ID

42631

Description

Ofatumumab for Minimal Residual Disease (MRD) and Maintenance Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01258933

Link

https://clinicaltrials.gov/show/NCT01258933

Keywords

Versions (2)
  1. 6/18/20 6/18/20 -
  2. 9/17/21 9/17/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT01258933

English

Eligibility Leukemia NCT01258933

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01258933
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of cd20+ chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll) treated with chemotherapy or chemoimmunotherapy: post-frontline therapy, patients must have non-progressing disease and be 4 months to 1 year post treatment. post-treatment for relapsed cll, eligible patients must have non-progressing disease and be 3 months to 1 year post treatment.
Description

CLL CD20 positive | Small Lymphocytic Lymphoma CD20 positive | Chemotherapy | Chemoimmunotherapy | Disease Progression Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C3888518
UMLS CUI [2,1]
C0855095
UMLS CUI [2,2]
C3888518
UMLS CUI [3]
C0392920
UMLS CUI [4]
C2986423
UMLS CUI [5,1]
C0242656
UMLS CUI [5,2]
C0332197
2. patients (cr, npr, or pr at enrollment) must have measurable disease, which may include mrd by 4-color flow cytometry.
Description

In complete remission | Nodular Partial Response | Partial response | Measurable Disease | Minimal residual disease Flow Cytometry

Data type

boolean

Alias
UMLS CUI [1]
C0677874
UMLS CUI [2]
C2347357
UMLS CUI [3]
C1521726
UMLS CUI [4]
C1513041
UMLS CUI [5,1]
C0242596
UMLS CUI [5,2]
C0016263
3. adequate renal and hepatic function (creatinine < 2 mg/dl, bilirubin < 2 mg/dl). patients with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the study chairman. patients with gilbert's syndrome are eligible.
Description

Renal function | Liver function | Creatinine measurement, serum | Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0201976
UMLS CUI [4]
C1278039
4. age >/= 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
5. ecog performance status of 0-2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
6. provide informed consent indicating patient is aware of the investigational nature of this study according to the policies of the mdacc irb.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
7. patients of childbearing potential (females who have not been postmenopausal for at least 12 consecutive months or who have not undergone previous surgical sterilization or males who have not been surgically sterilized) must be willing to practice birth control during the study.
Description

Females & males of reproductive potential Contraceptive methods | Gender | Postmenopausal state Absent | Female Sterilization Absent | Male sterilization Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0079399
UMLS CUI [3,1]
C0232970
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0015787
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0024559
UMLS CUI [5,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. positive serology for hepatitis b virus (hb) defined as a positive test for hbsag. in addition, if negative for hbsag but hbcab positive (regardless of hbsab status), a hb dna test will be performed and if positive the subject will be excluded.
Description

Serology positive Hepatitis B Virus | Serum Hepatitis B Surface Antigen Test Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0242089
UMLS CUI [1,2]
C0019169
UMLS CUI [2,1]
C1254699
UMLS CUI [2,2]
C1514241
2. concurrent chemotherapy, radiotherapy, or immunotherapy, including other monoclonal antibodies. localized radiotherapy to an area not comprising bone marrow function does not apply.
Description

Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Monoclonal Antibodies

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021083
UMLS CUI [4]
C0003250
3. active infection or significant medical illness, including current active hepatic or biliary disease (with exception of patients with asymptomatic gallstones, liver involved with cll or stable chronic liver disease per investigator assessment).
Description

Communicable Disease | Illness Significant | Liver disease | Biliary System Disorder | Exception Cholelithiasis Asymptomatic | Exception Liver Involvement with CLL | Exception Chronic liver disease Stable

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0750502
UMLS CUI [3]
C0023895
UMLS CUI [4]
C3275124
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0008350
UMLS CUI [5,3]
C0231221
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0023884
UMLS CUI [6,3]
C1314939
UMLS CUI [6,4]
C0023434
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0341439
UMLS CUI [7,3]
C0205360
4. pregnant and breastfeeding females are excluded.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Leukemia NCT01258933

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01258933
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
CLL CD20 positive | Small Lymphocytic Lymphoma CD20 positive | Chemotherapy | Chemoimmunotherapy | Disease Progression Absent
Item
1. diagnosis of cd20+ chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll) treated with chemotherapy or chemoimmunotherapy: post-frontline therapy, patients must have non-progressing disease and be 4 months to 1 year post treatment. post-treatment for relapsed cll, eligible patients must have non-progressing disease and be 3 months to 1 year post treatment.
boolean
C0023434 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])
C0855095 (UMLS CUI [2,1])
C3888518 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3])
C2986423 (UMLS CUI [4])
C0242656 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
In complete remission | Nodular Partial Response | Partial response | Measurable Disease | Minimal residual disease Flow Cytometry
Item
2. patients (cr, npr, or pr at enrollment) must have measurable disease, which may include mrd by 4-color flow cytometry.
boolean
C0677874 (UMLS CUI [1])
C2347357 (UMLS CUI [2])
C1521726 (UMLS CUI [3])
C1513041 (UMLS CUI [4])
C0242596 (UMLS CUI [5,1])
C0016263 (UMLS CUI [5,2])
Renal function | Liver function | Creatinine measurement, serum | Serum total bilirubin measurement
Item
3. adequate renal and hepatic function (creatinine < 2 mg/dl, bilirubin < 2 mg/dl). patients with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the study chairman. patients with gilbert's syndrome are eligible.
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
Age
Item
4. age >/= 18 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
5. ecog performance status of 0-2.
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
6. provide informed consent indicating patient is aware of the investigational nature of this study according to the policies of the mdacc irb.
boolean
C0021430 (UMLS CUI [1])
Females & males of reproductive potential Contraceptive methods | Gender | Postmenopausal state Absent | Female Sterilization Absent | Male sterilization Absent
Item
7. patients of childbearing potential (females who have not been postmenopausal for at least 12 consecutive months or who have not undergone previous surgical sterilization or males who have not been surgically sterilized) must be willing to practice birth control during the study.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
C0232970 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0015787 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0024559 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Serology positive Hepatitis B Virus | Serum Hepatitis B Surface Antigen Test Positive
Item
1. positive serology for hepatitis b virus (hb) defined as a positive test for hbsag. in addition, if negative for hbsag but hbcab positive (regardless of hbsab status), a hb dna test will be performed and if positive the subject will be excluded.
boolean
C0242089 (UMLS CUI [1,1])
C0019169 (UMLS CUI [1,2])
C1254699 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Monoclonal Antibodies
Item
2. concurrent chemotherapy, radiotherapy, or immunotherapy, including other monoclonal antibodies. localized radiotherapy to an area not comprising bone marrow function does not apply.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0003250 (UMLS CUI [4])
Communicable Disease | Illness Significant | Liver disease | Biliary System Disorder | Exception Cholelithiasis Asymptomatic | Exception Liver Involvement with CLL | Exception Chronic liver disease Stable
Item
3. active infection or significant medical illness, including current active hepatic or biliary disease (with exception of patients with asymptomatic gallstones, liver involved with cll or stable chronic liver disease per investigator assessment).
boolean
C0009450 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0023895 (UMLS CUI [3])
C3275124 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0008350 (UMLS CUI [5,2])
C0231221 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0023884 (UMLS CUI [6,2])
C1314939 (UMLS CUI [6,3])
C0023434 (UMLS CUI [6,4])
C1705847 (UMLS CUI [7,1])
C0341439 (UMLS CUI [7,2])
C0205360 (UMLS CUI [7,3])
Pregnancy | Breast Feeding
Item
4. pregnant and breastfeeding females are excluded.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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