ID

43827

Beschreibung

Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T-Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00290433

Link

https://clinicaltrials.gov/show/NCT00290433

Stichworte

Versionen (2)
  1. 12.10.16 12.10.16 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00290433

Englisch

Eligibility Lymphoma NCT00290433

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00290433
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. confirmed diagnosis of previously untreated t-cell non hodgkin's lymphomas and nk lymphomas, with the exception of cluster of differentiation antigen 30 (cd30+) alk1+
Beschreibung

T-Cell Lymphoma untreated | NK-cell lymphoma | Lymphoma CD30 positive ALK positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079772
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C3647364
UMLS CUI [3,1]
C0024299
UMLS CUI [3,2]
C3888910
UMLS CUI [3,3]
C0252409
UMLS CUI [3,4]
C1514241
t-anaplastic large cell lymphoma (alcl). patients with skin involvement alone are also excluded. for patients with skin involvement as part of systemic disease, prior topical treatment only is allowed.
Beschreibung

Adult Anaplastic Large Cell Lymphoma T-cell | Skin Involvement | Systemic disease Skin Involvement | Therapeutic procedure Topical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1332182
UMLS CUI [1,2]
C0039194
UMLS CUI [2,1]
C1123023
UMLS CUI [2,2]
C1314939
UMLS CUI [3,1]
C0442893
UMLS CUI [3,2]
C1123023
UMLS CUI [3,3]
C1314939
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C1522168
2. patients with a performance status of 3 or less (zubrod scale - see appendix d).
Beschreibung

Zubrod Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C3714786
3. serum bilirubin </= 1.5 mg/dl and serum creatinine </= 2.0 mg/dl unless due to lymphoma; absolute neutrophil count (anc) >/= 1000 mm^3 and platelets >/= 100,000 mm^3 unless due to lymphoma.
Beschreibung

Serum total bilirubin measurement | Creatinine measurement, serum | Absolute neutrophil count | Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0032181
4. cardiac ejection fraction 50% or greater by multigated radionuclide angiography (muga) or echocardiogram.
Beschreibung

Cardiac ejection fraction | MUGA | Echocardiography

Datentyp

boolean

Alias
UMLS CUI [1]
C0232174
UMLS CUI [2]
C0521317
UMLS CUI [3]
C0013516
5. ages 18 and older.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
6. patients must be willing to receive transfusions of blood products.
Beschreibung

Transfusion, blood or blood components

Datentyp

boolean

Alias
UMLS CUI [1]
C0371802
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with cd30+ alk1+ t-anaplastic large cell lymphoma (alcl) or patients with skin involvement alone.
Beschreibung

T-Anaplastic Large Cell Lymphoma CD30 positive ALK Positive | Skin Involvement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1332182
UMLS CUI [1,2]
C0039194
UMLS CUI [1,3]
C3888910
UMLS CUI [1,4]
C0252409
UMLS CUI [1,5]
C1514241
UMLS CUI [2,1]
C1123023
UMLS CUI [2,2]
C1314939
2. pregnancy
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
3. hiv positive serology
Beschreibung

HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
4. central nervous system (cns) involvement
Beschreibung

Central Nervous System Involvement

Datentyp

boolean

Alias
UMLS CUI [1]
C4050309
5. co-morbid medical, such as child's class c liver cirrhosis, end-stage renal disease, and symptomatic congestive heart failure, or psychiatric illnesses that preclude treatment with intense dose chemotherapy as determined by the primary investigator
Beschreibung

Comorbidity Excludes Chemotherapy High dose | Liver Cirrhosis | Child-Pugh Classification | Kidney Failure, Chronic | Symptomatic congestive heart failure | Mental disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C3665472
UMLS CUI [1,4]
C0444956
UMLS CUI [2]
C0023890
UMLS CUI [3]
C4050412
UMLS CUI [4]
C0022661
UMLS CUI [5]
C0742758
UMLS CUI [6]
C0004936
6. concurrent or previous malignancy whose prognosis is poor (<90% probability of survival at 5 years)
Beschreibung

Malignant Neoplasm Prognosis bad | Continuance of life Percentage Probability

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0278252
UMLS CUI [2,1]
C0038952
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0033204
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Ähnliche Modelle

