Eligibility Lymphoma NCT00446095

1 Formulários

StudyEvent: Eligibility
1. Eligibility Lymphoma NCT00446095

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

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])

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])

Exclusion Criteria

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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Eligibility Lymphoma NCT00446095