ID

36297

Description

Optimal Dose Finding Study ABT-199 and Ibrutinib in MCL; ODM derived from: https://clinicaltrials.gov/show/NCT02419560

Link

https://clinicaltrials.gov/show/NCT02419560

Keywords

Versions (1)
  1. 4/30/19 4/30/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 30, 2019

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License

Creative Commons BY 4.0
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Eligibility Lymphoma, Mantle-Cell NCT02419560

English

Eligibility Lymphoma, Mantle-Cell NCT02419560

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosed with mantle cell lymphoma and has had at least one chemotherapy.
Description

Mantle cell lymphoma | Chemotherapy Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0334634
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1265611
2. subjects must have measurable or evaluable disease.
Description

Measurable Disease | Evaluable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
3. ecog performance status of 0-2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
4. must be referred for treatment with ibrutinib.
Description

Ibrutinib

Data type

boolean

Alias
UMLS CUI [1]
C3501358
5. must have adequate organ function.
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subject is pregnant.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
2. prior malignancy (except nonmelanomatous skin cancer) unless disease free for a minimum of 2 years; non-invasive conditions such as carcinoma in situ of the breast, oral cavity, or cervix are all permissible.
Description

Malignant Neoplasms | Exception Skin carcinoma | Exception Disease Free Duration | Carcinoma in situ of female breast allowed | Carcinoma in situ of oral cavity allowed | Carcinoma in situ of uterine cervix allowed

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0332296
UMLS CUI [3,4]
C0449238
UMLS CUI [4,1]
C0686288
UMLS CUI [4,2]
C0683607
UMLS CUI [5,1]
C0347073
UMLS CUI [5,2]
C0683607
UMLS CUI [6,1]
C0851140
UMLS CUI [6,2]
C0683607
3. known cns lymphoma.
Description

Central nervous system lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0742472
4. prior or current treatment with certain medications. talk to study contact for specifics.
Description

Pharmaceutical Preparations Specific

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205369
5. subject is at high risk for tls.
Description

High risk of Tumor Lysis Syndrome

Data type

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0041364
6. subject has malabsorption syndrome or other condition which may affect an enteral route of administration.
Description

Malabsorption Syndrome Affecting Enteral Route of Drug Administration | Condition Affecting Enteral Route of Drug Administration

Data type

boolean

Alias
UMLS CUI [1,1]
C0024523
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1522196
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C1522196
7. subject has known contraindication or allergy to both xanthine oxidase inhibitors and rasburicase.
Description

Medical contraindication Xanthine Oxidase Inhibitors | Xanthine oxidase inhibitor allergy | Medical contraindication Rasburicase | Hypersensitivity Rasburicase

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0302609
UMLS CUI [2]
C0571135
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0937932
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0937932
8. significant history of heart disease.
Description

Heart Disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
9. subject has an active infection.
Description

Communicable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009450
10. known active hepatitis b or hepatitis c.
Description

Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
11. a serious uncontrolled medical disorder that in the opinion of the investigator would impair the ability of the subject to receive protocol therapy.
Description

Disease Serious Uncontrolled | Therapy Receive Impaired

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C0221099
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Similar models

Eligibility Lymphoma, Mantle-Cell NCT02419560

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Mantle cell lymphoma | Chemotherapy Quantity
Item
1. diagnosed with mantle cell lymphoma and has had at least one chemotherapy.
boolean
C0334634 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Measurable Disease | Evaluable Disease
Item
2. subjects must have measurable or evaluable disease.
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
ECOG performance status
Item
3. ecog performance status of 0-2.
boolean
C1520224 (UMLS CUI [1])
Ibrutinib
Item
4. must be referred for treatment with ibrutinib.
boolean
C3501358 (UMLS CUI [1])
Organ function
Item
5. must have adequate organ function.
boolean
C0678852 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy
Item
1. subject is pregnant.
boolean
C0032961 (UMLS CUI [1])
Malignant Neoplasms | Exception Skin carcinoma | Exception Disease Free Duration | Carcinoma in situ of female breast allowed | Carcinoma in situ of oral cavity allowed | Carcinoma in situ of uterine cervix allowed
Item
2. prior malignancy (except nonmelanomatous skin cancer) unless disease free for a minimum of 2 years; non-invasive conditions such as carcinoma in situ of the breast, oral cavity, or cervix are all permissible.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
C0449238 (UMLS CUI [3,4])
C0686288 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
C0347073 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C0851140 (UMLS CUI [6,1])
C0683607 (UMLS CUI [6,2])
Central nervous system lymphoma
Item
3. known cns lymphoma.
boolean
C0742472 (UMLS CUI [1])
Pharmaceutical Preparations Specific
Item
4. prior or current treatment with certain medications. talk to study contact for specifics.
boolean
C0013227 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
High risk of Tumor Lysis Syndrome
Item
5. subject is at high risk for tls.
boolean
C0332167 (UMLS CUI [1,1])
C0041364 (UMLS CUI [1,2])
Malabsorption Syndrome Affecting Enteral Route of Drug Administration | Condition Affecting Enteral Route of Drug Administration
Item
6. subject has malabsorption syndrome or other condition which may affect an enteral route of administration.
boolean
C0024523 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1522196 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C1522196 (UMLS CUI [2,3])
Medical contraindication Xanthine Oxidase Inhibitors | Xanthine oxidase inhibitor allergy | Medical contraindication Rasburicase | Hypersensitivity Rasburicase
Item
7. subject has known contraindication or allergy to both xanthine oxidase inhibitors and rasburicase.
boolean
C1301624 (UMLS CUI [1,1])
C0302609 (UMLS CUI [1,2])
C0571135 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C0937932 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0937932 (UMLS CUI [4,2])
Heart Disease
Item
8. significant history of heart disease.
boolean
C0018799 (UMLS CUI [1])
Communicable Disease
Item
9. subject has an active infection.
boolean
C0009450 (UMLS CUI [1])
Hepatitis B | Hepatitis C
Item
10. known active hepatitis b or hepatitis c.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
Disease Serious Uncontrolled | Therapy Receive Impaired
Item
11. a serious uncontrolled medical disorder that in the opinion of the investigator would impair the ability of the subject to receive protocol therapy.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C0221099 (UMLS CUI [2,3])
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