ID

24749

Description

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

Link

https://clinicaltrials.gov/show/NCT00644371

Keywords

Versions (1)
  1. 8/16/17 8/16/17 -
Uploaded on

August 16, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

No comments

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Non-Hodgkin Lymphoma NCT00644371

English

Eligibility Non-Hodgkin Lymphoma NCT00644371

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. written informed consent
Description

Informed Consent

Data type

boolean

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

B-Cell Lymphoma Subtype

Data type

boolean

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

Diffuse Large B-Cell Lymphoma

Data type

boolean

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

Follicular Lymphoma Ann Arbor lymphoma staging system

Data type

boolean

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

Mantle-cell lymphoma

Data type

boolean

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

B-Cell Lymphoma Transformation

Data type

boolean

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

Burkitt Lymphoma | Patient Inappropriate Allogeneic Transplantation

Data type

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
Description

B-Cell Lymphoma CD20 positive High risk of

Data type

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
Description

Chemotherapy cycle Quantity | Partial response Less Than

Data type

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
Description

Recurrent disease Post Transplantation

Data type

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
Description

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

Data type

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
Description

Transplantation, Autologous | Stem cell Collection Unable

Data type

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
Description

Stable Disease

Data type

boolean

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

Age

Data type

boolean

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

ECOG performance status

Data type

boolean

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

Pulmonary function | Carbon Monoxide Diffusing Capability Test

Data type

boolean

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

Left ventricular ejection fraction Ventriculography | Left ventricular ejection fraction Echocardiography

Data type

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)
Description

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

Data type

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
Description

Exclusion Criteria

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

Radiopharmaceuticals

Data type

boolean

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

Lymphoma, HIV-Related

Data type

boolean

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

Human anti-mouse antibody | Human antichimeric Ab

Data type

boolean

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

Protocol Compliance Unable

Data type

boolean

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

Hypersensitivity yttrium-90-ibritumomab tiuxetan

Data type

boolean

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

Pathology Severe Excludes Chemotherapy

Data type

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
Description

Pregnancy | Contraceptive methods Inappropriate | Pregnancy Risk

Data type

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
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
Back to the top of the page

Similar models

Eligibility Non-Hodgkin Lymphoma NCT00644371

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial