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ID

37687

Beschrijving

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

Trefwoorden

Versies (1)
  1. 16-08-19 16-08-19 -
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See clinicaltrials.gov

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16 augustus 2019

DOI

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

    Engels

    Eligibility B-Cell Lymphoma Originating in the CNS NCT01235793

    1 Formulieren  
    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

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

    Age

    Datatype

    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)
    Beschrijving

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

    Datatype

    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:
    Beschrijving

    Criteria Quantity Fulfill

    Datatype

    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
    Beschrijving

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

    Datatype

    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
    Beschrijving

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

    Datatype

    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
    Beschrijving

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

    Datatype

    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.
    Beschrijving

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

    Datatype

    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
    Beschrijving

    Patients Fit Autologous hematopoietic stem cell transplant

    Datatype

    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
    Beschrijving

    Informed Consent

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

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

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

    Datatype

    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
    Beschrijving

    Enrollment During Relapse | Unresponsive to Induction Therapy

    Datatype

    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
    Beschrijving

    Life Expectancy Severely limited | Etiology Disease Except Malignant Neoplasms

    Datatype

    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
    Beschrijving

    Karnofsky Performance Status

    Datatype

    boolean

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

    Pregnancy | Breast Feeding

    Datatype

    boolean

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

    HIV Seropositivity

    Datatype

    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
    Beschrijving

    Communicable Disease Uncontrolled | Disease Progression Post Therapy

    Datatype

    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%
    Beschrijving

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

    Datatype

    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.
    Beschrijving

    Patient need for Oxygen supplementation

    Datatype

    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
    Beschrijving

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

    Datatype

    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
    Beschrijving

    Liver Failure, Acute

    Datatype

    boolean

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

    Liver Cirrhosis | Hypertension, Portal | Bridging fibrosis

    Datatype

    boolean

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

    Hepatitis, Alcoholic

    Datatype

    boolean

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

    Esophageal Varices

    Datatype

    boolean

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

    Bleeding esophageal varices

    Datatype

    boolean

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

    Hepatic Encephalopathy

    Datatype

    boolean

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

    Liver Dysfunction | Prolonged prothrombin time

    Datatype

    boolean

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

    Ascites Relationship Portal Hypertension

    Datatype

    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
    Beschrijving

    Chronic viral hepatitis | Serum total bilirubin measurement

    Datatype

    boolean

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

    Biliary Tract Disease Symptomatic

    Datatype

    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
    Beschrijving

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

    Datatype

    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
    Beschrijving

    Stem Cell collection Insufficient

    Datatype

    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 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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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