ID

37687

Descripción

The Addition of Temozolomide to Conditioning for Autologous Transplantation in Relapsed & Refractory Central Nervous System (CNS) Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01235793

Link

https://clinicaltrials.gov/show/NCT01235793

Palabras clave

Versiones (1)
  1. 16/8/19 16/8/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

16 de agosto de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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Eligibility B-Cell Lymphoma Originating in the CNS NCT01235793

Inglés

Eligibility B-Cell Lymphoma Originating in the CNS NCT01235793

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients ≥ 18 years of age and ≤ 75 years of age
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
2. patients must have central nervous system (cns) involvement with a mature b-cell non-hodgkin's lymphoma, (who criteria)
Descripción

Central Nervous System Involvement with Mature B-Cell Non-Hodgkin Lymphoma | WHO tumor classification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3714787
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C1334634
UMLS CUI [2]
C1301142
3. patients must meet one of the below criteria:
Descripción

Criteria Quantity Fulfill

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1550543
patients who have achieved a complete response (cr) or partial response (pr) after initial therapy for central nervous system (cns) b-cell lymphoma, or
Descripción

In complete remission | Partial response | Status post First line treatment Central nervous system lymphoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0677874
UMLS CUI [2]
C1521726
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1708063
UMLS CUI [3,3]
C0280803
patients with relapsed or progressed disease following therapy for cns b-cell lymphoma who has achieved a subsequent cr or pr following salvage chemotherapy, or
Descripción

Recurrent disease | Disease Progression | Status post Therapy Central nervous system lymphoma | In complete remission Following Salvage Chemotherapy | Partial response Following Salvage Chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C0242656
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0280803
UMLS CUI [4,1]
C0677874
UMLS CUI [4,2]
C0332282
UMLS CUI [4,3]
C0085405
UMLS CUI [4,4]
C0392920
UMLS CUI [5,1]
C1521726
UMLS CUI [5,2]
C0332282
UMLS CUI [5,3]
C0085405
UMLS CUI [5,4]
C0392920
patients who are initially refractory to therapy for cns b-cell lymphoma but who have achieved a cr or pr following a salvage chemotherapy regimen, or
Descripción

Unresponsive to Therapy Central nervous system lymphoma | In complete remission Following Salvage Chemotherapy | Partial response Following Salvage Chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205269
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0280803
UMLS CUI [2,1]
C0677874
UMLS CUI [2,2]
C0332282
UMLS CUI [2,3]
C0085405
UMLS CUI [2,4]
C0392920
UMLS CUI [3,1]
C1521726
UMLS CUI [3,2]
C0332282
UMLS CUI [3,3]
C0085405
UMLS CUI [3,4]
C0392920
patients who have developed cns relapse from systemic b-cell non-hodgkin's lymphoma, and have evidence of chemotherapy sensitive lymphoma.
Descripción

Central Nervous System Relapse | B-Cell Lymphoma Systemic | Lymphoma Sensitive to Chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3714787
UMLS CUI [1,2]
C0035020
UMLS CUI [2,1]
C0079731
UMLS CUI [2,2]
C0205373
UMLS CUI [3,1]
C0024299
UMLS CUI [3,2]
C0332324
UMLS CUI [3,3]
C0392920
4. patients fit for autologous stem cell transplantation
Descripción

Patients Fit Autologous hematopoietic stem cell transplant

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0424576
UMLS CUI [1,3]
C2193200
5. patients able to understand and willing to sign a written informed consent document
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with primary cns b-cell lymphoma in remission status post primary, initial therapy
Descripción

Primary central nervous system lymphoma | In complete remission Post Primary therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0280803
UMLS CUI [2,1]
C0677874
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C1708063
2. patients initially enrolled at relapse but who were not responsive to induction therapy will not be continued on the study
Descripción

Enrollment During Relapse | Unresponsive to Induction Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0035020
UMLS CUI [2,1]
C0205269
UMLS CUI [2,2]
C0600558
3. patients whose life expectancy is severely limited by diseases other than malignancy
Descripción

