ID

30354

Beschreibung

Efficacy and Safety Study of Fostamatinib Tablets to Treat B-cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00446095

Link

https://clinicaltrials.gov/show/NCT00446095

Stichworte

Versionen (1)
  1. 29.05.18 29.05.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

29. Mai 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00446095

Englisch

Eligibility Lymphoma NCT00446095

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00446095
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must be > 18 years old.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. patients must be willing and able to give written informed consent by signing an irb-approved informed consent form prior to admission to this study and must fully understand the requirements of the study and be willing to comply with all study visits and assessments.
Beschreibung

Informed Consent | Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
3. patients with relapsed/refractory b-cell malignancy, (dlbcl, follicular lymphoma, mantle cell lymphoma, malt lymphoma, marginal zone lymphoma, cll or sll), who have failed at least one prior treatment regimen and for whom no standard therapy exists; patients who are intolerant of standard therapy or who are not candidates for available standard therapy may also be included.
Beschreibung

B-cell Malignant Neoplasms Recurrent | B-cell Malignant Neoplasms Refractory | Diffuse Large B-Cell Lymphoma | Lymphoma, Follicular | Mantle cell lymphoma | MALT Lymphoma | Marginal Zone B-Cell Lymphoma | Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma | Prior Therapy Quantity failed | Standard of Care Absent | Intolerance Standard of Care | Patients Inappropriate Standard of Care

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004561
UMLS CUI [1,2]
C0006826
UMLS CUI [1,3]
C0277556
UMLS CUI [2,1]
C0004561
UMLS CUI [2,2]
C0006826
UMLS CUI [2,3]
C0205269
UMLS CUI [3]
C0079744
UMLS CUI [4]
C0024301
UMLS CUI [5]
C0334634
UMLS CUI [6]
C0242647
UMLS CUI [7]
C1367654
UMLS CUI [8]
C0023434
UMLS CUI [9]
C0855095
UMLS CUI [10,1]
C1514463
UMLS CUI [10,2]
C1265611
UMLS CUI [10,3]
C0231175
UMLS CUI [11,1]
C2936643
UMLS CUI [11,2]
C0332197
UMLS CUI [12,1]
C0231199
UMLS CUI [12,2]
C2936643
UMLS CUI [13,1]
C0030705
UMLS CUI [13,2]
C1548788
UMLS CUI [13,3]
C2936643
4. patients must have measurable disease.
Beschreibung

Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
5. patients may be male or female. men, if sexually active, must agree to use at least one medically acceptable form of birth control for the duration of the study and for 30 days thereafter. sexually active women of childbearing potential must have a negative serum pregnancy test, and agree to use two independent methods of birth control for the duration of the study and for 30 days thereafter.
Beschreibung

Gender Sexually active Contraceptive methods Quantity | Childbearing Potential Sexually active Serum pregnancy test negative | Childbearing Potential Sexually active Contraceptive methods Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
UMLS CUI [1,4]
C1265611
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0241028
UMLS CUI [2,3]
C0430061
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0241028
UMLS CUI [3,3]
C0700589
UMLS CUI [3,4]
C1265611
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with t-cell lymphoma or primary cns lymphoma
Beschreibung

T-Cell Lymphoma | Primary central nervous system lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0079772
UMLS CUI [2]
C0280803
2. patients with a history of malignancy other than lymphoma, except basal cell carcinoma of the skin and in situ cervical carcinoma, if < 2 years since curative treatment
Beschreibung

Cancer Other | Exception Lymphoma | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0024299
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0851140
3. chemotherapy within 4 weeks of day 1 of treatment (6 weeks for mitomycin c and nitrosoureas)
Beschreibung

Chemotherapy | Mitomycin | Nitrosourea

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0002475
UMLS CUI [3]
C0028210
4. antibody therapy or lymphoma vaccine therapy within 6 weeks of day 1
Beschreibung

Antibody therapy | Lymphoma Vaccine Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0281176
UMLS CUI [2,1]
C0024299
UMLS CUI [2,2]
C0042209
5. radiotherapy within 2 weeks of day 1, 4 weeks if to marrow-bearing sites (sternum, pelvis)
Beschreibung

