ID

24766

Beschreibung

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

Stichworte

Versionen (1)
  1. 16.08.17 16.08.17 -
Hochgeladen am

16. August 2017

DOI

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Lizenz

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

Englisch

Eligibility Non-Hodgkin's Lymphoma NCT00438581

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age

Datentyp

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:
Beschreibung

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

Datentyp

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
Beschreibung

CD20 Expressing Cell Measurement

Datentyp

boolean

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

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

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

Collection Peripheral blood stem cells CD34 positive

Datentyp

boolean

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

Exclusion Criteria

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

Abnormal renal function | Creatinine increased

Datentyp

boolean

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

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

Datentyp

boolean

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

Cardiac ejection fraction

Datentyp

boolean

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

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

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Pregnancy | Breast Feeding | Reproductive potential Contraceptive methods Lacking

Datentyp

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).
Beschreibung

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

Datentyp

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
Beschreibung

Central nervous system lymphoma

Datentyp

boolean

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

Communicable Disease

Datentyp

boolean

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

Radioimmunotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0085101
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Ähnliche Modelle

Eligibility Non-Hodgkin's Lymphoma NCT00438581

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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