen, hcv antibody, or hiv antibody
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0920548 (UMLS CUI [3])
Investigational New Drugs | Drugs, Non-Prescription
Item
patients who received other investigational drug or unapproved medication within 3 months before registration in this study
boolean
C0013230 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
Hematopoietic stem cell transplantation | Radioimmunotherapy
Item
patients who had history of hematopoietic stem cell transplantation or radioimmunotherapy
boolean
C0472699 (UMLS CUI [1])
C0085101 (UMLS CUI [2])
Pregnancy | Childbearing Potential | Breast Feeding
Item
patients who are pregnant, of childbearing potential, or lactating
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Contraceptive methods Unwilling
Item
patients, whether male or female, who do not agree to contraception
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Study Subject Participation Status Inappropriate
Item
patients otherwise judged by investigator or sub investigator to be unsuitable
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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