ID

14468

Description

Rituximab + GM-CSF in Patients With Follicular B-Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01939730

Link

https://clinicaltrials.gov/show/NCT01939730

Keywords

Versions (1)
  1. 4/17/16 4/17/16 -
Uploaded on

April 17, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Lymphoma NCT01939730

English

Eligibility Lymphoma NCT01939730

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT01939730
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically confirmed follicular b-cell lymphoma. this can include relapsed patients, who have had no prior rituximab therapy, or previously untreated patients. previously untreated patients should be made aware of higher priority protocols such as combination chemo-immunotherapy protocols, but if they decline that, they can be entered on this protocol.
Description

Follicular b-cell lymphoma: Disease status

Data type

boolean

Alias
UMLS CUI [1]
C0024301
UMLS CUI [2]
C0277556
UMLS CUI [3,1]
C0393022
UMLS CUI [3,2]
C0332155
UMLS CUI [4]
C0332155
2. males or females, 18 years or older; expected survival of =/> 4 months; performance status of 0, 1 or 2.
Description

Patient status

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0023671
UMLS CUI [4]
C1518965
3. demonstrable monoclonal cluster of differentiation antigen 20 (cd20)-positive b-cell population.
Description

Monoclonal cluster of differentiation cd20-positive b-cells

Data type

boolean

Alias
UMLS CUI [1,1]
C0746619
UMLS CUI [1,2]
C0054946
UMLS CUI [1,3]
C0004561
4. acceptable hematologic status including:
Description

Hematologic function

Data type

boolean

Alias
UMLS CUI [1]
C0221130
i. hemoglobin (hgb) =/> 8.0 gm/dl
Description

Hemoglobin

Data type

boolean

Alias
UMLS CUI [1]
C0518015
ii. white blood count (wbc) =/> 3.0 x 10^3/mm^3(x 10^9/l)
Description

White blood count

Data type

boolean

Alias
UMLS CUI [1]
C0023508
iii. absolute granulocyte count =/> 1.5 x 10^3/mm^3
Description

Absolute granulocyte count

Data type

boolean

Alias
UMLS CUI [1]
C0857490
iv. platelet count =/>75 x 10^3/mm^3
Description

Platelet count

Data type

boolean

Alias
UMLS CUI [1]
C0032181
e. adequate renal function (serum creatinine ≤ 2mg/dl)
Description

Serum creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. presence of central nervous system (cns) lymphoma
Description

CNS lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0280803
2. chronic lymphocytic leukemia (cll)
Description

CLL

Data type

boolean

Alias
UMLS CUI [1]
C0023434
3. small lymphocytic lymphoma
Description

Small lymphocytic lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0855095
4. therapy in prior 3 weeks (6 weeks for nitrosourea; 6 months for bone marrow transplantation (bmt))
Description

Therapy start date

Data type

boolean

Alias
UMLS CUI [1]
C2114713
5. patients who received prior rituximab or other anti-cd20 therapy
Description

Rituximab or other anti-cd20 therapy

Data type

boolean

Alias
UMLS CUI [1]
C0393022
UMLS CUI [2]
C3891557
6. serious non-malignant disease, or other malignancy
Description

Malignancies

Data type

boolean

Alias
UMLS CUI [1]
C0006826
7. active infection
Description

Infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
8. history of hiv infection
Description

HIV infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
i pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Lymphoma NCT01939730

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT01939730
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Follicular b-cell lymphoma: Disease status
Item
1. histologically confirmed follicular b-cell lymphoma. this can include relapsed patients, who have had no prior rituximab therapy, or previously untreated patients. previously untreated patients should be made aware of higher priority protocols such as combination chemo-immunotherapy protocols, but if they decline that, they can be entered on this protocol.
boolean
C0024301 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C0393022 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
C0332155 (UMLS CUI [4])
Patient status
Item
2. males or females, 18 years or older; expected survival of =/> 4 months; performance status of 0, 1 or 2.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0023671 (UMLS CUI [3])
C1518965 (UMLS CUI [4])
Monoclonal cluster of differentiation cd20-positive b-cells
Item
3. demonstrable monoclonal cluster of differentiation antigen 20 (cd20)-positive b-cell population.
boolean
C0746619 (UMLS CUI [1,1])
C0054946 (UMLS CUI [1,2])
C0004561 (UMLS CUI [1,3])
Hematologic function
Item
4. acceptable hematologic status including:
boolean
C0221130 (UMLS CUI [1])
Hemoglobin
Item
i. hemoglobin (hgb) =/> 8.0 gm/dl
boolean
C0518015 (UMLS CUI [1])
White blood count
Item
ii. white blood count (wbc) =/> 3.0 x 10^3/mm^3(x 10^9/l)
boolean
C0023508 (UMLS CUI [1])
Absolute granulocyte count
Item
iii. absolute granulocyte count =/> 1.5 x 10^3/mm^3
boolean
C0857490 (UMLS CUI [1])
Platelet count
Item
iv. platelet count =/>75 x 10^3/mm^3
boolean
C0032181 (UMLS CUI [1])
Serum creatinine
Item
e. adequate renal function (serum creatinine ≤ 2mg/dl)
boolean
C0201976 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
CNS lymphoma
Item
1. presence of central nervous system (cns) lymphoma
boolean
C0280803 (UMLS CUI [1])
CLL
Item
2. chronic lymphocytic leukemia (cll)
boolean
C0023434 (UMLS CUI [1])
Small lymphocytic lymphoma
Item
3. small lymphocytic lymphoma
boolean
C0855095 (UMLS CUI [1])
Therapy start date
Item
4. therapy in prior 3 weeks (6 weeks for nitrosourea; 6 months for bone marrow transplantation (bmt))
boolean
C2114713 (UMLS CUI [1])
Rituximab or other anti-cd20 therapy
Item
5. patients who received prior rituximab or other anti-cd20 therapy
boolean
C0393022 (UMLS CUI [1])
C3891557 (UMLS CUI [2])
Malignancies
Item
6. serious non-malignant disease, or other malignancy
boolean
C0006826 (UMLS CUI [1])
Infection
Item
7. active infection
boolean
C0009450 (UMLS CUI [1])
HIV infection
Item
8. history of hiv infection
boolean
C0019693 (UMLS CUI [1])
Pregnancy
Item
i pregnancy
boolean
C0032961 (UMLS CUI [1])
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