Information:
Fel:
ID
21144
Beskrivning
Safety & Efficacy Study of AT-101 in Combination w/ Rituximab in Previously Untreated Grade I-II Follicular Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00440388
Länk
https://clinicaltrials.gov/show/NCT00440388
Nyckelord
Versioner (1)
- 2017-04-11 2017-04-11 -
Uppladdad den
11 april 2017
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Follicular Lymphoma NCT00440388
Eligibility Follicular Lymphoma NCT00440388
- StudyEvent: Eligibility
Similar models
Eligibility Follicular Lymphoma NCT00440388
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Follicular b-cell non-hodgkin's lymphoma
Item
histologically confirmed, previously untreated grade i-ii follicular b-cell non-hodgkin's lymphoma (stage i, ii, iii and iv). patients may have received radiation therapy to one lymph node region; stage i or ii patients must have relapsed after prior radiation therapy to be eligible;
boolean
C1868944 (UMLS CUI [1])
Follicular Lymphoma International Prognostic Index
Item
patients with any flipi score may participate. patients with flipi scores 3-5 may be enrolled with asymptomatic disease, or without worsening disease or disease related-symptoms; however patients with flipi scores of 0-2 must have evidence of worsening disease;
boolean
C4040298 (UMLS CUI [1])
ECOG Performance status
Item
ecog performance status 0-1;
boolean
C1520224 (UMLS CUI [1])
Measurable disease
Item
measurable disease;
boolean
C1513041 (UMLS CUI [1])
Hematological function
Item
adequate hematological function as indicated by:
boolean
C0018941 (UMLS CUI [1])
Neutrophil count and hemoglobin measurement
Item
absolute neutrophil count (anc) >1,000/µl; +hemoglobin >8 g/dl (it is acceptable to transfuse prbc to achieve this criterion);
boolean
C0200633 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0518015 (UMLS CUI [2])
Platelet count
Item
platelet count >50 x 109/l.
boolean
C0005821 (UMLS CUI [1])
Hepatic and renal function
Item
adequate hepatic and renal function as indicated by:
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232804 (UMLS CUI [2])
Serum creatinine measurement
Item
serum creatinine ≤2.0 mg/dl;
boolean
C0201976 (UMLS CUI [1])
Serum albumin measurement
Item
serum albumin ≥2.5 g/dl;
boolean
C0523465 (UMLS CUI [1])
Total bilirubin
Item
total bilirubin ≤1.5 x upper limit of normal (uln);
boolean
C0201913 (UMLS CUI [1])
Serum ast and alt measurement
Item
serum ast and alt ≤1.5 x uln.
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201899 (UMLS CUI [2])
Oral medication
Item
able to swallow and retain oral medication
boolean
C0175795 (UMLS CUI [1])
Lymphoma-related symptoms
Item
patients who have severe lymphoma-related symptoms requiring a rapid response to therapy (e.g., requirement for cytoreduction due to advanced disease or organ compromise, respiratory compromise because of large effusions or airway obstruction, bowel obstruction, ureteral obstruction, and chylous ascites);
boolean
C0024299 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,2])
Active infection
Item
active symptomatic fungal, bacterial and/or viral infection including, but not limited to active hiv or viral hepatitis (a, b or c);
boolean
C0009450 (UMLS CUI [1])
History of hepatitis b infection
Item
history of hepatitis b infection;
boolean
C0019163 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Other lymphoma
Item
any b-cell, t-cell or transformed lymphoma other than histologically confirmed follicular non-hodgkin's lymphoma;
boolean
C0024299 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
CNS Lymphoma
Item
central nervous system (cns) lymphoma, cns or leptomeningeal involvement by lymphoma (treated or in remission), hiv-related lymphoma, or patients with symptoms suggesting hiv infection;
boolean
C0280803 (UMLS CUI [1])