Life Expectancy Severely limited | Etiology Disease Except Malignant Neoplasms

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C4489696
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0332300
UMLS CUI [2,4]
C0006826
4. karnofsky performance score <60
Descripción

Karnofsky Performance Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0206065
5. patients who are pregnant or breastfeeding
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
6. patients who are hiv seropositive
Descripción

HIV Seropositivity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019699
7. patients who have an uncontrolled infection (presumed or documented) with progression after appropriate therapy for greater than one month
Descripción

Communicable Disease Uncontrolled | Disease Progression Post Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0087111
8. patients with symptomatic coronary artery disease, uncontrolled congestive heart failure. left ventricular ejection fraction is not required to be measured, however if it is measured, patient is excluded if ejection fraction is <30%
Descripción

Coronary Artery Disease Symptomatic | Congestive heart failure Uncontrolled | Left ventricular ejection fraction

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0428772
9. patients requiring supplementary continuous oxygen.
Descripción

Patient need for Oxygen supplementation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0919655
10. patients with clinical or laboratory evidence of liver disease will be evaluated for the cause of liver disease, its clinical severity in terms of liver function and histology, and for the degree of portal hypertension. patients with any of the following liver function abnormalities will be excluded
Descripción

Liver disease Evaluation Etiology | Liver Function Tests | Portal Hypertension Degree | Liver function tests abnormal finding

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C1261322
UMLS CUI [1,3]
C0015127
UMLS CUI [2]
C0023901
UMLS CUI [3,1]
C0020541
UMLS CUI [3,2]
C0441889
UMLS CUI [4]
C0151766
1. fulminant liver failure
Descripción

Liver Failure, Acute

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0162557
2. cirrhosis with evidence of portal hypertension or bridging fibrosis
Descripción

Liver Cirrhosis | Hypertension, Portal | Bridging fibrosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C0020541
UMLS CUI [3]
C0334160
3. alcoholic hepatitis
Descripción

Hepatitis, Alcoholic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019187
4. esophageal varices
Descripción

Esophageal Varices

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0014867
5. a history of bleeding esophageal varices
Descripción

Bleeding esophageal varices

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0155789
6. hepatic encephalopathy
Descripción

Hepatic Encephalopathy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019151
7. uncorrectable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time
Descripción

Liver Dysfunction | Prolonged prothrombin time

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C2673577
8. ascites related to portal hypertension
Descripción

Ascites Relationship Portal Hypertension

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0020541
9. chronic viral hepatitis with total serum bilirubin >3 mg/dl ____mg/dl
Descripción

Chronic viral hepatitis | Serum total bilirubin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0276623
UMLS CUI [2]
C1278039
10. symptomatic biliary disease
Descripción

Biliary Tract Disease Symptomatic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005424
UMLS CUI [1,2]
C0231220
11. patients with non-b-cell lymphomas or brain tumors that are not lymphomas are excluded from the study. non-b-cell lymphomas include: any t-cell lymphoma, natural killer (nk)-cell lymphomas, and hodgkin lymphomas
Descripción

Lymphoma Except B-Cell Lymphomas | Brain Neoplasms | T-Cell Lymphoma | NK-cell lymphoma | Hodgkin Disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C0079731
UMLS CUI [2]
C0006118
UMLS CUI [3]
C0079772
UMLS CUI [4]
C3647364
UMLS CUI [5]
C0019829
12. patients for whom an insufficient number of stem cells (<2 x 106/kg) have been collected
Descripción

Stem Cell collection Insufficient

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3827940
UMLS CUI [1,2]
C0231180
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Similar models

