ID

18411

Beschreibung

Study of 90Y-hLL2 to Treat Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00054834

Link

https://clinicaltrials.gov/show/NCT00054834

Stichworte

Versionen (1)
  1. 03.11.16 03.11.16 -
Hochgeladen am

3. November 2016

DOI

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Creative Commons BY 4.0
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Eligibility Non-Hodgkins Lymphoma NCT00054834

Englisch

Eligibility Non-Hodgkins Lymphoma NCT00054834

1 Formulare  
Criteria
Beschreibung

Criteria

patients with a documented histologic or cytologic diagnosis of b-cell nhl.
Beschreibung

B-Cell Lymphomas

Datentyp

boolean

Alias
UMLS CUI [1]
C0079731
patients who have failed at least one regimen of chemotherapy and are not eligible for any alternate therapies of higher therapeutic priority.
Beschreibung

Chemotherapy Regimen Quantity failed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0231175
patients with at least one measurable tumor site > 1.5 cm in at least one dimension.
Beschreibung

Tumor site Measurable Quantity | Tumor site Measurable Dimensions Quantity | Tumor size

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0475445
UMLS CUI [1,2]
C1513040
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0475445
UMLS CUI [2,2]
C1513040
UMLS CUI [2,3]
C0439534
UMLS CUI [2,4]
C1265611
UMLS CUI [3]
C0475440
prior/concurrent therapy:
Beschreibung

Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0087111
chemotherapy: patients must have failed standard therapy or are not eligible for any alternate therapies of higher therapeutic priority.
Beschreibung

Chemotherapy | Standard of Care failed

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2,1]
C2936643
UMLS CUI [2,2]
C0231175
biologic therapy: patients who have received human or humanized monoclonal antibodies will be eligible provided pre-study evaluations demonstrate no significant reactivity with hll2 igg (i.e., haha).
Beschreibung

Biological Response Modifier Therapy | Antibodies, Monoclonal, Humanized | Reactivity Significant epratuzumab | Reactivity Significant Human Anti-Human Antibody

Datentyp

boolean

Alias
UMLS CUI [1]
C0005527
UMLS CUI [2]
C2985546
UMLS CUI [3,1]
C0443286
UMLS CUI [3,2]
C0750502
UMLS CUI [3,3]
C1120776
UMLS CUI [4,1]
C0443286
UMLS CUI [4,2]
C0750502
UMLS CUI [4,3]
C3641682
radiotherapy: no prior radiation therapy to >25% of the bone marrow. no prior radiation to maximal tolerable levels for any critical organ (e.g., 2,000 cgy for the lungs and kidneys). patients who have had whole pelvic irradiation are not eligible.
Beschreibung

Therapeutic radiology procedure | prior radiation therapy Bone Marrow | prior radiation therapy Lung | prior radiation therapy Kidney | Therapeutic radiology procedure Whole-Pelvis

Datentyp

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0005953
UMLS CUI [3,1]
C0279134
UMLS CUI [3,2]
C0024109
UMLS CUI [4,1]
C0279134
UMLS CUI [4,2]
C0022646
UMLS CUI [5,1]
C1522449
UMLS CUI [5,2]
C3827467
patient characteristics/inclusion criteria:
Beschreibung

Client Characteristics | Inclusion criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0815172
UMLS CUI [2]
C1512693
age range: male or female at least 18 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
performance status: patients with a karnofsky performance status > 60% (or equivalent, ecog 0-2) and expected survival of at least 12 weeks.
Beschreibung

performance status | Karnofsky Performance Status | ECOG performance status | Continuance of life Expected

Datentyp

boolean

Alias
UMLS CUI [1]
C1518965
UMLS CUI [2]
C0206065
UMLS CUI [3]
C1520224
UMLS CUI [4,1]
C0038952
UMLS CUI [4,2]
C1517001
hematopoietic: hemoglobin > 10 g/dl; anc > 1.5x10^9/l; platelets > 100x10^9/l;
Beschreibung

Function Hematopoietic | Hemoglobin | Absolute neutrophil count | Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031843
UMLS CUI [1,2]
C0229601
UMLS CUI [2]
C0019046
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0032181
hepatic: serum bilirubin < 2.0 mg/dl; ast and alt < 2 x uln w/o liver metastases or <5 x uln w/liver metastases
Beschreibung

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0494165
renal: creatinine < 2.0 mg/dl
Beschreibung

Renal function | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
cardiovascular: patients with lvef >/= 50% by muga or 2d-echo.
Beschreibung

Function Cardiovascular | Left ventricular ejection fraction | Multiple gated acquisition scanning | 2D Echocardiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031843
UMLS CUI [1,2]
C3887460
UMLS CUI [2]
C0428772
UMLS CUI [3]
C0521317
UMLS CUI [4]
C0013524
pulmonary: patients with dfco and fev1 >/= 60% by required pulmonary function tests.
Beschreibung

Pulmonary function | Diffusion Factor Carbon Monoxide | FEV1

Datentyp

boolean

Alias
UMLS CUI [1]
C0231921
UMLS CUI [2,1]
C0012222
UMLS CUI [2,2]
C1521761
UMLS CUI [2,3]
C0007018
UMLS CUI [3]
C0748133
other: patients agreeing to use a medically effective method of contraception while enrolled in the study. a pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the study. patients able to understand and give written informed consent.
Beschreibung

