Hodgkin Disease | Lymphoma, Non-Hodgkin
Item
1. histologically confirmed hodgkin or non hodgkin's lymphoma
boolean
C0019829 (UMLS CUI [1])
C0024305 (UMLS CUI [2])
Recurrent disease Post Standard of Care | Refractory Disease Post Standard of Care | Absence Conventional Treatment Curative
Item
2. relapsed or refractory after standard treatments and with no curative option with conventional therapy
boolean
C0277556 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C2936643 (UMLS CUI [1,3])
C1514815 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C2936643 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C2945704 (UMLS CUI [3,2])
C1276305 (UMLS CUI [3,3])
Absence Brain Involvement with Lymphoma | Absence Meninges Involvement with Lymphoma
Item
3. no evidence of cerebral or meningeal involvement by lymphoma
boolean
C0332197 (UMLS CUI [1,1])
C0006104 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0024299 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C0025285 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
C0024299 (UMLS CUI [2,4])
Age
Item
4. age >= 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
5. eastern cooperative oncology group (ecog) performance status 0 to 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
6. life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
7. signed informed consent form prior to enrollment
boolean
C0021430 (UMLS CUI [1])
Laboratory criteria | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Involvement with Lymphoma | Serum total bilirubin measurement
Item
8. patients must meet the following laboratory criteria: aspartate aminotransferase (ast)/serum glutamate oxaloacetate transaminase (sgot) and alt/serum glutamate pyruvate transaminase (sgpt) </= 2.5 * upper limit of normal (uln) ) or </= 5.0 x uln if the transaminase elevation is due to lymphoma involvement, serum bilirubin </= 1.5
boolean
C0022877 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C1314939 (UMLS CUI [4,1])
C0024299 (UMLS CUI [4,2])
C1278039 (UMLS CUI [5])
Creatinine measurement, serum
Item
* uln, serum creatinine </=1.5 * uln free t4 within normal limits (wnl) (patients may be on thyroid hormone replacement)
boolean
C0201976 (UMLS CUI [1])
Disease Site Measurable Quantity
Item
9. patients must have at least one measurable site of disease
boolean
C0012634 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1513040 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement
Item
10. adequate bone marrow function as shown by: absolute neutrophil count (anc) >/= 1.0 x 109/l, platelets >/=100 x 109/l
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Fasting cholesterol level
Item
11. fasting serum cholesterol </=300 mg/dl or </=7.75 mmol/l and fasting triglycerides </= 2.5 * uln. note: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication 24 hours before starting therapy.
boolean
C1282513 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative
Item
12. women of childbearing potential (wocbp) must have a negative serum pregnancy test within 7 days of the first administration of study drug
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Burkitt Lymphoma | Lymphoblastic lymphoma | Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma allowed
Item
1. burkitt's lymphoma, lymphoblastic lymphoma, chronic lymphocytic leukemia (small lymphocytic lymphoma may be included)
boolean
C0006413 (UMLS CUI [1])
C0079748 (UMLS CUI [2])
C0023434 (UMLS CUI [3])
C0855095 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
Chemotherapy | Therapeutic radiology procedure | Investigational New Drugs
Item
2. chemotherapy or radiation therapy or other investigational agents within 4 weeks prior to entering the study
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Radioimmunotherapy
Item
3. previous radioimmunotherapy within 12 weeks
boolean
C0085101 (UMLS CUI [1])
Histone Deacetylase | mTOR Inhibitors | temsirolimus | Vorinostat
Item
4. prior therapy with hdac or [1] mammalian target of rapamycin (mtor) inhibitors i.e. temsirolimus, vorinostat (the list is not inclusive of investigational agents in these classes of drugs)
boolean
C0019643 (UMLS CUI [1])
C1515672 (UMLS CUI [2])
C1707080 (UMLS CUI [3])
C0672708 (UMLS CUI [4])
HIV Infection
Item
5. patient with known hiv infection
boolean
C0019693 (UMLS CUI [1])
Viral hepatitis
Item
6. known active viral hepatitis
boolean
C0042721 (UMLS CUI [1])
Disease Serious Interferes with Safety | Comorbidity Interferes with Safety | Disease Serious Interferes with Protocol Compliance | Comorbidity Interferes with Protocol Compliance
Item
7. any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0036043 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0036043 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0525058 (UMLS CUI [3,4])
C0009488 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
Decreased cardiac function | ECG: corrected QTc interval | Congenital long QT syndrome | Sustained ventricular tachycardia | Ventricular Fibrillation | Torsades de Pointes | Heart rate | Artificial cardiac pacemaker
Item
8. impaired cardiac function including any one of the following: • screening ecg with a corrected qt interval (qtc) > 450 msec confirmed by the investigator prior to enrollment to the study • patients with congenital long qt syndrome • history of sustained ventricular tachycardia • any history of ventricular fibrillation or torsades de pointes • bradycardia defined as heart rate < 50 beats per minute. patients with a pacemaker and heart rate >= 50 beats per minute are eligible.