Eligibility B-Cell Lymphoma Originating in the CNS NCT01235793

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patients ≥ 18 years of age and ≤ 75 years of age
boolean
C0001779 (UMLS CUI [1])
Central Nervous System Involvement with Mature B-Cell Non-Hodgkin Lymphoma | WHO tumor classification
Item
2. patients must have central nervous system (cns) involvement with a mature b-cell non-hodgkin's lymphoma, (who criteria)
boolean
C3714787 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C1334634 (UMLS CUI [1,3])
C1301142 (UMLS CUI [2])
Criteria Quantity Fulfill
Item
3. patients must meet one of the below criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
In complete remission | Partial response | Status post First line treatment Central nervous system lymphoma
Item
patients who have achieved a complete response (cr) or partial response (pr) after initial therapy for central nervous system (cns) b-cell lymphoma, or
boolean
C0677874 (UMLS CUI [1])
C1521726 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C1708063 (UMLS CUI [3,2])
C0280803 (UMLS CUI [3,3])
Recurrent disease | Disease Progression | Status post Therapy Central nervous system lymphoma | In complete remission Following Salvage Chemotherapy | Partial response Following Salvage Chemotherapy
Item
patients with relapsed or progressed disease following therapy for cns b-cell lymphoma who has achieved a subsequent cr or pr following salvage chemotherapy, or
boolean
C0277556 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0280803 (UMLS CUI [3,3])
C0677874 (UMLS CUI [4,1])
C0332282 (UMLS CUI [4,2])
C0085405 (UMLS CUI [4,3])
C0392920 (UMLS CUI [4,4])
C1521726 (UMLS CUI [5,1])
C0332282 (UMLS CUI [5,2])
C0085405 (UMLS CUI [5,3])
C0392920 (UMLS CUI [5,4])
Unresponsive to Therapy Central nervous system lymphoma | In complete remission Following Salvage Chemotherapy | Partial response Following Salvage Chemotherapy
Item
patients who are initially refractory to therapy for cns b-cell lymphoma but who have achieved a cr or pr following a salvage chemotherapy regimen, or
boolean
C0205269 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0280803 (UMLS CUI [1,3])
C0677874 (UMLS CUI [2,1])
C0332282 (UMLS CUI [2,2])
C0085405 (UMLS CUI [2,3])
C0392920 (UMLS CUI [2,4])
C1521726 (UMLS CUI [3,1])
C0332282 (UMLS CUI [3,2])
C0085405 (UMLS CUI [3,3])
C0392920 (UMLS CUI [3,4])
Central Nervous System Relapse | B-Cell Lymphoma Systemic | Lymphoma Sensitive to Chemotherapy
Item
patients who have developed cns relapse from systemic b-cell non-hodgkin's lymphoma, and have evidence of chemotherapy sensitive lymphoma.
boolean
C3714787 (UMLS CUI [1,1])
C0035020 (UMLS CUI [1,2])
C0079731 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0024299 (UMLS CUI [3,1])
C0332324 (UMLS CUI [3,2])
C0392920 (UMLS CUI [3,3])
Patients Fit Autologous hematopoietic stem cell transplant
Item
4. patients fit for autologous stem cell transplantation
boolean
C0030705 (UMLS CUI [1,1])
C0424576 (UMLS CUI [1,2])
C2193200 (UMLS CUI [1,3])
Informed Consent
Item
5. patients able to understand and willing to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Primary central nervous system lymphoma | In complete remission Post Primary therapy
Item
1. patients with primary cns b-cell lymphoma in remission status post primary, initial therapy
boolean
C0280803 (UMLS CUI [1])
C0677874 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C1708063 (UMLS CUI [2,3])
Enrollment During Relapse | Unresponsive to Induction Therapy
Item
2. patients initially enrolled at relapse but who were not responsive to induction therapy will not be continued on the study
boolean
C1516879 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0035020 (UMLS CUI [1,3])
C0205269 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
Life Expectancy Severely limited | Etiology Disease Except Malignant Neoplasms
Item
3. patients whose life expectancy is severely limited by diseases other than malignancy
boolean
C0023671 (UMLS CUI [1,1])