Therapeutic radiology procedure Bone Marrow Site | Therapeutic radiology procedure Sternum | Radiotherapy to pelvis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C1515974
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0038293
UMLS CUI [3]
C1536155
6. any other investigational therapy within 4 weeks of day 1
Beschreibung

Therapies, Investigational

Datentyp

boolean

Alias
UMLS CUI [1]
C0949266
7. significant gastrointestinal disease (crohn's or ulcerative colitis) or major gastric or small bowel surgery
Beschreibung

Gastrointestinal Disease | Crohn Disease | Ulcerative Colitis | Operation on stomach Major | Operative procedure on small intestine Major

Datentyp

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0010346
UMLS CUI [3]
C0009324
UMLS CUI [4,1]
C0192398
UMLS CUI [4,2]
C0205164
UMLS CUI [5,1]
C0192571
UMLS CUI [5,2]
C0205164
8. difficulty swallowing or malabsorption
Beschreibung

Swallowing problem | Malabsorption

Datentyp

boolean

Alias
UMLS CUI [1]
C0392678
UMLS CUI [2]
C3714745
9. patients with bone marrow impairment: hgb < 9.0 g/dl; anc < 1500/μl; platelets < 75,000/μl
Beschreibung

Bone Marrow Impaired | Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0221099
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0032181
10. patients with impairment of renal function: creatinine > 2.0 g/dl
Beschreibung

Renal Insufficiency | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
11. patients with abnormal liver function: ast/alt > 3x uln (up to 5x uln with liver involvement); bilirubin > 1.5 mg/dl
Beschreibung

Liver Dysfunction | Aspartate aminotransferase increased | Alanine aminotransferase increased | Liver Involvement | Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
UMLS CUI [4,1]
C0023884
UMLS CUI [4,2]
C1314939
UMLS CUI [5]
C1278039
12. patients who have been treated with a cyp3a4 inducer/inhibitor within 1 week prior to day 1 or who are expected to require treatment with cyp3a4 inducer/inhibitor during the course of the study (appendix iv)
Beschreibung

CYP3A4 Inducer | CYP3A4 Inhibitor | CYP3A4 Inducer Expected | CYP3A4 Inhibitor Expected

Datentyp

boolean

Alias
UMLS CUI [1]
C3830625
UMLS CUI [2]
C3830624
UMLS CUI [3,1]
C3830625
UMLS CUI [3,2]
C1517001
UMLS CUI [4,1]
C3830624
UMLS CUI [4,2]
C1517001
13. patients with karnofsky performance status < 60% (appendix i)
Beschreibung

Karnofsky Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
14. patients whose life expectancy is < 3 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
15. patients who are known to be hiv positive
Beschreibung

HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
16. patients who have a history of any other significant medical or physical condition that might impair the patient's well being or preclude full participation in the study
Beschreibung

Medical condition Impairing Patient Health | Physical Condition Impairing Patient Health | Medical condition Study Subject Participation Status Limited | Physical Condition Study Subject Participation Status Limited

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C0030705
UMLS CUI [1,4]
C0018684
UMLS CUI [2,1]
C3714565
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C0030705
UMLS CUI [2,4]
C0018684
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C0439801
UMLS CUI [4,1]
C3714565
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C0439801
17. pregnant or nursing females
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
18. patients receiving systemic or chronic inhaled steroids, with the exception of intermittent dexamethasone for the treatment of emesis or intermittent steroid inhalers for exacerbations of asthma
Beschreibung

Inhaled steroids Systemic | Inhaled steroids chronic | Exception Dexamethasone Vomiting | Exception Steroid Inhaler Exacerbation of asthma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2065041
UMLS CUI [1,2]
C0205373
UMLS CUI [2,1]
C2065041
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0011777
UMLS CUI [3,3]
C0042963
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0038317
UMLS CUI [4,3]
C0021461
UMLS CUI [4,4]
C0349790
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Ähnliche Modelle