boolean
C0232166 (UMLS CUI [1])
C2216079 (UMLS CUI [2])
C1141890 (UMLS CUI [3])
C0750197 (UMLS CUI [4])
C0042510 (UMLS CUI [5])
C0040479 (UMLS CUI [6])
C0018810 (UMLS CUI [7])
C0030163 (UMLS CUI [8])
Decreased cardiac function | Myocardial Infarction | Angina, Unstable | Congestive heart failure New York Heart Association Classification | Right bundle branch block | Left anterior fascicular block | Bifascicular block | Uncontrolled hypertension
Item
9. impaired cardiac function including any one of the following continued: • patients with a myocardial infarction or unstable angina within 6 months from registration on study • congestive heart failure (ny heart association class iii or iv) • right bundle branch block and left anterior hemiblock (bifascicular block) • uncontrolled hypertension
boolean
C0232166 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0018802 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
C0085615 (UMLS CUI [5])
C0264912 (UMLS CUI [6])
C0264914 (UMLS CUI [7])
C1868885 (UMLS CUI [8])
Pharmaceutical Preparations At risk Torsades de Pointes
Item
10. concomitant use of drugs with a risk of causing torsades de pointes
boolean
C0013227 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0040479 (UMLS CUI [1,3])
Diarrhea Resolution Lacking CTCAE Grades
Item
11. patients with unresolved diarrhea common toxicity criteria for adverse effects (ctcae) grade 1
boolean
C0011991 (UMLS CUI [1,1])
C1514893 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C1516728 (UMLS CUI [1,4])
Abnormal digestive tract function | Gastrointestinal Disease Changing Drug absorption | Panobinostat Oral Product | Everolimus Oral Tablet
Item
12. impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of oral panobinostat or everolimus.
boolean
C0232459 (UMLS CUI [1])
C0017178 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0678745 (UMLS CUI [2,3])
C3893181 (UMLS CUI [3])
C2682853 (UMLS CUI [4])
Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods Absent | Contraception, Barrier | Hormonal contraception Solitary Unacceptable
Item
13. female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. if barrier contraceptives are being used, these must be continued throughout the trial by both sexes. hormonal contraceptives are not acceptable as a sole method of contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C4034483 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0004764 (UMLS CUI [4])
C2985296 (UMLS CUI [5,1])
C0205171 (UMLS CUI [5,2])
C1883420 (UMLS CUI [5,3])
Gender | Sexual Partners Childbearing Potential Contraceptive methods Absent
Item
14. male patients whose sexual partners are wocbp not using effective birth control
boolean
C0079399 (UMLS CUI [1])
C0036911 (UMLS CUI [2,1])
C3831118 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0332197 (UMLS CUI [2,4])
Cancer Other Primary | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin | Exception Prostate carcinoma Early stage
Item
15. patients with a history of another primary malignancy within 5 years other than curatively treated cis of the cervix, basal or squamous cell carcinoma of the skin, or early stage prostate carcinoma.
boolean
C1707251 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0851140 (UMLS CUI [2,3])
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])
C0553723 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0600139 (UMLS CUI [5,2])
C2363430 (UMLS CUI [5,3])
HIV Seropositivity | Hepatitis C positive
Item
16. patients with known positivity for human immunodeficiency virus (hiv) ) or hepatitis c; baseline testing for hiv and hepatitis c is not required
boolean
C0019699 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
Compliance behavior to medical regimen Lacking | Informed Consent Unable
Item
17. patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent
boolean
C4039237 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
CORTICOSTEROIDS FOR SYSTEMIC USE chronic | Immunosuppressive Agents Systemic chronic | Exception Adrenal Cortex Hormones Dosage Daily | Prednisone Dosage Equivalent | Topical corticosteroids allowed | Adrenal Cortex Hormones Inhalation allowed
Item
18. patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent, except corticosteroids with a daily dosage equivalent to prednisone <= 20 mg. topical or inhaled corticosteroids are allowed.
boolean
C3653708 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0021081 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0001617 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0332173 (UMLS CUI [3,4])
C0032952 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205163 (UMLS CUI [4,3])
C0304604 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C0001617 (UMLS CUI [6,1])
C0205535 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
Immunization Attenuated Vaccines
Item
19. patients should not receive immunization with attenuated live vaccines within one week of study registration or during study period
boolean
C0020971 (UMLS CUI [1,1])
C0042211 (UMLS CUI [1,2])
Chronic Obstructive Airway Disease Treatment required for | Asthma Treatment required for
Item
20. chronic obstructive pulmonary disease (copd) or asthma requiring therapy
boolean
C0024117 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0004096 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
Diabetic - poor control | Elevated fasting glucose
Item
21. uncontrolled diabetes as defined by fasting serum glucose >1.5 x uln
boolean
C0421258 (UMLS CUI [1])
C1260439 (UMLS CUI [2])
Communicable Disease Severe Uncontrolled | Communicable Disease Severe Uncontrolled chronic | Requirement Antibiotics Oral | Requirement Antibiotics Intravenous
Item
22. active (acute or chronic) uncontrolled severe infection, requiring oral or intravenous antibiotics.
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
C0205191 (UMLS CUI [2,4])
C1514873 (UMLS CUI [3,1])
C0003232 (UMLS CUI [3,2])
C1527415 (UMLS CUI [3,3])
C1514873 (UMLS CUI [4,1])
C0003232 (UMLS CUI [4,2])
C1522726 (UMLS CUI [4,3])
Study Subject Participation Status | Therapeutic procedure
Item
23. patients receiving treatment on another clinical research trial.
boolean
C2348568 (UMLS CUI [1])
C0087111 (UMLS CUI [2])