Contraceptive methods | Childbearing Potential Premenopausal state Pregnancy Tests | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0232969
UMLS CUI [2,3]
C0032976
UMLS CUI [3]
C0021430
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Ähnliche Modelle

Eligibility Non-Hodgkins Lymphoma NCT00054834

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
B-Cell Lymphomas
Item
patients with a documented histologic or cytologic diagnosis of b-cell nhl.
boolean
C0079731 (UMLS CUI [1])
Chemotherapy Regimen Quantity failed
Item
patients who have failed at least one regimen of chemotherapy and are not eligible for any alternate therapies of higher therapeutic priority.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Tumor site Measurable Quantity | Tumor site Measurable Dimensions Quantity | Tumor size
Item
patients with at least one measurable tumor site > 1.5 cm in at least one dimension.
boolean
C0475445 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0475445 (UMLS CUI [2,1])
C1513040 (UMLS CUI [2,2])
C0439534 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C0475440 (UMLS CUI [3])
Therapeutic procedure
Item
prior/concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Chemotherapy | Standard of Care failed
Item
chemotherapy: patients must have failed standard therapy or are not eligible for any alternate therapies of higher therapeutic priority.
boolean
C0392920 (UMLS CUI [1])
C2936643 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Biological Response Modifier Therapy | Antibodies, Monoclonal, Humanized | Reactivity Significant epratuzumab | Reactivity Significant Human Anti-Human Antibody
Item
biologic therapy: patients who have received human or humanized monoclonal antibodies will be eligible provided pre-study evaluations demonstrate no significant reactivity with hll2 igg (i.e., haha).
boolean
C0005527 (UMLS CUI [1])
C2985546 (UMLS CUI [2])
C0443286 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
C1120776 (UMLS CUI [3,3])
C0443286 (UMLS CUI [4,1])
C0750502 (UMLS CUI [4,2])
C3641682 (UMLS CUI [4,3])
Therapeutic radiology procedure | prior radiation therapy Bone Marrow | prior radiation therapy Lung | prior radiation therapy Kidney | Therapeutic radiology procedure Whole-Pelvis
Item
radiotherapy: no prior radiation therapy to >25% of the bone marrow. no prior radiation to maximal tolerable levels for any critical organ (e.g., 2,000 cgy for the lungs and kidneys). patients who have had whole pelvic irradiation are not eligible.
boolean
C1522449 (UMLS CUI [1])
C0279134 (UMLS CUI [2,1])
C0005953 (UMLS CUI [2,2])
C0279134 (UMLS CUI [3,1])
C0024109 (UMLS CUI [3,2])
C0279134 (UMLS CUI [4,1])
C0022646 (UMLS CUI [4,2])
C1522449 (UMLS CUI [5,1])
C3827467 (UMLS CUI [5,2])
Client Characteristics | Inclusion criteria
Item
patient characteristics/inclusion criteria:
boolean
C0815172 (UMLS CUI [1])
C1512693 (UMLS CUI [2])
Age
Item
age range: male or female at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
performance status | Karnofsky Performance Status | ECOG performance status | Continuance of life Expected
Item
performance status: patients with a karnofsky performance status > 60% (or equivalent, ecog 0-2) and expected survival of at least 12 weeks.
boolean
C1518965 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
C1520224 (UMLS CUI [3])
C0038952 (UMLS CUI [4,1])
C1517001 (UMLS CUI [4,2])
Function Hematopoietic | Hemoglobin | Absolute neutrophil count | Platelet Count measurement
Item
hematopoietic: hemoglobin > 10 g/dl; anc > 1.5x10^9/l; platelets > 100x10^9/l;
boolean
C0031843 (UMLS CUI [1,1])
C0229601 (UMLS CUI [1,2])
C0019046 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver
Item
hepatic: serum bilirubin < 2.0 mg/dl; ast and alt < 2 x uln w/o liver metastases or <5 x uln w/liver metastases
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0494165 (UMLS CUI [5])
Renal function | Creatinine measurement, serum
Item
renal: creatinine < 2.0 mg/dl
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Function Cardiovascular | Left ventricular ejection fraction | Multiple gated acquisition scanning | 2D Echocardiography
Item
cardiovascular: patients with lvef >/= 50% by muga or 2d-echo.
boolean
C0031843 (UMLS CUI [1,1])
C3887460 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2])
C0521317 (UMLS CUI [3])
C0013524 (UMLS CUI [4])
Pulmonary function | Diffusion Factor Carbon Monoxide | FEV1
Item
pulmonary: patients with dfco and fev1 >/= 60% by required pulmonary function tests.
boolean
C0231921 (UMLS CUI [1])
C0012222 (UMLS CUI [2,1])
C1521761 (UMLS CUI [2,2])
C0007018 (UMLS CUI [2,3])
C0748133 (UMLS CUI [3])
Contraceptive methods | Childbearing Potential Premenopausal state Pregnancy Tests | Informed Consent
Item
other: patients agreeing to use a medically effective method of contraception while enrolled in the study. a pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the study. patients able to understand and give written informed consent.
boolean
C0700589 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0232969 (UMLS CUI [2,2])
C0032976 (UMLS CUI [2,3])
C0021430 (UMLS CUI [3])
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