T-cell lymphoma recurrent | T-cell lymphoma refractory | Peripheral T-Cell Lymphoma | Angioimmunoblastic Lymphadenopathy | Anaplastic large B-cell lymphoma | Hepatosplenic T-cell lymphoma | Enteropathy-Associated T-Cell Lymphoma | Lymphoma, T-Cell, Cutaneous | Mycosis fungoides with systemic infiltration
Item
1. relapsed or refractory tcl status including diagnoses of peripheral tcl-nos, angioimmunoblastic tcl, anaplastic large cell lymphoma, hepatosplenic tcl, enteropathy-associated tcl, or mycosis fungoides(mf)/cutaneous tcl with transformation to systemic tcl.
boolean
C0854826 (UMLS CUI [1])
C0854827 (UMLS CUI [2])
C0079774 (UMLS CUI [3])
C0020981 (UMLS CUI [4])
C1321546 (UMLS CUI [5])
C1333984 (UMLS CUI [6])
C0456889 (UMLS CUI [7])
C0079773 (UMLS CUI [8])
C1275305 (UMLS CUI [9])
Chemotherapy Quantity | doxorubicin
Item
2. patients must have received at least one chemotherapy regimen which contained doxorubicin.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0013089 (UMLS CUI [2])
Measurable lesion 2-Dimensional Quantity | Bone Marrow T-Cell Lymphoma Positive
Item
3. at least one 1.5 cm bidimensional measurable lesion or bone marrow positivity of tcl.
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0005953 (UMLS CUI [2,1])
C0079772 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
ECOG performance status
Item
4. eastern cooperative oncology group (ecog) performance status </= 2.
boolean
C1520224 (UMLS CUI [1])
Absolute neutrophil count | Platelet Count measurement | Bone Marrow Negative T-Cell Lymphoma | Bone Marrow Positive T-Cell Lymphoma | Serum total bilirubin measurement | Gilbert Disease | Creatinine measurement, serum | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
5. lab criteria of absolute neutrophil count (anc) >/= 1000 cells/mm3, platelets >/= 80,000 cells/mm3 if baseline bone marrow negative for tcl involvement and platelets >/= 20,000 cells/mm3 if baseline bone marrow positive for tcl involvement, bilirubin </= 2 x upper limits of normal (uln) (gilbert's </= 3 x uln), creatinine </= 1.5 x uln, and alt and ast </= 3 x uln.
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C1513916 (UMLS CUI [3,2])
C0079772 (UMLS CUI [3,3])
C0005953 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
C0079772 (UMLS CUI [4,3])
C1278039 (UMLS CUI [5])
C0017551 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
C0201836 (UMLS CUI [8])
C0201899 (UMLS CUI [9])
Childbearing Potential Pregnancy test negative | Females & males of reproductive potential Contraceptive methods | Hormonal Contraception | Intrauterine Devices | Vaginal contraceptive diaphragm | Condoms | Spermatocidal Agents | Sexual Abstinence
Item
6. negative pregnancy test for females of childbearing potential within 7 days prior to start of treatment. patients of reproductive potential must follow accepted birth control methods which include hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence during treatment and for 3 months after completion of treatment.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C4034483 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C2985296 (UMLS CUI [3])
C0021900 (UMLS CUI [4])
C0042241 (UMLS CUI [5])
C0677582 (UMLS CUI [6])
C0037862 (UMLS CUI [7])
C0036899 (UMLS CUI [8])
Age
Item
7. age of >/= 18 years.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
8. voluntarily signed institutional review board (irb) approved informed consent document (icd) before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
boolean
C0021430 (UMLS CUI [1])
Cancer Other | Remission Absent | Exception Skin carcinoma | Exception Melanoma TNM clinical staging | Exception Prostate carcinoma Localized | Exception Cervical cancer In situ
Item
1. history of another malignancy not in remission for at least 2 yrs (except non-melanoma skin cancer, stage 0 melanoma, localized prostate cancer, cervical cancer in situ)
boolean
C1707251 (UMLS CUI [1])
C0687702 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0025202 (UMLS CUI [4,2])
C3258246 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0600139 (UMLS CUI [5,2])
C0392752 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C4048328 (UMLS CUI [6,2])
C0444498 (UMLS CUI [6,3])
Primary central nervous system lymphoma
Item
2. known active central nervous system (cns) lymphoma.
boolean
C0280803 (UMLS CUI [1])
Cardiac ejection fraction | Myocardial Infarction | Angina Pectoris Uncontrolled | Ventricular arrhythmia Severe Uncontrolled | ECG myocardial ischemia
Item
3. ejection fraction (ef) of < 40%, myocardial infarction (mi) within past 3 months, uncontrolled angina, severe uncontrolled ventricular arrythmias, or ecg evidence of acute ischemia.
boolean
C0232174 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002962 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0085612 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0205318 (UMLS CUI [4,3])
C0474715 (UMLS CUI [5])
Communicable Disease CTCAE Grades
Item
4. grade 3 infection within 2 weeks of first dose romidepsin plus ice.
boolean
C0009450 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
5. pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs Other
Item
6. receipt of another investigational drug within 14 days of enrollment.
boolean
C0013230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Allergic Reaction Investigational New Drugs | Allergic Reaction Investigational New Drug Component | Exception Podophyllum preparation | Exception povidone
Item
7. patients with previous hypersensitivity reactions to the study drugs and components (ex: podophyllum and povidone).
boolean
C1527304 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1110663 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0032856 (UMLS CUI [4,2])