ID

16725

Description

Rituximab, Methotrexate, Procarbazine and Vincristine Followed by High-dose Chemotherapy With Autologous Stem-cell Rescue in Newly-diagnosed Primary CNS Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00596154

Link

https://clinicaltrials.gov/show/NCT00596154

Keywords

Versions (1)
  1. 8/2/16 8/2/16 -
Uploaded on

August 2, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility CNS Lymphoma NCT00596154

English

Eligibility CNS Lymphoma NCT00596154

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
all patients must have non-hodgkin's lymphoma involving the brain, as demonstrated by ct or mri and histologic confirmation by one of the following: a positive csf cytology for lymphoma or a monoclonal lymphocyte population as defined by cell surface markers.
Description

Non-Hodgkin Lymphoma Involvement with Brain | X-Ray Computed Tomography | Magnetic Resonance Imaging | Cerebrospinal Fluid Cytology Positive Lymphoma | Lymphocyte | Surface Antigens

Data type

boolean

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0006104
UMLS CUI [2]
C0040405
UMLS CUI [3]
C0024485
UMLS CUI [4,1]
C0007806
UMLS CUI [4,2]
C1305671
UMLS CUI [4,3]
C1446409
UMLS CUI [4,4]
C0024299
UMLS CUI [5]
C0024264
UMLS CUI [6]
C0003339
a biopsy of the vitreous or uvea demonstrating non-hodgkin's lymphoma. brain biopsy.
Description

Lymphoma, Non-Hodgkin | Biopsy of vitreous | Biopsy Uvea | Biopsy brain

Data type

boolean

Alias
UMLS CUI [1]
C0024305
UMLS CUI [2]
C0395547
UMLS CUI [3,1]
C0005558
UMLS CUI [3,2]
C0042160
UMLS CUI [4]
C0740294
patients must be hiv-1 negative.
Description

HIV-1 Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C2363741
UMLS CUI [1,2]
C0205160
patient must have left ventricular ejection fraction ≥ 50%.
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
patients must have no evidence of systemic lymphoma. this must be demonstrated by a ct scan of the chest, abdomen and pelvis prior to registration.
Description

Lymphoma Systemic Evidence | Chest CT | CT of abdomen | Computerized Tomography (CT Scan) of Pelvis

Data type

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0332120
UMLS CUI [2]
C0202823
UMLS CUI [3]
C0412620
UMLS CUI [4]
C2456699
patients must have adequate bone marrow function (defined as peripheral leucocyte count >3000 cells/mm3 and platelet count > 100,000 cells/mm3), liver function (bilirubin < 2.0 mg%), and adequate renal function (serum creatinine < 1.5 mg/dl or creatinine clearance > 50cc/min/1.73m2).
Description

Bone Marrow function | White Blood Cell Count | Blood Platelets | Liver function | Serum total bilirubin measurement | Renal function | Creatinine measurement, serum | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0005821
UMLS CUI [4]
C0232741
UMLS CUI [5]
C1278039
UMLS CUI [6]
C0232804
UMLS CUI [7]
C0201976
UMLS CUI [8]
C0373595
men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.
Description

Females & males of reproductive potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
patients must be between 18 and 72 years-old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients must sign an informed consent.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior cranial irradiation
Description

Cranial Irradiation

Data type

boolean

Alias
UMLS CUI [1]
C0079172
other active primary malignancy with the exception of basal cell carcinoma of the skin and cervical carcinoma in situ.
Description

Primary malignant neoplasm | Basal cell carcinoma | Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C1306459
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0851140
pre-existing immunodeficiency such as renal transplant recipient.
Description

Immunologic Deficiency Syndrome Pre-existing | Renal graft Recipient

Data type

boolean

Alias
UMLS CUI [1,1]
C0021051
UMLS CUI [1,2]
C2347662
UMLS CUI [2,1]
C0022671
UMLS CUI [2,2]
C1709854
prior treatment with chemotherapy for cns lymphoma.
Description