Eligibility Lymphoma NCT00446095

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00446095
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patients must be > 18 years old.
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Protocol Compliance
Item
2. patients must be willing and able to give written informed consent by signing an irb-approved informed consent form prior to admission to this study and must fully understand the requirements of the study and be willing to comply with all study visits and assessments.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
B-cell Malignant Neoplasms Recurrent | B-cell Malignant Neoplasms Refractory | Diffuse Large B-Cell Lymphoma | Lymphoma, Follicular | Mantle cell lymphoma | MALT Lymphoma | Marginal Zone B-Cell Lymphoma | Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma | Prior Therapy Quantity failed | Standard of Care Absent | Intolerance Standard of Care | Patients Inappropriate Standard of Care
Item
3. patients with relapsed/refractory b-cell malignancy, (dlbcl, follicular lymphoma, mantle cell lymphoma, malt lymphoma, marginal zone lymphoma, cll or sll), who have failed at least one prior treatment regimen and for whom no standard therapy exists; patients who are intolerant of standard therapy or who are not candidates for available standard therapy may also be included.
boolean
C0004561 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,3])
C0004561 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0205269 (UMLS CUI [2,3])
C0079744 (UMLS CUI [3])
C0024301 (UMLS CUI [4])
C0334634 (UMLS CUI [5])
C0242647 (UMLS CUI [6])
C1367654 (UMLS CUI [7])
C0023434 (UMLS CUI [8])
C0855095 (UMLS CUI [9])
C1514463 (UMLS CUI [10,1])
C1265611 (UMLS CUI [10,2])
C0231175 (UMLS CUI [10,3])
C2936643 (UMLS CUI [11,1])
C0332197 (UMLS CUI [11,2])
C0231199 (UMLS CUI [12,1])
C2936643 (UMLS CUI [12,2])
C0030705 (UMLS CUI [13,1])
C1548788 (UMLS CUI [13,2])
C2936643 (UMLS CUI [13,3])
Measurable Disease
Item
4. patients must have measurable disease.
boolean
C1513041 (UMLS CUI [1])
Gender Sexually active Contraceptive methods Quantity | Childbearing Potential Sexually active Serum pregnancy test negative | Childbearing Potential Sexually active Contraceptive methods Quantity
Item
5. patients may be male or female. men, if sexually active, must agree to use at least one medically acceptable form of birth control for the duration of the study and for 30 days thereafter. sexually active women of childbearing potential must have a negative serum pregnancy test, and agree to use two independent methods of birth control for the duration of the study and for 30 days thereafter.
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C3831118 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0430061 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0241028 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
Item Group
C0680251 (UMLS CUI)
T-Cell Lymphoma | Primary central nervous system lymphoma
Item
1. patients with t-cell lymphoma or primary cns lymphoma
boolean
C0079772 (UMLS CUI [1])
C0280803 (UMLS CUI [2])
Cancer Other | Exception Lymphoma | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix
Item
2. patients with a history of malignancy other than lymphoma, except basal cell carcinoma of the skin and in situ cervical carcinoma, if < 2 years since curative treatment
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0024299 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0007117 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0851140 (UMLS CUI [4,3])
Chemotherapy | Mitomycin | Nitrosourea
Item
3. chemotherapy within 4 weeks of day 1 of treatment (6 weeks for mitomycin c and nitrosoureas)
boolean
C0392920 (UMLS CUI [1])
C0002475 (UMLS CUI [2])
C0028210 (UMLS CUI [3])
Antibody therapy | Lymphoma Vaccine Therapy
Item
4. antibody therapy or lymphoma vaccine therapy within 6 weeks of day 1
boolean
C0281176 (UMLS CUI [1])
C0024299 (UMLS CUI [2,1])
C0042209 (UMLS CUI [2,2])
Therapeutic radiology procedure Bone Marrow Site | Therapeutic radiology procedure Sternum | Radiotherapy to pelvis
Item
