ID

21758

Beschreibung

A Study of Galiximab + Rituximab Versus Rituximab + Placebo in Follicular Non-Hodgkin's Lymphoma (NHL); ODM derived from: https://clinicaltrials.gov/show/NCT00363636

Link

https://clinicaltrials.gov/show/NCT00363636

Stichworte

Versionen (1)
  1. 28-04-17 28-04-17 -
Hochgeladen am

28 april 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Lymphoma, Non-Hodgkin's NCT00363636

Englisch

Eligibility Lymphoma, Non-Hodgkin's NCT00363636

1 Formulare  
Criteria
Beschreibung

Criteria

key inclusion criteria:
Beschreibung

Inclusion criteria Main

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1542147
aged >= 18 years old at the time of informed consent.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
histologically confirmed follicular grade 1-3a nhl.
Beschreibung

Follicular Lymphoma Ann Arbor lymphoma staging system

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0432516
relapsed or progressive disease after at least 1 prior chemotherapy requiring treatment.
Beschreibung

Chemotherapy Quantity Requirement Therapeutic procedure | Recurrent disease | Progressive Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0087111
UMLS CUI [2]
C0277556
UMLS CUI [3]
C1335499
bidimensionally measurable disease with at least 1 lesion >= 2.0 cm in a single dimension.
Beschreibung

Measurable Disease 2-Dimensional | Lesion Diameter Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C1265611
acceptable hematologic, hepatic, and renal function parameters.
Beschreibung

Hematologic function | Liver function | Renal function

Datentyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, autologous bone marrow or stem cell transplant, or investigational drugs.
Beschreibung

Toxicity Patient recovered | Operative Surgical Procedures | Therapeutic radiology procedure | Chemotherapy | Biological treatment | Autologous bone marrow transplant | Transplantation of autologous hematopoietic stem cell | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C1115804
UMLS CUI [2]
C0543467
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0392920
UMLS CUI [5]
C1531518
UMLS CUI [6]
C0194037
UMLS CUI [7]
C1831743
UMLS CUI [8]
C0013230
key exclusion criteria:
Beschreibung

Exclusion Criteria Main

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
follicular lymphoma grade 3b.
Beschreibung

Follicular Lymphoma Ann Arbor lymphoma staging system

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0432516
rituximab refractory or refractory to anti-cd20 radioimmunotherapy (no response to prior rituximab or prior rituximab-containing regimen, or a response with a ttp of less than 6 months).
Beschreibung

rituximab refractory | Radioimmunotherapy Against CD20 Antigens refractory | Thrombotic Thrombocytopenic Purpura Duration Disease Response

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0393022
UMLS CUI [1,2]
C0205269
UMLS CUI [2,1]
C0085101
UMLS CUI [2,2]
C0521124
UMLS CUI [2,3]
C0054946
UMLS CUI [2,4]
C0205269
UMLS CUI [3,1]
C0034155
UMLS CUI [3,2]
C0449238
UMLS CUI [3,3]
C1704632
cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks prior to study day 1 (6 weeks if nitrosourea or mitomycin c).
Beschreibung

Therapeutic radiology procedure Malignant Neoplasms | Biological treatment Malignant Neoplasms | Chemotherapy Malignant Neoplasms | Nitrosourea | Mitomycin-c

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C1531518
UMLS CUI [2,2]
C0006826
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0006826
UMLS CUI [4]
C0028210
UMLS CUI [5]
C0002475
prior lymphoma vaccine therapy within 12 months prior to study day 1.
Beschreibung

Vaccine Therapy Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042209
UMLS CUI [1,2]
C0024299
prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to study day 1.
Beschreibung

Antibody therapy Lymphoma | Radioimmunotherapy Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0281176
UMLS CUI [1,2]
C0024299
UMLS CUI [2,1]
C0085101
UMLS CUI [2,2]
C0024299
autologous bone marrow or stem cell transplant within 6 months prior to study day 1.
Beschreibung

Autologous bone marrow transplant | Transplantation of autologous hematopoietic stem cell

Datentyp

boolean

Alias
UMLS CUI [1]
C0194037
UMLS CUI [2]
C1831743
prior allogeneic transplant.
Beschreibung

Transplantation, Homologous

Datentyp

boolean

Alias
UMLS CUI [1]
C0040739
transfusion-dependent subjects.
Beschreibung

Blood transfusion dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C1698624
another primary malignancy requiring active treatment (except hormonal therapy).
Beschreibung

Primary tumor Requirement Therapeutic procedure | Hormone Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
UMLS CUI [2]
C0279025
serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions, which would compromise protocol objectives in the opinion of the investigator and/or the sponsor.
Beschreibung

