ID

31071

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00463463

Nyckelord

Versioner (1)
  1. 2018-07-17 2018-07-17 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

17 juli 2018

DOI

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Creative Commons BY 4.0
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Eligibility Non-Hodgkin's Lymphoma NCT00463463

Engelsk

Eligibility Non-Hodgkin's Lymphoma NCT00463463

1 Formulär  
Inclusion Criteria
Beskrivning

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.
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Chemosensitive malignant neoplastic disease | Partial response Salvage Chemotherapy

Datatyp

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.
Beskrivning

Line of Therapy Quantity | Induction Therapy | Salvage Therapy

Datatyp

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.
Beskrivning

Age

Datatyp

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.
Beskrivning

Stem cell collection Autologous Transplantation

Datatyp

boolean

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

Informed Consent

Datatyp

boolean

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

Fertility Contraceptive methods

Datatyp

boolean

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

Prior Chemotherapy Completed

Datatyp

boolean

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

Exclusion Criteria

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

Chemotherapy Refractory Disease | Prior Therapy Quantity

Datatyp

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
Beskrivning

Serum total bilirubin measurement | Serum transaminase increased

Datatyp

boolean

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

Creatinine measurement, serum

Datatyp

boolean

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

ECOG performance status

Datatyp

boolean

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

Communicable Disease Uncontrolled

Datatyp

boolean

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

Pregnancy | Breast Feeding

Datatyp

boolean

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

Abnormal DLCO

Datatyp

boolean

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

Cardiovascular Disease Severe

Datatyp

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.
Beskrivning

Chemotherapy Refractory Disease | Partial response failed Salvage Chemotherapy

Datatyp

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
Beskrivning

CNS disorder Involvement

Datatyp

boolean

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

Pleural effusion | Ascites

Datatyp

boolean

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

Hypersensitivity Rituximab

Datatyp

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
Beskrivning

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

Datatyp

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
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Similar models

Eligibility Non-Hodgkin's Lymphoma NCT00463463

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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