Eligibility B-Cell Lymphoma Originating in the CNS NCT01235793

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StudyEvent: Eligibility
1. Eligibility B-Cell Lymphoma Originating in the CNS NCT01235793

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

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])

Exclusion Criteria

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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Eligibility B-Cell Lymphoma Originating in the CNS NCT01235793