ID

31071

Beschrijving

Zevalin and BEAM High-dose Chemotherapy Compared With BEAM Alone as Conditioning Regimen in Patients With Chemosensitive Relapse of Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00463463

Link

https://clinicaltrials.gov/show/NCT00463463

Trefwoorden

Versies (1)
  1. 17-07-18 17-07-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

17 juli 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Non-Hodgkin's Lymphoma NCT00463463

Engels

Eligibility Non-Hodgkin's Lymphoma NCT00463463

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with cd20 positive aggressive non-hodgkin's lymphoma, either diffuse large b-cell or transformed follicular lymphoma as confirmed by a pathological biopsy report.
Beschrijving

Aggressive Non-Hodgkin Lymphoma CD20 positive | Diffuse Large B-Cell Lymphoma | Transformation Follicular Lymphoma | Pathology biopsy report

Datatype

boolean

Alias
UMLS CUI [1,1]
C1332225
UMLS CUI [1,2]
C3888518
UMLS CUI [2]
C0079744
UMLS CUI [3,1]
C0040682
UMLS CUI [3,2]
C0024301
UMLS CUI [4]
C3165547
2. patients who are candidates for stem-cell transplantation due to refractory disease to first line chemotherapy or relapsing disease and comply with standard transplant eligibility criteria.
Beschrijving

Stem cell transplantation Anticipated | First line Chemotherapy Refractory Disease | Recurrent disease | Transplantation Eligibility Criteria Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C1504389
UMLS CUI [1,2]
C3840775
UMLS CUI [2,1]
C1708063
UMLS CUI [2,2]
C0392920
UMLS CUI [2,3]
C1514815
UMLS CUI [3]
C0277556
UMLS CUI [4,1]
C0040732
UMLS CUI [4,2]
C1516637
UMLS CUI [4,3]
C1550543
3. patients must have chemo-sensitive disease achieving at least partial response to salvage chemotherapy.
Beschrijving

Chemosensitive malignant neoplastic disease | Partial response Salvage Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C4520514
UMLS CUI [2,1]
C1521726
UMLS CUI [2,2]
C0085405
UMLS CUI [2,3]
C0392920
4. patients were given up to 2 lines of therapy, initial treatment and one salvage treatment. local radiation therapy for consolidation is not considered a line of therapy.
Beschrijving

Line of Therapy Quantity | Induction Therapy | Salvage Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C4524693
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0600558
UMLS CUI [3]
C0085405
5. age less than physiologic 65 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
6. patients with an adequate autologous stem cell collection for transplantation (>2.5 x 106 cd34+ cells/kg). backup collection is preferable but not obligatory.
Beschrijving

Stem cell collection Autologous Transplantation

Datatype

boolean

Alias
UMLS CUI [1,1]
C3827940
UMLS CUI [1,2]
C0439859
UMLS CUI [1,3]
C0040732
7. patients must sign written informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
8. adequate birth control in fertile patients.
Beschrijving

Fertility Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
9. all prior chemotherapy completed at least three weeks before study treatment
Beschrijving

Prior Chemotherapy Completed

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0205197
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. chemo-refractory disease or more than 2 prior therapies
Beschrijving

Chemotherapy Refractory Disease | Prior Therapy Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1514815
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C1265611
2. bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit
Beschrijving

Serum total bilirubin measurement | Serum transaminase increased

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0859350
3. creatinine > 2.0 mg/dl
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
4. ecog-performance status < 2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
5. uncontrolled infection
Beschrijving

Communicable Disease Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
6. pregnancy or lactation
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
7. abnormal lung diffusion capacity (dlco < 40% predicted)
Beschrijving

Abnormal DLCO

Datatype

boolean

Alias
UMLS CUI [1]
C4073173
8. severe cardiovascular disease
Beschrijving

Cardiovascular Disease Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205082
9. chemo-refractory disease as determined by less than partial response to salvage chemotherapy.
Beschrijving

Chemotherapy Refractory Disease | Partial response failed Salvage Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1514815
UMLS CUI [2,1]
C1521726
UMLS CUI [2,2]
C0231175
UMLS CUI [2,3]
C0085405
UMLS CUI [2,4]
C0392920
10. active cns disease involvement
Beschrijving

CNS disorder Involvement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007682
UMLS CUI [1,2]
C1314939
11. pleural effusion or ascites > 1 liter
Beschrijving

Pleural effusion | Ascites

Datatype

boolean

Alias
UMLS CUI [1]
C0032227
UMLS CUI [2]
C0003962
12. known hypersensitivity to rituximab
Beschrijving

Hypersensitivity Rituximab

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0393022
13. psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate
Beschrijving

Mental condition Impairing Informed Consent | Mental disorders Impairing Informed Consent | Mental condition Impairing Compliance behavior | Mental disorders Impairing Compliance behavior

