ID

24749

Beskrivning

Allogenic Stem Cell Transplantation (SCT) With Non-Myeloablative Conditioning in Patients With Relapse Non-Hodgkin's Lymphoma (NHL); ODM derived from: https://clinicaltrials.gov/show/NCT00644371

Länk

https://clinicaltrials.gov/show/NCT00644371

Nyckelord

Versioner (1)
  1. 2017-08-16 2017-08-16 -
Uppladdad den

16 augusti 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non-Hodgkin Lymphoma NCT00644371

Engelsk

Eligibility Non-Hodgkin Lymphoma NCT00644371

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
2. histologically confirmed b-cell lymphoma of the following subtypes:
Beskrivning

B-Cell Lymphoma Subtype

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079731
UMLS CUI [1,2]
C0449560
lbcdl
Beskrivning

Diffuse Large B-Cell Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0079744
grade 3b follicular lymphoma
Beskrivning

Follicular Lymphoma Ann Arbor lymphoma staging system

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0432516
mantle-cell lymphoma
Beskrivning

Mantle-cell lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0334634
transformed b-cell lymphoma
Beskrivning

B-Cell Lymphoma Transformation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079731
UMLS CUI [1,2]
C1536010
burkitt lymphoma in patients not eligible for a conventional allogeneic transplant
Beskrivning

Burkitt Lymphoma | Patient Inappropriate Allogeneic Transplantation

Datatyp

boolean

Alias
UMLS CUI [1]
C0006413
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0040739
3. high-risk b-cell cd20+ lymphoma defined by
Beskrivning

B-Cell Lymphoma CD20 positive High risk of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079731
UMLS CUI [1,2]
C0882818
UMLS CUI [1,3]
C0332167
having attained less than pr after two chemotherapy lines
Beskrivning

Chemotherapy cycle Quantity | Partial response Less Than

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1521726
UMLS CUI [2,2]
C0439092
post-transplantation relapse
Beskrivning

Recurrent disease Post Transplantation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0040732
presence of disease detected through a metabolic approach (pet/ct or else ct+pet) either before or after autologous transplantation
Beskrivning

Disease detection PET/CT Before Autologous Transplantation | Disease detection CT Before Autologous Transplantation | Disease detection PET Before Autologous Transplantation | Disease detection PET/CT Post Autologous Transplantation | Disease detection CT Post Autologous Transplantation | Disease detection PET Post Autologous Transplantation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0683509
UMLS CUI [1,2]
C1699633
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0040736
UMLS CUI [2,1]
C0683509
UMLS CUI [2,2]
C0040405
UMLS CUI [2,3]
C0332152
UMLS CUI [2,4]
C0040736
UMLS CUI [3,1]
C0683509
UMLS CUI [3,2]
C0032743
UMLS CUI [3,3]
C0332152
UMLS CUI [3,4]
C0040736
UMLS CUI [4,1]
C0683509
UMLS CUI [4,2]
C1699633
UMLS CUI [4,3]
C0687676
UMLS CUI [4,4]
C0040736
UMLS CUI [5,1]
C0683509
UMLS CUI [5,2]
C0040405
UMLS CUI [5,3]
C0687676
UMLS CUI [5,4]
C0040736
UMLS CUI [6,1]
C0683509
UMLS CUI [6,2]
C0032743
UMLS CUI [6,3]
C0687676
UMLS CUI [6,4]
C0040736
inability to collect enough stem cells for autologous transplantation
Beskrivning

Transplantation, Autologous | Stem cell Collection Unable

Datatyp

boolean

Alias
UMLS CUI [1]
C0040736
UMLS CUI [2,1]
C0038250
UMLS CUI [2,2]
C1516698
UMLS CUI [2,3]
C1299582
4. stable disease at the time of transplantation
Beskrivning

Stable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0677946
5. age between 18 and 65
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
6. performance status (ecog) ≤ 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
7. normal and suitable pulmonary function (dlco ≥ 30%)
Beskrivning

Pulmonary function | Carbon Monoxide Diffusing Capability Test

Datatyp

boolean

Alias
UMLS CUI [1]
C0231921
UMLS CUI [2]
C1516251
8. left ventricular ejection fraction (lvef) determined by ventriculography or echocardiogram ≥ 40%
Beskrivning

Left ventricular ejection fraction Ventriculography | Left ventricular ejection fraction Echocardiography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0596683
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0013516
9. normal hepatic and renal function, with creatinine ≤ 2 mg/dl and bi ≤ 1.5 mg/dl, and alkaline phosphatase ≤ 2.5 x unl ; ast, alt ≤ 2.5 x unl (≤ 5 x unl if hepatic infiltration)
Beskrivning

Liver function | Renal function | Creatinine measurement, serum | Serum total bilirubin measurement | Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Infiltration Hepatic

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0201976
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0201850
UMLS CUI [6]
C0201899
UMLS CUI [7]
C0201836
UMLS CUI [8,1]
C0332448
UMLS CUI [8,2]
C0205054
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior treatment with radiopharmaceutical agents
Beskrivning

Radiopharmaceuticals

Datatyp

boolean

Alias
UMLS CUI [1]
C0182638
2. hiv-associated lymphoma
Beskrivning

Lymphoma, HIV-Related

Datatyp

boolean

Alias
UMLS CUI [1]
C0085090
3. presence of human anti-mouse antibodies (hama) or anti-chimeric antibodies (haca)
Beskrivning

Human anti-mouse antibody | Human antichimeric Ab

Datatyp

boolean

Alias
UMLS CUI [1]
C1291910
UMLS CUI [2]
C1317433
4. patient's inability to follow the protocol
Beskrivning

Protocol Compliance Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
5. hypersensitivity to 90y-itritumomab tiuxetan
Beskrivning

Hypersensitivity yttrium-90-ibritumomab tiuxetan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1134535
6. presence of severe pathologies that preclude chemotherapeutic treatment
Beskrivning

Pathology Severe Excludes Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677042
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332196
UMLS CUI [1,4]
C0392920
7. pregnant women or pregnancy risk due to inappropriate contraceptive measures
Beskrivning

Pregnancy | Contraceptive methods Inappropriate | Pregnancy Risk

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C1548788
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C0035647
8. breastfeeding women
Beskrivning

Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0006147
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Similar models

