ID

21144

Description

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

Link

https://clinicaltrials.gov/show/NCT00440388

Keywords

Versions (1)
  1. 4/11/17 4/11/17 -
Uploaded on

April 11, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Follicular Lymphoma NCT00440388

English

Eligibility Follicular Lymphoma NCT00440388

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
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;
Description

Follicular b-cell non-hodgkin's lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C1868944
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;
Description

Follicular Lymphoma International Prognostic Index

Data type

boolean

Alias
UMLS CUI [1]
C4040298
ecog performance status 0-1;
Description

ECOG Performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
measurable disease;
Description

Measurable disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
adequate hematological function as indicated by:
Description

Hematological function

Data type

boolean

Alias
UMLS CUI [1]
C0018941
absolute neutrophil count (anc) >1,000/µl; +hemoglobin >8 g/dl (it is acceptable to transfuse prbc to achieve this criterion);
Description

Neutrophil count and hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0518015
platelet count >50 x 109/l.
Description

Platelet count

Data type

boolean

Alias
UMLS CUI [1]
C0005821
adequate hepatic and renal function as indicated by:
Description

Hepatic and renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
serum creatinine ≤2.0 mg/dl;
Description

Serum creatinine measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201976
serum albumin ≥2.5 g/dl;
Description

Serum albumin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0523465
total bilirubin ≤1.5 x upper limit of normal (uln);
Description

Total bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0201913
serum ast and alt ≤1.5 x uln.
Description

Serum ast and alt measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
able to swallow and retain oral medication
Description

Oral medication

Data type

boolean

Alias
UMLS CUI [1]
C0175795
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
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);
Description

Lymphoma-related symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C1457887
active symptomatic fungal, bacterial and/or viral infection including, but not limited to active hiv or viral hepatitis (a, b or c);
Description

Active infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
history of hepatitis b infection;
Description

History of hepatitis b infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0262926
any b-cell, t-cell or transformed lymphoma other than histologically confirmed follicular non-hodgkin's lymphoma;
Description

Other lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0205394
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;
Description

CNS Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0280803
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Similar models

Eligibility Follicular Lymphoma NCT00440388

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
Oral medication
Item
able to swallow and retain oral medication
boolean
C0175795 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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])
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