5. radiotherapy within 2 weeks of day 1, 4 weeks if to marrow-bearing sites (sternum, pelvis)
boolean
C1522449 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0038293 (UMLS CUI [2,2])
C1536155 (UMLS CUI [3])
Therapies, Investigational
Item
6. any other investigational therapy within 4 weeks of day 1
boolean
C0949266 (UMLS CUI [1])
Gastrointestinal Disease | Crohn Disease | Ulcerative Colitis | Operation on stomach Major | Operative procedure on small intestine Major
Item
7. significant gastrointestinal disease (crohn's or ulcerative colitis) or major gastric or small bowel surgery
boolean
C0017178 (UMLS CUI [1])
C0010346 (UMLS CUI [2])
C0009324 (UMLS CUI [3])
C0192398 (UMLS CUI [4,1])
C0205164 (UMLS CUI [4,2])
C0192571 (UMLS CUI [5,1])
C0205164 (UMLS CUI [5,2])
Swallowing problem | Malabsorption
Item
8. difficulty swallowing or malabsorption
boolean
C0392678 (UMLS CUI [1])
C3714745 (UMLS CUI [2])
Bone Marrow Impaired | Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement
Item
9. patients with bone marrow impairment: hgb < 9.0 g/dl; anc < 1500/μl; platelets < 75,000/μl
boolean
C0005953 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0518015 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
Renal Insufficiency | Creatinine measurement, serum
Item
10. patients with impairment of renal function: creatinine > 2.0 g/dl
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Liver Dysfunction | Aspartate aminotransferase increased | Alanine aminotransferase increased | Liver Involvement | Serum total bilirubin measurement
Item
11. patients with abnormal liver function: ast/alt > 3x uln (up to 5x uln with liver involvement); bilirubin > 1.5 mg/dl
boolean
C0086565 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0023884 (UMLS CUI [4,1])
C1314939 (UMLS CUI [4,2])
C1278039 (UMLS CUI [5])
CYP3A4 Inducer | CYP3A4 Inhibitor | CYP3A4 Inducer Expected | CYP3A4 Inhibitor Expected
Item
12. patients who have been treated with a cyp3a4 inducer/inhibitor within 1 week prior to day 1 or who are expected to require treatment with cyp3a4 inducer/inhibitor during the course of the study (appendix iv)
boolean
C3830625 (UMLS CUI [1])
C3830624 (UMLS CUI [2])
C3830625 (UMLS CUI [3,1])
C1517001 (UMLS CUI [3,2])
C3830624 (UMLS CUI [4,1])
C1517001 (UMLS CUI [4,2])
Karnofsky Performance Status
Item
13. patients with karnofsky performance status < 60% (appendix i)
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
14. patients whose life expectancy is < 3 months
boolean
C0023671 (UMLS CUI [1])
HIV Seropositivity
Item
15. patients who are known to be hiv positive
boolean
C0019699 (UMLS CUI [1])
Medical condition Impairing Patient Health | Physical Condition Impairing Patient Health | Medical condition Study Subject Participation Status Limited | Physical Condition Study Subject Participation Status Limited
Item
16. patients who have a history of any other significant medical or physical condition that might impair the patient's well being or preclude full participation in the study
boolean
C3843040 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
C0018684 (UMLS CUI [1,4])
C3714565 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0030705 (UMLS CUI [2,3])
C0018684 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C3714565 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C0439801 (UMLS CUI [4,3])
Pregnancy | Breast Feeding
Item
17. pregnant or nursing females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Inhaled steroids Systemic | Inhaled steroids chronic | Exception Dexamethasone Vomiting | Exception Steroid Inhaler Exacerbation of asthma
Item
18. patients receiving systemic or chronic inhaled steroids, with the exception of intermittent dexamethasone for the treatment of emesis or intermittent steroid inhalers for exacerbations of asthma
boolean
C2065041 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C2065041 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0011777 (UMLS CUI [3,2])
C0042963 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0038317 (UMLS CUI [4,2])
C0021461 (UMLS CUI [4,3])
C0349790 (UMLS CUI [4,4])
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