Eligibility Lymphoma NCT00290433

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00290433
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
T-Cell Lymphoma untreated | NK-cell lymphoma | Lymphoma CD30 positive ALK positive
Item
1. confirmed diagnosis of previously untreated t-cell non hodgkin's lymphomas and nk lymphomas, with the exception of cluster of differentiation antigen 30 (cd30+) alk1+
boolean
C0079772 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C3647364 (UMLS CUI [2])
C0024299 (UMLS CUI [3,1])
C3888910 (UMLS CUI [3,2])
C0252409 (UMLS CUI [3,3])
C1514241 (UMLS CUI [3,4])
Adult Anaplastic Large Cell Lymphoma T-cell | Skin Involvement | Systemic disease Skin Involvement | Therapeutic procedure Topical
Item
t-anaplastic large cell lymphoma (alcl). patients with skin involvement alone are also excluded. for patients with skin involvement as part of systemic disease, prior topical treatment only is allowed.
boolean
C1332182 (UMLS CUI [1,1])
C0039194 (UMLS CUI [1,2])
C1123023 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0442893 (UMLS CUI [3,1])
C1123023 (UMLS CUI [3,2])
C1314939 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C1522168 (UMLS CUI [4,2])
Zubrod Performance Status
Item
2. patients with a performance status of 3 or less (zubrod scale - see appendix d).
boolean
C3714786 (UMLS CUI [1])
Serum total bilirubin measurement | Creatinine measurement, serum | Absolute neutrophil count | Platelet Count measurement
Item
3. serum bilirubin </= 1.5 mg/dl and serum creatinine </= 2.0 mg/dl unless due to lymphoma; absolute neutrophil count (anc) >/= 1000 mm^3 and platelets >/= 100,000 mm^3 unless due to lymphoma.
boolean
C1278039 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
Cardiac ejection fraction | MUGA | Echocardiography
Item
4. cardiac ejection fraction 50% or greater by multigated radionuclide angiography (muga) or echocardiogram.
boolean
C0232174 (UMLS CUI [1])
C0521317 (UMLS CUI [2])
C0013516 (UMLS CUI [3])
Age
Item
5. ages 18 and older.
boolean
C0001779 (UMLS CUI [1])
Transfusion, blood or blood components
Item
6. patients must be willing to receive transfusions of blood products.
boolean
C0371802 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
T-Anaplastic Large Cell Lymphoma CD30 positive ALK Positive | Skin Involvement
Item
1. patients with cd30+ alk1+ t-anaplastic large cell lymphoma (alcl) or patients with skin involvement alone.
boolean
C1332182 (UMLS CUI [1,1])
C0039194 (UMLS CUI [1,2])
C3888910 (UMLS CUI [1,3])
C0252409 (UMLS CUI [1,4])
C1514241 (UMLS CUI [1,5])
C1123023 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
Pregnancy
Item
2. pregnancy
boolean
C0032961 (UMLS CUI [1])
HIV Seropositivity
Item
3. hiv positive serology
boolean
C0019699 (UMLS CUI [1])
Central Nervous System Involvement
Item
4. central nervous system (cns) involvement
boolean
C4050309 (UMLS CUI [1])
Comorbidity Excludes Chemotherapy High dose | Liver Cirrhosis | Child-Pugh Classification | Kidney Failure, Chronic | Symptomatic congestive heart failure | Mental disorders
Item
5. co-morbid medical, such as child's class c liver cirrhosis, end-stage renal disease, and symptomatic congestive heart failure, or psychiatric illnesses that preclude treatment with intense dose chemotherapy as determined by the primary investigator
boolean
C0009488 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C3665472 (UMLS CUI [1,3])
C0444956 (UMLS CUI [1,4])
C0023890 (UMLS CUI [2])
C4050412 (UMLS CUI [3])
C0022661 (UMLS CUI [4])
C0742758 (UMLS CUI [5])
C0004936 (UMLS CUI [6])
Malignant Neoplasm Prognosis bad | Continuance of life Percentage Probability
Item
6. concurrent or previous malignancy whose prognosis is poor (<90% probability of survival at 5 years)
boolean
C0006826 (UMLS CUI [1,1])
C0278252 (UMLS CUI [1,2])
C0038952 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0033204 (UMLS CUI [2,3])
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