ID

44699

Beschreibung

Rituximab-HCVAD in Patients With B-Cell Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00290498

Link

https://clinicaltrials.gov/show/NCT00290498

Stichworte

Versionen (2)
  1. 25.04.17 25.04.17 -
  2. 27.09.21 27.09.21 -
Hochgeladen am

27. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00290498

Englisch

Eligibility Lymphoma NCT00290498

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00290498
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. confirmed diagnosis of previously untreated large b-cell non hodgkin's, large cell lymphoma and b-cell with high grade features. other aggressive lymphomas such as primary mediastinal large b-cell lymphomas will be also allowed to be included.
Beschreibung

Diffuse Large B-Cell Lymphoma | Reticulosarcoma | High grade B-cell lymphoma | Aggressive Lymphoma | Mediastinal Large B-Cell Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0079744
UMLS CUI [2]
C0024302
UMLS CUI [3]
C0456863
UMLS CUI [4]
C1332225
UMLS CUI [5]
C1292754
2. patients with performance status of 0-2 (zubrod scale).
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; anc >1000/mm^3 and platelets >100,000/mm^3 unless due to lymphoma.
Beschreibung

Serum total bilirubin measurement | Creatinine measurement, serum | Serum creatinine measurement Due to Lymphoma | Absolute neutrophil count | Platelet Count measurement | Platelet Count measurement Due to Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201976
UMLS CUI [3,1]
C0201976
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0024299
UMLS CUI [4]
C0948762
UMLS CUI [5]
C0032181
UMLS CUI [6,1]
C0032181
UMLS CUI [6,2]
C0678226
UMLS CUI [6,3]
C0024299
4. cardiac ejection fraction 50% or greater.
Beschreibung

Cardiac ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0232174
5. ages 16 - 60 years (due to the fact that chop-r is not studied enough in younger patients and is not considered standard of care).
Beschreibung

Age

Datentyp

boolean

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

Blood Transfusion Receive Willing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005841
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C0600109
7. age adjusted international prognostic index score of 2 or more
Beschreibung

International Prognostic Index Age Adjusted

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512894
UMLS CUI [1,2]
C0001779
UMLS CUI [1,3]
C0456081
8. previous steroids are allowed (if used to relieve some symptoms such as svc, etc).
Beschreibung

Steroids | Superior Vena Cava Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0038317
UMLS CUI [2]
C0038833
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnancy (excluded due to the teratogenicity of the involved chemotherapy agents
Beschreibung

Pregnancy | Teratogenicity | Antineoplastic Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0232910
UMLS CUI [3]
C0003392
2. positive hiv serology because of poor tolerance to this intense chemotherapy regimen
Beschreibung

HIV Seropositivity | Tolerance Poor Chemotherapy High dose

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C0034537
UMLS CUI [2,2]
C0542537
UMLS CUI [2,3]
C0392920
UMLS CUI [2,4]
C0444956
3. burkitt's lymphomas, and mantle cell lymphoma, transformed follicular center cell lymphoma, follicular grade iii.
Beschreibung

Burkitt Lymphoma | Mantle cell lymphoma | Follicular center cell lymphoma transformed | Follicular Lymphoma Grade

Datentyp

boolean

Alias
UMLS CUI [1]
C0006413
UMLS CUI [2]
C0334634
UMLS CUI [3,1]
C0474849
UMLS CUI [3,2]
C1510411
UMLS CUI [4,1]
C0024301
UMLS CUI [4,2]
C0441800
4. any clinical or cytological diagnosis of cns involvement
Beschreibung

Central Nervous System Involvement

Datentyp

boolean

Alias
UMLS CUI [1]
C4050309
5. any 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]
C0392920
UMLS CUI [1,4]
C0444956
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C4050412
UMLS CUI [3]
C0022661
UMLS CUI [4]
C0742758
UMLS CUI [5]
C0004936
6. concurrent or previous malignancy whose prognosis is poor (< 90% probability of survival at 5 years)
Beschreibung

Malignant Neoplasm Prognosis bad | Survival Probability Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0278252
UMLS CUI [2,1]
C0038952
UMLS CUI [2,2]
C0033204
UMLS CUI [2,3]
C0439165
7. active hepatitis b or c. chronic carriers for hepatitis b will be excluded.
Beschreibung

