ID

31075

Beschreibung

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

Stichworte

Versionen (1)
  1. 18.07.18 18.07.18 -
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See clinicaltrials.gov

Hochgeladen am

18. Juli 2018

DOI

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

Englisch

Eligibility Non-Hodgkin's Lymphoma NCT00794638

1 Formulare  
Inclusion Criteria
Beschreibung

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.
Beschreibung

Aggressive Non-Hodgkin Lymphoma | Prior Therapy

Datentyp

boolean

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

B-Cell Lymphoma CD20 positive

Datentyp

boolean

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

Diffuse Large B-Cell Lymphoma

Datentyp

boolean

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

Mantle cell lymphoma

Datentyp

boolean

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

Transformation Lymphoma

Datentyp

boolean

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

Follicular Lymphoma Ann Arbor lymphoma staging system

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Age

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

Hospitalization Possible

Datentyp

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
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Criteria Fulfill

Datentyp

boolean

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

Complications Serious | Liver Failure | Kidney Failure

Datentyp

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)
Beschreibung

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

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Investigational New Drugs | Drugs, Non-Prescription

Datentyp

boolean

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

Hematopoietic stem cell transplantation | Radioimmunotherapy

Datentyp

boolean

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

Pregnancy | Childbearing Potential | Breast Feeding

Datentyp

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
Beschreibung

Contraceptive methods Unwilling

Datentyp

boolean

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

Study Subject Participation Status Inappropriate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Ähnliche Modelle

Eligibility Non-Hodgkin's Lymphoma NCT00794638

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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