ID

24766

Descripción

Study Combining Zevalin With High-Dose Chemotherapy Prior to Autologous StemCell Transplant in Patients With Relapsed, Refractory, or Transformed Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00438581

Link

https://clinicaltrials.gov/show/NCT00438581

Palabras clave

Versiones (1)
  1. 16/8/17 16/8/17 -
Subido en

16 de agosto de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Non-Hodgkin's Lymphoma NCT00438581

Inglés

Eligibility Non-Hodgkin's Lymphoma NCT00438581

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age >=18 to <=70 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
2. relapsed or refractory stage iii or iv, grade 1,2, or 3 follicular lymphoma or transformed follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, waldenstrom's macroglobulinemia, or diffuse large b-cell lymphoma as defined by the who and:
Descripción

Recurrent Follicular Lymphoma Ann Arbor lymphoma staging system | Refractory Follicular Lymphoma Ann Arbor lymphoma staging system | Follicular Lymphoma transformation | Mantle cell lymphoma | Marginal zone lymphoma | Waldenstrom Macroglobulinemia | Diffuse Large B-Cell Lymphoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1335701
UMLS CUI [1,2]
C0432516
UMLS CUI [2,1]
C1335723
UMLS CUI [2,2]
C0432516
UMLS CUI [3,1]
C0024301
UMLS CUI [3,2]
C1536010
UMLS CUI [4]
C0334634
UMLS CUI [5]
C0242647
UMLS CUI [6]
C0024419
UMLS CUI [7]
C0079744
expressing the cd 20 antigen
Descripción

CD20 Expressing Cell Measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3540684
ecog performance 0-2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
written informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
3. prior collection of at least 2.5x10^6 cd34-positive peripheral blood stem cells/kg.
Descripción

Collection Peripheral blood stem cells CD34 positive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1516698
UMLS CUI [1,2]
C1518999
UMLS CUI [1,3]
C0882849
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. abnormal renal function (creatinine >2.5x upper limit of normal (uln)
Descripción

Abnormal renal function | Creatinine increased

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0151746
UMLS CUI [2]
C0151578
2. abnormal hepatic function (bilirubin >2xuln, alt/ast >3x uln)
Descripción

Liver Dysfunction | Elevated total bilirubin | Alanine aminotransferase increased | Aspartate aminotransferase increased

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0741494
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0151904
3. cardiac ejection fraction <40%
Descripción

Cardiac ejection fraction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232174
4. severe defects in pulmonary function tests (dlco<70% predicted, fev1, fvc<60% predicted) or receiving continuous oxygen
Descripción

Pulmonary function tests Defect Severe | Carbon Monoxide Diffusing Capability Test | Pulmonary Function Test/FEV1 | Forced vital capacity | Oxygen Receive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C1457869
UMLS CUI [1,3]
C0205082
UMLS CUI [2]
C1516251
UMLS CUI [3]
C0849974
UMLS CUI [4]
C1287681
UMLS CUI [5,1]
C0030054
UMLS CUI [5,2]
C1514756
5. a history of human anti-mouse antibodies (hama) or known type 1 hypersensitivity or anaphylactic proteins to any component of the zevalin therapy.
Descripción

Human anti-mouse antibody | Hypersensitivity type Zevalin Component | Anaphylaxis Zevalin Component

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1291910
UMLS CUI [2,1]
C0441750
UMLS CUI [2,2]
C0919274
UMLS CUI [2,3]
C1705248
UMLS CUI [3,1]
C0002792
UMLS CUI [3,2]
C0919274
UMLS CUI [3,3]
C1705248
6. female patients who are pregnant or breast feeding, and adults of reproductive potential who are not employing an effective method of birth control during study treatment
Descripción

Pregnancy | Breast Feeding | Reproductive potential Contraceptive methods Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C4034483
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332268
7. prior radiotherapy to >25% of the bone marrow or >20 gy to critical organ (lung, liver, kidney, spinal cord).
Descripción

Therapeutic radiology procedure Bone Marrow Percentage | Therapeutic radiology procedure Gy Lung | Therapeutic radiology procedure Gy Liver | Therapeutic radiology procedure Gy Kidney | Therapeutic radiology procedure Gy Spinal Cord

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0556636
UMLS CUI [2,3]
C0024109
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0556636
UMLS CUI [3,3]
C0023884
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0556636
UMLS CUI [4,3]
C0022646
UMLS CUI [5,1]
C1522449
UMLS CUI [5,2]
C0556636
UMLS CUI [5,3]
C0037925
8. cns lymphoma
Descripción

Central nervous system lymphoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0742472
9. ongoing infection
Descripción

Communicable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009450
10. prior treatment with radioimmunotherapy
Descripción

Radioimmunotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085101
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Similar models