Prior Chemotherapy Primary central nervous system lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0280803
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Similar models

Eligibility CNS Lymphoma NCT00596154

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Hodgkin Lymphoma Involvement with Brain | X-Ray Computed Tomography | Magnetic Resonance Imaging | Cerebrospinal Fluid Cytology Positive Lymphoma | Lymphocyte | Surface Antigens
Item
all patients must have non-hodgkin's lymphoma involving the brain, as demonstrated by ct or mri and histologic confirmation by one of the following: a positive csf cytology for lymphoma or a monoclonal lymphocyte population as defined by cell surface markers.
boolean
C0024305 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0006104 (UMLS CUI [1,3])
C0040405 (UMLS CUI [2])
C0024485 (UMLS CUI [3])
C0007806 (UMLS CUI [4,1])
C1305671 (UMLS CUI [4,2])
C1446409 (UMLS CUI [4,3])
C0024299 (UMLS CUI [4,4])
C0024264 (UMLS CUI [5])
C0003339 (UMLS CUI [6])
Lymphoma, Non-Hodgkin | Biopsy of vitreous | Biopsy Uvea | Biopsy brain
Item
a biopsy of the vitreous or uvea demonstrating non-hodgkin's lymphoma. brain biopsy.
boolean
C0024305 (UMLS CUI [1])
C0395547 (UMLS CUI [2])
C0005558 (UMLS CUI [3,1])
C0042160 (UMLS CUI [3,2])
C0740294 (UMLS CUI [4])
HIV-1 Negative
Item
patients must be hiv-1 negative.
boolean
C2363741 (UMLS CUI [1,1])
C0205160 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
patient must have left ventricular ejection fraction ≥ 50%.
boolean
C0428772 (UMLS CUI [1])
Lymphoma Systemic Evidence | Chest CT | CT of abdomen | Computerized Tomography (CT Scan) of Pelvis
Item
patients must have no evidence of systemic lymphoma. this must be demonstrated by a ct scan of the chest, abdomen and pelvis prior to registration.
boolean
C0024299 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
C0202823 (UMLS CUI [2])
C0412620 (UMLS CUI [3])
C2456699 (UMLS CUI [4])
Bone Marrow function | White Blood Cell Count | Blood Platelets | Liver function | Serum total bilirubin measurement | Renal function | Creatinine measurement, serum | Creatinine clearance measurement
Item
patients must have adequate bone marrow function (defined as peripheral leucocyte count >3000 cells/mm3 and platelet count > 100,000 cells/mm3), liver function (bilirubin < 2.0 mg%), and adequate renal function (serum creatinine < 1.5 mg/dl or creatinine clearance > 50cc/min/1.73m2).
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0023508 (UMLS CUI [2])
C0005821 (UMLS CUI [3])
C0232741 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0232804 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
C0373595 (UMLS CUI [8])
Females & males of reproductive potential Contraceptive methods
Item
men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Age
Item
patients must be between 18 and 72 years-old.
boolean
C0001779 (UMLS CUI [1])
Informed consent
Item
patients must sign an informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cranial Irradiation
Item
prior cranial irradiation
boolean
C0079172 (UMLS CUI [1])
Primary malignant neoplasm | Basal cell carcinoma | Carcinoma in situ of uterine cervix
Item
other active primary malignancy with the exception of basal cell carcinoma of the skin and cervical carcinoma in situ.
boolean
C1306459 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
Immunologic Deficiency Syndrome Pre-existing | Renal graft Recipient
Item
pre-existing immunodeficiency such as renal transplant recipient.
boolean
C0021051 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0022671 (UMLS CUI [2,1])
C1709854 (UMLS CUI [2,2])
Prior Chemotherapy Primary central nervous system lymphoma
Item
prior treatment with chemotherapy for cns lymphoma.
boolean
C1514457 (UMLS CUI [1,1])
C0280803 (UMLS CUI [1,2])
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