ID

41250

Descripción

Allogeneic Hematopoietic Stem Cell Transplantation After Reduced-intensity Conditioning for Relapsed Follicular Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01208896

Link

https://clinicaltrials.gov/show/NCT01208896

Palabras clave

Versiones (1)
  1. 24/7/20 24/7/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

24 de julio de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Lymphoma, Follicular NCT01208896

Inglés

Eligibility Lymphoma, Follicular NCT01208896

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18 and ≤ 65 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
follicular lymphoma confirmed by a biopsy at the last relapse.
Descripción

Lymphoma, Follicular | Recurrent disease | Biopsy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0024301
UMLS CUI [2]
C0277556
UMLS CUI [3]
C0005558
2nd, 3rd or 4th complete or partial response according to cheson's criteria 1 (annexe 1)
Descripción

In complete remission | partial response

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0677874
UMLS CUI [2]
C1521726
relapse after autologous-sct except if the absence of autologous sct is due to a failure of collecting peripheral stem cells or investigator decision to not proceed to the autologous graft because of serious criteria
Descripción

Recurrent disease Post Autologous hematopoietic stem cell transplant

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C2193200
relapse after at least one line of treatment with rituximab
Descripción

Recurrent disease | rituximab

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C0393022
karnofsky index > 70%
Descripción

Karnofsky Performance Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0206065
hla matched related or unrelated donor (10/10 matching; hla-a, hla-b, hla-c, hla-drb1, hla-dqb1)
Descripción

HLA Match Living related donor | HLA Match Unrelated Donor | Matching HLA-A | Matching HLA-B | Matching HLA-C | Matching HLA-DRB1 | Matching HLA-DQB1

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4330149
UMLS CUI [1,2]
C3494891
UMLS CUI [2,1]
C4330149
UMLS CUI [2,2]
C3179133
UMLS CUI [3,1]
C1708943
UMLS CUI [3,2]
C0019728
UMLS CUI [4,1]
C1708943
UMLS CUI [4,2]
C0019737
UMLS CUI [5,1]
C1708943
UMLS CUI [5,2]
C0019751
UMLS CUI [6,1]
C1708943
UMLS CUI [6,2]
C0122040
UMLS CUI [7,1]
C1708943
UMLS CUI [7,2]
C0122020
signed informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
stable or progressive disease according to cheson's criteria1 (annexe 1)
Descripción

Stable Disease | Progressive Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0677946
UMLS CUI [2]
C1335499
absence of treatment with rituximab before the last relapse
Descripción

Rituximab Absent | Status pre- Relapse

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0393022
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0035020
cardiac insufficiency (ejection fraction < 50% by echocardiography)
Descripción

Heart failure | Cardiac ejection fraction Echocardiography

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2,1]
C0232174
UMLS CUI [2,2]
C0013516
pulmonary disease characterized by dlco < 60%
Descripción

Lung disease | Carbon Monoxide Diffusing Capability Test

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2]
C1516251
renal insufficiency (clearance of creatinin < 60 ml/min)
Descripción

Renal Insufficiency | Creatinine clearance measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0373595
hepatic disease characterized by asat and/or alat and/or total bilirubin > 2 times the upper normal value except in case of gilbert's disease or hepatic lymphoma
Descripción

Liver diseases | Aspartate Aminotransferase Increased | Alanine Aminotransferase Increased | Elevated total bilirubin | Exception Gilbert Disease | Exception Hepatic lymphoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0741494
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0017551
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1112746
hiv positive test
Descripción

HIV Seropositivity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019699
bacterial, viral or fungal uncontrolled infections
Descripción

Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0042769
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0026946
UMLS CUI [3,2]
C0205318
pregnant or breast feeding woman
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
cancer in the last 5 years except in case of cutaneous baso-cellular cancer or epithelioma "in situ" of the uterine cervix
Descripción

Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
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Similar models

Eligibility Lymphoma, Follicular NCT01208896

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥ 18 and ≤ 65 years
boolean
C0001779 (UMLS CUI [1])
Lymphoma, Follicular | Recurrent disease | Biopsy
Item
follicular lymphoma confirmed by a biopsy at the last relapse.
boolean
C0024301 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C0005558 (UMLS CUI [3])
In complete remission | partial response
Item
2nd, 3rd or 4th complete or partial response according to cheson's criteria 1 (annexe 1)
boolean
C0677874 (UMLS CUI [1])
C1521726 (UMLS CUI [2])
Recurrent disease Post Autologous hematopoietic stem cell transplant
Item
relapse after autologous-sct except if the absence of autologous sct is due to a failure of collecting peripheral stem cells or investigator decision to not proceed to the autologous graft because of serious criteria
boolean
C0277556 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C2193200 (UMLS CUI [1,3])
Recurrent disease | rituximab
Item
relapse after at least one line of treatment with rituximab
boolean
C0277556 (UMLS CUI [1])
C0393022 (UMLS CUI [2])
Karnofsky Performance Status
Item
karnofsky index > 70%
boolean
C0206065 (UMLS CUI [1])
HLA Match Living related donor | HLA Match Unrelated Donor | Matching HLA-A | Matching HLA-B | Matching HLA-C | Matching HLA-DRB1 | Matching HLA-DQB1
Item
hla matched related or unrelated donor (10/10 matching; hla-a, hla-b, hla-c, hla-drb1, hla-dqb1)
boolean
C4330149 (UMLS CUI [1,1])
C3494891 (UMLS CUI [1,2])
C4330149 (UMLS CUI [2,1])
C3179133 (UMLS CUI [2,2])
C1708943 (UMLS CUI [3,1])
C0019728 (UMLS CUI [3,2])
C1708943 (UMLS CUI [4,1])
C0019737 (UMLS CUI [4,2])
C1708943 (UMLS CUI [5,1])
C0019751 (UMLS CUI [5,2])
C1708943 (UMLS CUI [6,1])
C0122040 (UMLS CUI [6,2])
C1708943 (UMLS CUI [7,1])
C0122020 (UMLS CUI [7,2])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Stable Disease | Progressive Disease
Item
stable or progressive disease according to cheson's criteria1 (annexe 1)
boolean
C0677946 (UMLS CUI [1])
C1335499 (UMLS CUI [2])
Rituximab Absent | Status pre- Relapse
Item
absence of treatment with rituximab before the last relapse
boolean
C0393022 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332152 (UMLS CUI [2,1])
C0035020 (UMLS CUI [2,2])
Heart failure | Cardiac ejection fraction Echocardiography
Item
cardiac insufficiency (ejection fraction < 50% by echocardiography)
boolean
C0018801 (UMLS CUI [1])
C0232174 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Lung disease | Carbon Monoxide Diffusing Capability Test
Item
pulmonary disease characterized by dlco < 60%
boolean
C0024115 (UMLS CUI [1])
C1516251 (UMLS CUI [2])
Renal Insufficiency | Creatinine clearance measurement
Item
renal insufficiency (clearance of creatinin < 60 ml/min)
boolean
C1565489 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Liver diseases | Aspartate Aminotransferase Increased | Alanine Aminotransferase Increased | Elevated total bilirubin | Exception Gilbert Disease | Exception Hepatic lymphoma
Item
hepatic disease characterized by asat and/or alat and/or total bilirubin > 2 times the upper normal value except in case of gilbert's disease or hepatic lymphoma
boolean
C0023895 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0741494 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0017551 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C1112746 (UMLS CUI [6,2])
HIV Seropositivity
Item
hiv positive test
boolean
C0019699 (UMLS CUI [1])
Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled
Item
bacterial, viral or fungal uncontrolled infections
boolean
C0004623 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0042769 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0026946 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
pregnant or breast feeding woman
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
cancer in the last 5 years except in case of cutaneous baso-cellular cancer or epithelioma "in situ" of the uterine cervix
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
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