Eligibility Non-Hodgkin's Lymphoma NCT00438581

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age >=18 to <=70 years
boolean
C0001779 (UMLS CUI [1])
Recurrent Follicular Lymphoma Ann Arbor lymphoma staging system | Refractory Follicular Lymphoma Ann Arbor lymphoma staging system | Follicular Lymphoma transformation | Mantle cell lymphoma | Marginal zone lymphoma | Waldenstrom Macroglobulinemia | Diffuse Large B-Cell Lymphoma
Item
2. relapsed or refractory stage iii or iv, grade 1,2, or 3 follicular lymphoma or transformed follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, waldenstrom's macroglobulinemia, or diffuse large b-cell lymphoma as defined by the who and:
boolean
C1335701 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
C1335723 (UMLS CUI [2,1])
C0432516 (UMLS CUI [2,2])
C0024301 (UMLS CUI [3,1])
C1536010 (UMLS CUI [3,2])
C0334634 (UMLS CUI [4])
C0242647 (UMLS CUI [5])
C0024419 (UMLS CUI [6])
C0079744 (UMLS CUI [7])
CD20 Expressing Cell Measurement
Item
expressing the cd 20 antigen
boolean
C3540684 (UMLS CUI [1])
ECOG performance status
Item
ecog performance 0-2
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Collection Peripheral blood stem cells CD34 positive
Item
3. prior collection of at least 2.5x10^6 cd34-positive peripheral blood stem cells/kg.
boolean
C1516698 (UMLS CUI [1,1])
C1518999 (UMLS CUI [1,2])
C0882849 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Abnormal renal function | Creatinine increased
Item
1. abnormal renal function (creatinine >2.5x upper limit of normal (uln)
boolean
C0151746 (UMLS CUI [1])
C0151578 (UMLS CUI [2])
Liver Dysfunction | Elevated total bilirubin | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
2. abnormal hepatic function (bilirubin >2xuln, alt/ast >3x uln)
boolean
C0086565 (UMLS CUI [1])
C0741494 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
Cardiac ejection fraction
Item
3. cardiac ejection fraction <40%
boolean
C0232174 (UMLS CUI [1])
Pulmonary function tests Defect Severe | Carbon Monoxide Diffusing Capability Test | Pulmonary Function Test/FEV1 | Forced vital capacity | Oxygen Receive
Item
4. severe defects in pulmonary function tests (dlco<70% predicted, fev1, fvc<60% predicted) or receiving continuous oxygen
boolean
C0024119 (UMLS CUI [1,1])
C1457869 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C1516251 (UMLS CUI [2])
C0849974 (UMLS CUI [3])
C1287681 (UMLS CUI [4])
C0030054 (UMLS CUI [5,1])
C1514756 (UMLS CUI [5,2])
Human anti-mouse antibody | Hypersensitivity type Zevalin Component | Anaphylaxis Zevalin Component
Item
5. a history of human anti-mouse antibodies (hama) or known type 1 hypersensitivity or anaphylactic proteins to any component of the zevalin therapy.
boolean
C1291910 (UMLS CUI [1])
C0441750 (UMLS CUI [2,1])
C0919274 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C0002792 (UMLS CUI [3,1])
C0919274 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
Pregnancy | Breast Feeding | Reproductive potential Contraceptive methods Lacking
Item
6. female patients who are pregnant or breast feeding, and adults of reproductive potential who are not employing an effective method of birth control during study treatment
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C4034483 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
Therapeutic radiology procedure Bone Marrow Percentage | Therapeutic radiology procedure Gy Lung | Therapeutic radiology procedure Gy Liver | Therapeutic radiology procedure Gy Kidney | Therapeutic radiology procedure Gy Spinal Cord
Item
7. prior radiotherapy to >25% of the bone marrow or >20 gy to critical organ (lung, liver, kidney, spinal cord).
boolean
C1522449 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0556636 (UMLS CUI [2,2])
C0024109 (UMLS CUI [2,3])
C1522449 (UMLS CUI [3,1])
C0556636 (UMLS CUI [3,2])
C0023884 (UMLS CUI [3,3])
C1522449 (UMLS CUI [4,1])
C0556636 (UMLS CUI [4,2])
C0022646 (UMLS CUI [4,3])
C1522449 (UMLS CUI [5,1])
C0556636 (UMLS CUI [5,2])
C0037925 (UMLS CUI [5,3])
Central nervous system lymphoma
Item
8. cns lymphoma
boolean
C0742472 (UMLS CUI [1])
Communicable Disease
Item
9. ongoing infection
boolean
C0009450 (UMLS CUI [1])
Radioimmunotherapy
Item
10. prior treatment with radioimmunotherapy
boolean
C0085101 (UMLS CUI [1])
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