Hepatitis B | Hepatitis C | Hepatitis B, Chronic

Datentyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0524909
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Ähnliche Modelle

Eligibility Lymphoma NCT00290498

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00290498
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diffuse Large B-Cell Lymphoma | Reticulosarcoma | High grade B-cell lymphoma | Aggressive Lymphoma | Mediastinal Large B-Cell Lymphoma
Item
1. confirmed diagnosis of previously untreated large b-cell non hodgkin's, large cell lymphoma and b-cell with high grade features. other aggressive lymphomas such as primary mediastinal large b-cell lymphomas will be also allowed to be included.
boolean
C0079744 (UMLS CUI [1])
C0024302 (UMLS CUI [2])
C0456863 (UMLS CUI [3])
C1332225 (UMLS CUI [4])
C1292754 (UMLS CUI [5])
Zubrod Performance Status
Item
2. patients with performance status of 0-2 (zubrod scale).
boolean
C3714786 (UMLS CUI [1])
Serum total bilirubin measurement | Creatinine measurement, serum | Serum creatinine measurement Due to Lymphoma | Absolute neutrophil count | Platelet Count measurement | Platelet Count measurement Due to Lymphoma
Item
3. serum bilirubin <1.5 mg/dl and serum creatinine < 2.0 mg/dl unless due to lymphoma; anc >1000/mm^3 and platelets >100,000/mm^3 unless due to lymphoma.
boolean
C1278039 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0201976 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0024299 (UMLS CUI [3,3])
C0948762 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C0032181 (UMLS CUI [6,1])
C0678226 (UMLS CUI [6,2])
C0024299 (UMLS CUI [6,3])
Cardiac ejection fraction
Item
4. cardiac ejection fraction 50% or greater.
boolean
C0232174 (UMLS CUI [1])
Age
Item
5. ages 16 - 60 years (due to the fact that chop-r is not studied enough in younger patients and is not considered standard of care).
boolean
C0001779 (UMLS CUI [1])
Blood Transfusion Receive Willing
Item
6. patients must be willing to receive transfusions of blood products.
boolean
C0005841 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
International Prognostic Index Age Adjusted
Item
7. age adjusted international prognostic index score of 2 or more
boolean
C1512894 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0456081 (UMLS CUI [1,3])
Steroids | Superior Vena Cava Syndrome
Item
8. previous steroids are allowed (if used to relieve some symptoms such as svc, etc).
boolean
C0038317 (UMLS CUI [1])
C0038833 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Teratogenicity | Antineoplastic Agents
Item
1. pregnancy (excluded due to the teratogenicity of the involved chemotherapy agents
boolean
C0032961 (UMLS CUI [1])
C0232910 (UMLS CUI [2])
C0003392 (UMLS CUI [3])
HIV Seropositivity | Tolerance Poor Chemotherapy High dose
Item
2. positive hiv serology because of poor tolerance to this intense chemotherapy regimen
boolean
C0019699 (UMLS CUI [1])
C0034537 (UMLS CUI [2,1])
C0542537 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
C0444956 (UMLS CUI [2,4])
Burkitt Lymphoma | Mantle cell lymphoma | Follicular center cell lymphoma transformed | Follicular Lymphoma Grade
Item
3. burkitt's lymphomas, and mantle cell lymphoma, transformed follicular center cell lymphoma, follicular grade iii.
boolean
C0006413 (UMLS CUI [1])
C0334634 (UMLS CUI [2])
C0474849 (UMLS CUI [3,1])
C1510411 (UMLS CUI [3,2])
C0024301 (UMLS CUI [4,1])
C0441800 (UMLS CUI [4,2])
Central Nervous System Involvement
Item
4. any clinical or cytological diagnosis of 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. any 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])
C0392920 (UMLS CUI [1,3])
C0444956 (UMLS CUI [1,4])
C0023890 (UMLS CUI [2,1])
C4050412 (UMLS CUI [2,2])
C0022661 (UMLS CUI [3])
C0742758 (UMLS CUI [4])
C0004936 (UMLS CUI [5])
Malignant Neoplasm Prognosis bad | Survival Probability Percentage
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])
C0033204 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
Hepatitis B | Hepatitis C | Hepatitis B, Chronic
Item
7. active hepatitis b or c. chronic carriers for hepatitis b will be excluded.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0524909 (UMLS CUI [3])
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