ID

24733

Beschrijving

Phase I Trial of Clofarabine in Combo w/ HD Etoposide & Cyclophosphamide and APBSCT for Pts w/ High-Risk or Refractory NHL; ODM derived from: https://clinicaltrials.gov/show/NCT00477945

Link

https://clinicaltrials.gov/show/NCT00477945

Trefwoorden

Versies (1)
  1. 15-08-17 15-08-17 -
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15 augustus 2017

DOI

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Creative Commons BY 4.0
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Eligibility Non Hodgkin's Lymphoma NCT00477945

Engels

Eligibility Non Hodgkin's Lymphoma NCT00477945

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. documentation of disease. patients must have one of the following disease types:
Beschrijving

types of diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0457464
diffuse large cell non-hodgkin's lymphoma, mediastinal b-cell lymphoma, or peripheral t-cell lymphoma that is:
Beschrijving

Diffuse Large B-Cell Lymphoma | Mediastinal (Thymic) Large B-Cell Lymphoma | Peripheral T-Cell Lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C0079744
UMLS CUI [2]
C1292754
UMLS CUI [3]
C0079774
primary refractory (achievement less than complete response)
Beschrijving

Primary Refractory | Complete response Less Than

Datatype

boolean

Alias
UMLS CUI [1]
C2347678
UMLS CUI [2,1]
C0677874
UMLS CUI [2,2]
C0439092
relapsed and refractory (achievement less than a partial response) to at least a single salvage therapy
Beschrijving

Salvage Therapy Quantity Recurrent disease | Salvage Therapy Quantity Refractory | Partial response Less Than

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085405
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0277556
UMLS CUI [2,1]
C0085405
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0205269
UMLS CUI [3,1]
C1521726
UMLS CUI [3,2]
C0439092
relapsed or primary refractory follicular lymphoma (fl) with a high fl international prognostic index.
Beschrijving

Recurrent Follicular Lymphoma | Refractory Follicular Lymphoma Primary | Follicular Lymphoma International Prognostic Index High

Datatype

boolean

Alias
UMLS CUI [1]
C1335701
UMLS CUI [2,1]
C1335723
UMLS CUI [2,2]
C0205225
UMLS CUI [3,1]
C4040298
UMLS CUI [3,2]
C0205250
large cell transformation of lymphoma from a more indolent lymphoma (e.g., follicular, marginal zone, etc.)
Beschrijving

Indolent lymphoma | Lymphoma, Follicular | Marginal zone lymphoma | Lymphoma transformation | Large cell lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C1334170
UMLS CUI [2]
C0024301
UMLS CUI [3]
C0242647
UMLS CUI [4]
C1536010
UMLS CUI [5]
C0024302
mantle cell lymphoma that is:
Beschrijving

Mantle cell lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C0334634
primary refractory (achievement less than complete response)
Beschrijving

Primary Refractory | Complete response Less Than

Datatype

boolean

Alias
UMLS CUI [1]
C2347678
UMLS CUI [2,1]
C0677874
UMLS CUI [2,2]
C0439092
relapsed (regardless of chemosensitivity of relapsed disease)
Beschrijving

Recurrent disease | Chemosensitivity Independent of

Datatype

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2,1]
C2347610
UMLS CUI [2,2]
C0332291
2. patients who received prior autologous stem cell transplantation are not eligible.
Beschrijving

Transplantation of autologous hematopoietic stem cell Exclusion

Datatype

boolean

Alias
UMLS CUI [1,1]
C1831743
UMLS CUI [1,2]
C2828389
3. patient age 18-70 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
4. performance status ecog 0-1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
5. required baseline laboratory values:
Beschrijving

Laboratory Results Patient need for

Datatype

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0686904
lvef > 45% corrected
Beschrijving

Left ventricular ejection fraction Corrected

Datatype

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0205202
dlco > 50% of predicted value (corrected for hemoglobin)
Beschrijving