Datatype

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C0221099
UMLS CUI [3,3]
C1321605
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0221099
UMLS CUI [4,3]
C1321605
Terug naar het begin van de pagina

Similar models

Eligibility Non-Hodgkin's Lymphoma NCT00463463

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Aggressive Non-Hodgkin Lymphoma CD20 positive | Diffuse Large B-Cell Lymphoma | Transformation Follicular Lymphoma | Pathology biopsy report
Item
1. patients with cd20 positive aggressive non-hodgkin's lymphoma, either diffuse large b-cell or transformed follicular lymphoma as confirmed by a pathological biopsy report.
boolean
C1332225 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])
C0079744 (UMLS CUI [2])
C0040682 (UMLS CUI [3,1])
C0024301 (UMLS CUI [3,2])
C3165547 (UMLS CUI [4])
Stem cell transplantation Anticipated | First line Chemotherapy Refractory Disease | Recurrent disease | Transplantation Eligibility Criteria Fulfill
Item
2. patients who are candidates for stem-cell transplantation due to refractory disease to first line chemotherapy or relapsing disease and comply with standard transplant eligibility criteria.
boolean
C1504389 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
C1708063 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C1514815 (UMLS CUI [2,3])
C0277556 (UMLS CUI [3])
C0040732 (UMLS CUI [4,1])
C1516637 (UMLS CUI [4,2])
C1550543 (UMLS CUI [4,3])
Chemosensitive malignant neoplastic disease | Partial response Salvage Chemotherapy
Item
3. patients must have chemo-sensitive disease achieving at least partial response to salvage chemotherapy.
boolean
C4520514 (UMLS CUI [1])
C1521726 (UMLS CUI [2,1])
C0085405 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
Line of Therapy Quantity | Induction Therapy | Salvage Therapy
Item
4. patients were given up to 2 lines of therapy, initial treatment and one salvage treatment. local radiation therapy for consolidation is not considered a line of therapy.
boolean
C4524693 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0600558 (UMLS CUI [2])
C0085405 (UMLS CUI [3])
Age
Item
5. age less than physiologic 65 years.
boolean
C0001779 (UMLS CUI [1])
Stem cell collection Autologous Transplantation
Item
6. patients with an adequate autologous stem cell collection for transplantation (>2.5 x 106 cd34+ cells/kg). backup collection is preferable but not obligatory.
boolean
C3827940 (UMLS CUI [1,1])
C0439859 (UMLS CUI [1,2])
C0040732 (UMLS CUI [1,3])
Informed Consent
Item
7. patients must sign written informed consent.
boolean
C0021430 (UMLS CUI [1])
Fertility Contraceptive methods
Item
8. adequate birth control in fertile patients.
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Prior Chemotherapy Completed
Item
9. all prior chemotherapy completed at least three weeks before study treatment
boolean
C1514457 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Refractory Disease | Prior Therapy Quantity
Item
1. chemo-refractory disease or more than 2 prior therapies
boolean
C0392920 (UMLS CUI [1,1])
C1514815 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Serum total bilirubin measurement | Serum transaminase increased
Item
2. bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit
boolean
C1278039 (UMLS CUI [1])
C0859350 (UMLS CUI [2])
Creatinine measurement, serum
Item
3. creatinine > 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
ECOG performance status
Item
4. ecog-performance status < 2
boolean
C1520224 (UMLS CUI [1])
Communicable Disease Uncontrolled
Item
5. uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
6. pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Abnormal DLCO
Item
7. abnormal lung diffusion capacity (dlco < 40% predicted)
boolean
C4073173 (UMLS CUI [1])
Cardiovascular Disease Severe
Item
8. severe cardiovascular disease
boolean
C0007222 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Chemotherapy Refractory Disease | Partial response failed Salvage Chemotherapy
Item
9. chemo-refractory disease as determined by less than partial response to salvage chemotherapy.
boolean
C0392920 (UMLS CUI [1,1])
C1514815 (UMLS CUI [1,2])
C1521726 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0085405 (UMLS CUI [2,3])
C0392920 (UMLS CUI [2,4])
CNS disorder Involvement
Item
10. active cns disease involvement
boolean
C0007682 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
Pleural effusion | Ascites
Item
11. pleural effusion or ascites > 1 liter
boolean
C0032227 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
Hypersensitivity Rituximab
Item
12. known hypersensitivity to rituximab
boolean
C0020517 (UMLS CUI [1,1])
C0393022 (UMLS CUI [1,2])
Mental condition Impairing Informed Consent | Mental disorders Impairing Informed Consent | Mental condition Impairing Compliance behavior | Mental disorders Impairing Compliance behavior
Item
13. psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate
boolean
C3840291 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C0221099 (UMLS CUI [3,2])
C1321605 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C0221099 (UMLS CUI [4,2])
C1321605 (UMLS CUI [4,3])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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