C4489696 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0332300 (UMLS CUI [2,3])
C0006826 (UMLS CUI [2,4])
Karnofsky Performance Status
Item
4. karnofsky performance score <60
boolean
C0206065 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
5. patients who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Seropositivity
Item
6. patients who are hiv seropositive
boolean
C0019699 (UMLS CUI [1])
Communicable Disease Uncontrolled | Disease Progression Post Therapy
Item
7. patients who have an uncontrolled infection (presumed or documented) with progression after appropriate therapy for greater than one month
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
Coronary Artery Disease Symptomatic | Congestive heart failure Uncontrolled | Left ventricular ejection fraction
Item
8. patients with symptomatic coronary artery disease, uncontrolled congestive heart failure. left ventricular ejection fraction is not required to be measured, however if it is measured, patient is excluded if ejection fraction is <30%
boolean
C1956346 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0428772 (UMLS CUI [3])
Patient need for Oxygen supplementation
Item
9. patients requiring supplementary continuous oxygen.
boolean
C0686904 (UMLS CUI [1,1])
C0919655 (UMLS CUI [1,2])
Liver disease Evaluation Etiology | Liver Function Tests | Portal Hypertension Degree | Liver function tests abnormal finding
Item
10. patients with clinical or laboratory evidence of liver disease will be evaluated for the cause of liver disease, its clinical severity in terms of liver function and histology, and for the degree of portal hypertension. patients with any of the following liver function abnormalities will be excluded
boolean
C0023895 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0023901 (UMLS CUI [2])
C0020541 (UMLS CUI [3,1])
C0441889 (UMLS CUI [3,2])
C0151766 (UMLS CUI [4])
Liver Failure, Acute
Item
1. fulminant liver failure
boolean
C0162557 (UMLS CUI [1])
Liver Cirrhosis | Hypertension, Portal | Bridging fibrosis
Item
2. cirrhosis with evidence of portal hypertension or bridging fibrosis
boolean
C0023890 (UMLS CUI [1])
C0020541 (UMLS CUI [2])
C0334160 (UMLS CUI [3])
Hepatitis, Alcoholic
Item
3. alcoholic hepatitis
boolean
C0019187 (UMLS CUI [1])
Esophageal Varices
Item
4. esophageal varices
boolean
C0014867 (UMLS CUI [1])
Bleeding esophageal varices
Item
5. a history of bleeding esophageal varices
boolean
C0155789 (UMLS CUI [1])
Hepatic Encephalopathy
Item
6. hepatic encephalopathy
boolean
C0019151 (UMLS CUI [1])
Liver Dysfunction | Prolonged prothrombin time
Item
7. uncorrectable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time
boolean
C0086565 (UMLS CUI [1])
C2673577 (UMLS CUI [2])
Ascites Relationship Portal Hypertension
Item
8. ascites related to portal hypertension
boolean
C0003962 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0020541 (UMLS CUI [1,3])
Chronic viral hepatitis | Serum total bilirubin measurement
Item
9. chronic viral hepatitis with total serum bilirubin >3 mg/dl ____mg/dl
boolean
C0276623 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
Biliary Tract Disease Symptomatic
Item
10. symptomatic biliary disease
boolean
C0005424 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Lymphoma Except B-Cell Lymphomas | Brain Neoplasms | T-Cell Lymphoma | NK-cell lymphoma | Hodgkin Disease
Item
11. patients with non-b-cell lymphomas or brain tumors that are not lymphomas are excluded from the study. non-b-cell lymphomas include: any t-cell lymphoma, natural killer (nk)-cell lymphomas, and hodgkin lymphomas
boolean
C0024299 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0079731 (UMLS CUI [1,3])
C0006118 (UMLS CUI [2])
C0079772 (UMLS CUI [3])
C3647364 (UMLS CUI [4])
C0019829 (UMLS CUI [5])
Stem Cell collection Insufficient
Item
12. patients for whom an insufficient number of stem cells (<2 x 106/kg) have been collected
boolean
C3827940 (UMLS CUI [1,1])
C0231180 (UMLS CUI [1,2])
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