Carbon Monoxide Diffusing Capability Test | Hemoglobin measurement Corrected

Datatype

boolean

Alias
UMLS CUI [1]
C1516251
UMLS CUI [2,1]
C0518015
UMLS CUI [2,2]
C0205202
serum creatinine ≤ 2.0 mg/dl or estimated creatinine clearance of ≥60 ml/min
Beschrijving

Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C2711451
bilirubin < 1 x upper limit of normal value.
Beschrijving

Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
ast and alt < 1 x upper limit of normal value.
Beschrijving

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
6. signed written informed consent. patient must be capable of understanding the investigational nature of the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. no active infection. patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection.
Beschrijving

Communicable Disease | Antibiotics Oral Patient need for | Antibiotics Intravenous Patient need for

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0003232
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0686904
UMLS CUI [3,1]
C0003232
UMLS CUI [3,2]
C1522726
UMLS CUI [3,3]
C0686904
2. no hiv disease. patients with immune dysfunction are at a significantly higher risk of infection from intensive immunosuppressive therapies.
Beschrijving

HIV Infection | Immune System Disease High risk of Infection | Therapeutic immunosuppression intense Causing Infection

Datatype

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2,1]
C0021053
UMLS CUI [2,2]
C0332167
UMLS CUI [2,3]
C3714514
UMLS CUI [3,1]
C0021079
UMLS CUI [3,2]
C0522510
UMLS CUI [3,3]
C0678227
UMLS CUI [3,4]
C3714514
3. non-pregnant and non-nursing. treatment under this protocol would expose a fetus to significant risks. women of childbearing potential should have a negative pregnancy test prior to study entry. women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. appropriate methods of birth control include oral contraceptives, implantable hormonal contraceptives (norplant®), or double barrier method (diaphragm plus condom).
Beschrijving

Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Reproductive potential Contraceptive methods | Contraceptives, Oral | Hormonal contraception | CONTRACEPTION NORPLANT | Barrier Contraception Double | Vaginal contraceptive diaphragm | Condom

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0427780
UMLS CUI [4,1]
C4034483
UMLS CUI [4,2]
C0700589
UMLS CUI [5]
C0009905
UMLS CUI [6]
C2985296
UMLS CUI [7]
C0742782
UMLS CUI [8,1]
C0004764
UMLS CUI [8,2]
C0205173
UMLS CUI [9]
C0042241
UMLS CUI [10]
C0677582
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Similar models