Eligibility Non-Hodgkin Lymphoma NCT00644371

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. written informed consent
boolean
C0021430 (UMLS CUI [1])
B-Cell Lymphoma Subtype
Item
2. histologically confirmed b-cell lymphoma of the following subtypes:
boolean
C0079731 (UMLS CUI [1,1])
C0449560 (UMLS CUI [1,2])
Diffuse Large B-Cell Lymphoma
Item
lbcdl
boolean
C0079744 (UMLS CUI [1])
Follicular Lymphoma Ann Arbor lymphoma staging system
Item
grade 3b follicular lymphoma
boolean
C0024301 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
Mantle-cell lymphoma
Item
mantle-cell lymphoma
boolean
C0334634 (UMLS CUI [1])
B-Cell Lymphoma Transformation
Item
transformed b-cell lymphoma
boolean
C0079731 (UMLS CUI [1,1])
C1536010 (UMLS CUI [1,2])
Burkitt Lymphoma | Patient Inappropriate Allogeneic Transplantation
Item
burkitt lymphoma in patients not eligible for a conventional allogeneic transplant
boolean
C0006413 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0040739 (UMLS CUI [2,3])
B-Cell Lymphoma CD20 positive High risk of
Item
3. high-risk b-cell cd20+ lymphoma defined by
boolean
C0079731 (UMLS CUI [1,1])
C0882818 (UMLS CUI [1,2])
C0332167 (UMLS CUI [1,3])
Chemotherapy cycle Quantity | Partial response Less Than
Item
having attained less than pr after two chemotherapy lines
boolean
C1302181 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1521726 (UMLS CUI [2,1])
C0439092 (UMLS CUI [2,2])
Recurrent disease Post Transplantation
Item
post-transplantation relapse
boolean
C0277556 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0040732 (UMLS CUI [1,3])
Disease detection PET/CT Before Autologous Transplantation | Disease detection CT Before Autologous Transplantation | Disease detection PET Before Autologous Transplantation | Disease detection PET/CT Post Autologous Transplantation | Disease detection CT Post Autologous Transplantation | Disease detection PET Post Autologous Transplantation
Item
presence of disease detected through a metabolic approach (pet/ct or else ct+pet) either before or after autologous transplantation
boolean
C0683509 (UMLS CUI [1,1])
C1699633 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0040736 (UMLS CUI [1,4])
C0683509 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C0040736 (UMLS CUI [2,4])
C0683509 (UMLS CUI [3,1])
C0032743 (UMLS CUI [3,2])
C0332152 (UMLS CUI [3,3])
C0040736 (UMLS CUI [3,4])
C0683509 (UMLS CUI [4,1])
C1699633 (UMLS CUI [4,2])
C0687676 (UMLS CUI [4,3])
C0040736 (UMLS CUI [4,4])
C0683509 (UMLS CUI [5,1])
C0040405 (UMLS CUI [5,2])
C0687676 (UMLS CUI [5,3])
C0040736 (UMLS CUI [5,4])
C0683509 (UMLS CUI [6,1])
C0032743 (UMLS CUI [6,2])
C0687676 (UMLS CUI [6,3])
C0040736 (UMLS CUI [6,4])
Transplantation, Autologous | Stem cell Collection Unable
Item
inability to collect enough stem cells for autologous transplantation
boolean
C0040736 (UMLS CUI [1])
C0038250 (UMLS CUI [2,1])
C1516698 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Stable Disease
Item
4. stable disease at the time of transplantation
boolean
C0677946 (UMLS CUI [1])
Age
Item
5. age between 18 and 65
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
6. performance status (ecog) ≤ 2
boolean
C1520224 (UMLS CUI [1])
Pulmonary function | Carbon Monoxide Diffusing Capability Test
Item
7. normal and suitable pulmonary function (dlco ≥ 30%)
boolean
C0231921 (UMLS CUI [1])
C1516251 (UMLS CUI [2])
Left ventricular ejection fraction Ventriculography | Left ventricular ejection fraction Echocardiography
Item
8. left ventricular ejection fraction (lvef) determined by ventriculography or echocardiogram ≥ 40%
boolean
C0428772 (UMLS CUI [1,1])
C0596683 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Liver function | Renal function | Creatinine measurement, serum | Serum total bilirubin measurement | Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Infiltration Hepatic
Item
9. normal hepatic and renal function, with creatinine ≤ 2 mg/dl and bi ≤ 1.5 mg/dl, and alkaline phosphatase ≤ 2.5 x unl ; ast, alt ≤ 2.5 x unl (≤ 5 x unl if hepatic infiltration)
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201850 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201836 (UMLS CUI [7])
C0332448 (UMLS CUI [8,1])
C0205054 (UMLS CUI [8,2])
Item Group
C0680251 (UMLS CUI)
Radiopharmaceuticals
Item
1. prior treatment with radiopharmaceutical agents
boolean
C0182638 (UMLS CUI [1])
Lymphoma, HIV-Related
Item
2. hiv-associated lymphoma
boolean
C0085090 (UMLS CUI [1])
Human anti-mouse antibody | Human antichimeric Ab
Item
3. presence of human anti-mouse antibodies (hama) or anti-chimeric antibodies (haca)
boolean
C1291910 (UMLS CUI [1])
C1317433 (UMLS CUI [2])
Protocol Compliance Unable
Item
4. patient's inability to follow the protocol
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Hypersensitivity yttrium-90-ibritumomab tiuxetan
Item
5. hypersensitivity to 90y-itritumomab tiuxetan
boolean
C0020517 (UMLS CUI [1,1])
C1134535 (UMLS CUI [1,2])
Pathology Severe Excludes Chemotherapy
Item
6. presence of severe pathologies that preclude chemotherapeutic treatment
boolean
C0677042 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0392920 (UMLS CUI [1,4])
Pregnancy | Contraceptive methods Inappropriate | Pregnancy Risk
Item
7. pregnant women or pregnancy risk due to inappropriate contraceptive measures
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0032961 (UMLS CUI [3,1])
C0035647 (UMLS CUI [3,2])
Breast Feeding
Item
8. breastfeeding women
boolean
C0006147 (UMLS CUI [1])
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