Disease Serious | Congestive heart failure | Hydronephrosis | Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled | Condition compromises Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0020295
UMLS CUI [4,1]
C0004623
UMLS CUI [4,2]
C0205318
UMLS CUI [5,1]
C0042769
UMLS CUI [5,2]
C0205318
UMLS CUI [6,1]
C0026946
UMLS CUI [6,2]
C0205318
UMLS CUI [7,1]
C0348080
UMLS CUI [7,2]
C2945640
UMLS CUI [7,3]
C0525058
new york heart association class iii or iv cardiac disease or myocardial infarction within 6 months prior to study day 1.
Beschreibung

Heart Disease New York Heart Association Classification | Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0027051
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Ähnliche Modelle

Eligibility Lymphoma, Non-Hodgkin's NCT00363636

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion criteria Main
Item
key inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Age
Item
aged >= 18 years old at the time of informed consent.
boolean
C0001779 (UMLS CUI [1])
Follicular Lymphoma Ann Arbor lymphoma staging system
Item
histologically confirmed follicular grade 1-3a nhl.
boolean
C0024301 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
Chemotherapy Quantity Requirement Therapeutic procedure | Recurrent disease | Progressive Disease
Item
relapsed or progressive disease after at least 1 prior chemotherapy requiring treatment.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0277556 (UMLS CUI [2])
C1335499 (UMLS CUI [3])
Measurable Disease 2-Dimensional | Lesion Diameter Quantity
Item
bidimensionally measurable disease with at least 1 lesion >= 2.0 cm in a single dimension.
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Hematologic function | Liver function | Renal function
Item
acceptable hematologic, hepatic, and renal function parameters.
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Toxicity Patient recovered | Operative Surgical Procedures | Therapeutic radiology procedure | Chemotherapy | Biological treatment | Autologous bone marrow transplant | Transplantation of autologous hematopoietic stem cell | Investigational New Drugs
Item
recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, autologous bone marrow or stem cell transplant, or investigational drugs.
boolean
C0600688 (UMLS CUI [1,1])
C1115804 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C1531518 (UMLS CUI [5])
C0194037 (UMLS CUI [6])
C1831743 (UMLS CUI [7])
C0013230 (UMLS CUI [8])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Follicular Lymphoma Ann Arbor lymphoma staging system
Item
follicular lymphoma grade 3b.
boolean
C0024301 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
rituximab refractory | Radioimmunotherapy Against CD20 Antigens refractory | Thrombotic Thrombocytopenic Purpura Duration Disease Response
Item
rituximab refractory or refractory to anti-cd20 radioimmunotherapy (no response to prior rituximab or prior rituximab-containing regimen, or a response with a ttp of less than 6 months).
boolean
C0393022 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0085101 (UMLS CUI [2,1])
C0521124 (UMLS CUI [2,2])
C0054946 (UMLS CUI [2,3])
C0205269 (UMLS CUI [2,4])
C0034155 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
C1704632 (UMLS CUI [3,3])
Therapeutic radiology procedure Malignant Neoplasms | Biological treatment Malignant Neoplasms | Chemotherapy Malignant Neoplasms | Nitrosourea | Mitomycin-c
Item
cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks prior to study day 1 (6 weeks if nitrosourea or mitomycin c).
boolean
C1522449 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C1531518 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C0028210 (UMLS CUI [4])
C0002475 (UMLS CUI [5])
Vaccine Therapy Lymphoma
Item
prior lymphoma vaccine therapy within 12 months prior to study day 1.
boolean
C0042209 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
Antibody therapy Lymphoma | Radioimmunotherapy Lymphoma
Item
prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to study day 1.
boolean
C0281176 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
C0085101 (UMLS CUI [2,1])
C0024299 (UMLS CUI [2,2])
Autologous bone marrow transplant | Transplantation of autologous hematopoietic stem cell
Item
autologous bone marrow or stem cell transplant within 6 months prior to study day 1.
boolean
C0194037 (UMLS CUI [1])
C1831743 (UMLS CUI [2])
Transplantation, Homologous
Item
prior allogeneic transplant.
boolean
C0040739 (UMLS CUI [1])
Blood transfusion dependent
Item
transfusion-dependent subjects.
boolean
C1698624 (UMLS CUI [1])
Primary tumor Requirement Therapeutic procedure | Hormone Therapy
Item
another primary malignancy requiring active treatment (except hormonal therapy).
boolean
C0677930 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0279025 (UMLS CUI [2])
Disease Serious | Congestive heart failure | Hydronephrosis | Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled | Condition compromises Protocol Compliance
Item
serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions, which would compromise protocol objectives in the opinion of the investigator and/or the sponsor.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2])
C0020295 (UMLS CUI [3])
C0004623 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0042769 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0026946 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C0348080 (UMLS CUI [7,1])
C2945640 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
Heart Disease New York Heart Association Classification | Myocardial Infarction
Item
new york heart association class iii or iv cardiac disease or myocardial infarction within 6 months prior to study day 1.
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
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