Eligibility Non Hodgkin's Lymphoma NCT00477945

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
types of diseases
Item
1. documentation of disease. patients must have one of the following disease types:
boolean
C0457464 (UMLS CUI [1])
Diffuse Large B-Cell Lymphoma | Mediastinal (Thymic) Large B-Cell Lymphoma | Peripheral T-Cell Lymphoma
Item
diffuse large cell non-hodgkin's lymphoma, mediastinal b-cell lymphoma, or peripheral t-cell lymphoma that is:
boolean
C0079744 (UMLS CUI [1])
C1292754 (UMLS CUI [2])
C0079774 (UMLS CUI [3])
Primary Refractory | Complete response Less Than
Item
primary refractory (achievement less than complete response)
boolean
C2347678 (UMLS CUI [1])
C0677874 (UMLS CUI [2,1])
C0439092 (UMLS CUI [2,2])
Salvage Therapy Quantity Recurrent disease | Salvage Therapy Quantity Refractory | Partial response Less Than
Item
relapsed and refractory (achievement less than a partial response) to at least a single salvage therapy
boolean
C0085405 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,3])
C0085405 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0205269 (UMLS CUI [2,3])
C1521726 (UMLS CUI [3,1])
C0439092 (UMLS CUI [3,2])
Recurrent Follicular Lymphoma | Refractory Follicular Lymphoma Primary | Follicular Lymphoma International Prognostic Index High
Item
relapsed or primary refractory follicular lymphoma (fl) with a high fl international prognostic index.
boolean
C1335701 (UMLS CUI [1])
C1335723 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C4040298 (UMLS CUI [3,1])
C0205250 (UMLS CUI [3,2])
Indolent lymphoma | Lymphoma, Follicular | Marginal zone lymphoma | Lymphoma transformation | Large cell lymphoma
Item
large cell transformation of lymphoma from a more indolent lymphoma (e.g., follicular, marginal zone, etc.)
boolean
C1334170 (UMLS CUI [1])
C0024301 (UMLS CUI [2])
C0242647 (UMLS CUI [3])
C1536010 (UMLS CUI [4])
C0024302 (UMLS CUI [5])
Mantle cell lymphoma
Item
mantle cell lymphoma that is:
boolean
C0334634 (UMLS CUI [1])
Primary Refractory | Complete response Less Than
Item
primary refractory (achievement less than complete response)
boolean
C2347678 (UMLS CUI [1])
C0677874 (UMLS CUI [2,1])
C0439092 (UMLS CUI [2,2])
Recurrent disease | Chemosensitivity Independent of
Item
relapsed (regardless of chemosensitivity of relapsed disease)
boolean
C0277556 (UMLS CUI [1])
C2347610 (UMLS CUI [2,1])
C0332291 (UMLS CUI [2,2])
Transplantation of autologous hematopoietic stem cell Exclusion
Item
2. patients who received prior autologous stem cell transplantation are not eligible.
boolean
C1831743 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Age
Item
3. patient age 18-70 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
4. performance status ecog 0-1
boolean
C1520224 (UMLS CUI [1])
Laboratory Results Patient need for
Item
5. required baseline laboratory values:
boolean
C1254595 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
Left ventricular ejection fraction Corrected
Item
lvef > 45% corrected
boolean
C0428772 (UMLS CUI [1,1])
C0205202 (UMLS CUI [1,2])
Carbon Monoxide Diffusing Capability Test | Hemoglobin measurement Corrected
Item
dlco > 50% of predicted value (corrected for hemoglobin)
boolean
C1516251 (UMLS CUI [1])
C0518015 (UMLS CUI [2,1])
C0205202 (UMLS CUI [2,2])
Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
serum creatinine ≤ 2.0 mg/dl or estimated creatinine clearance of ≥60 ml/min
boolean
C0201976 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Serum total bilirubin measurement
Item
bilirubin < 1 x upper limit of normal value.
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast and alt < 1 x upper limit of normal value.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Informed Consent
Item
6. signed written informed consent. patient must be capable of understanding the investigational nature of the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Communicable Disease | Antibiotics Oral Patient need for | Antibiotics Intravenous Patient need for
Item
1. no active infection. patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection.
boolean
C0009450 (UMLS CUI [1])
C0003232 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
C0003232 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
C0686904 (UMLS CUI [3,3])
HIV Infection | Immune System Disease High risk of Infection | Therapeutic immunosuppression intense Causing Infection
Item
2. no hiv disease. patients with immune dysfunction are at a significantly higher risk of infection from intensive immunosuppressive therapies.
boolean
C0019693 (UMLS CUI [1])
C0021053 (UMLS CUI [2,1])
C0332167 (UMLS CUI [2,2])
C3714514 (UMLS CUI [2,3])
C0021079 (UMLS CUI [3,1])
C0522510 (UMLS CUI [3,2])
C0678227 (UMLS CUI [3,3])
C3714514 (UMLS CUI [3,4])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Reproductive potential Contraceptive methods | Contraceptives, Oral | Hormonal contraception | CONTRACEPTION NORPLANT | Barrier Contraception Double | Vaginal contraceptive diaphragm | Condom
Item
3. non-pregnant and non-nursing. treatment under this protocol would expose a fetus to significant risks. women of childbearing potential should have a negative pregnancy test prior to study entry. women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. appropriate methods of birth control include oral contraceptives, implantable hormonal contraceptives (norplant®), or double barrier method (diaphragm plus condom).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C4034483 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0009905 (UMLS CUI [5])
C2985296 (UMLS CUI [6])
C0742782 (UMLS CUI [7])
C0004764 (UMLS CUI [8,1])
C0205173 (UMLS CUI [8,2])
C0042241 (UMLS CUI [9])
C0677582 (UMLS CUI [10])
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