Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma | T-Cell Prolymphocytic Leukemia
Item
1. diagnosis of cll, small lymphocytic lymphoma (sll), or -cell prolymphocytic leukemia (t-pll).
boolean
C0023434 (UMLS CUI [1])
C0855095 (UMLS CUI [2])
C2363142 (UMLS CUI [3])
Chemotherapy | Monoclonal Antibody Therapy
Item
2. previously treated with chemotherapy or monoclonal antibodies.
boolean
C0392920 (UMLS CUI [1])
C0279694 (UMLS CUI [2])
Rai Staging System | Indication Quantity Therapeutic procedure | splenomegaly massive | Splenomegaly Progressive | Lymph nodes Massive | Lymph nodes Cluster | Lymphadenopathy Progressive | Fatigue Grade | Fever Degrees fahrenheit | Night sweats Without Infection | Weight decreased | Lymphocytosis Progressive | Lymphocyte count increased | Lymphocyte Doubling Time
Item
3. all patients with rai stage iii-iv are eligible. - or - patients with rai stage 0-ii who meet one or more indication for treatment as defined by the nci-sponsored working group are eligible:massive or progressive splenomegaly; massive lymph nodes, nodal clusters, or progressive lymphadenopathy; grade 2 or 3 fatigue, fever >/= 100.5 degrees f, night sweats for > 2 weeks w/o documented infection, presence of weight loss >/= 10% over the preceding 6 months; progressive lymphocytosis with increase in lymphocyte count of >/= 50% over a 2-month period or an anticipated doubling time of < 6 months.
boolean
C1514715 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0241231 (UMLS CUI [3])
C0038002 (UMLS CUI [4,1])
C0205329 (UMLS CUI [4,2])
C0024204 (UMLS CUI [5,1])
C0522501 (UMLS CUI [5,2])
C0024204 (UMLS CUI [6,1])
C1704332 (UMLS CUI [6,2])
C0497156 (UMLS CUI [7,1])
C0205329 (UMLS CUI [7,2])
C0015672 (UMLS CUI [8,1])
C0441800 (UMLS CUI [8,2])
C0015967 (UMLS CUI [9,1])
C0456628 (UMLS CUI [9,2])
C0028081 (UMLS CUI [10,1])
C0332288 (UMLS CUI [10,2])
C3714514 (UMLS CUI [10,3])
C1262477 (UMLS CUI [11])
C0024282 (UMLS CUI [12,1])
C0205329 (UMLS CUI [12,2])
C0853698 (UMLS CUI [13])
C0024264 (UMLS CUI [14,1])
C2986483 (UMLS CUI [14,2])
Serum total bilirubin measurement | Creatinine measurement, serum | Abnormality Due to Chronic Lymphocytic Leukemia
Item
4. serum bilirubin less than 2mg/dl, serum creatinine less than 2mg/dl unless abnormality is considered due to cll by investigator.
boolean
C1278039 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C1704258 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0023434 (UMLS CUI [3,3])
ECOG performance status
Item
5. the eastern cooperative oncology group (ecog) performance status < 3.
boolean
C1520224 (UMLS CUI [1])
Informed Consent | Compliance behavior
Item
6. patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
boolean
C0021430 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
Sexually active Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy test negative | Pregnancy test positive Prevention Investigational New Drugs | Pregnancy test positive Study Subject Participation Status Exclusion | Gender Contraceptive methods
Item
7. sexually active women of childbearing potential must use birth control during study in manner that risk of failure is minimized. prior to study enrollment women of childbearing potential must be advised of importance of avoiding pregnancy during trial and potential risk factors for unintentional pregnancy. must have negative pregnancy test. if pregnancy test is positive patient must not receive investigational product and must not be enrolled in study. men enrolled on study should understand risks to sexual partner of childbearing potential and practice effective birth control.
boolean
C0241028 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
C0240802 (UMLS CUI [3,1])
C2700409 (UMLS CUI [3,2])
C0013230 (UMLS CUI [3,3])
C0240802 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C2828389 (UMLS CUI [4,3])
C0079399 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
Gender | Minorities
Item
8. inclusion of women and minorities: as per nih policy, women and members of minorities will be included in this protocol as they are referred in the relevant populations. there are no exclusions of women or minorities based on the study objectives.
boolean
C0079399 (UMLS CUI [1])
C0026192 (UMLS CUI [2])
New York Heart Association Classification
Item
9. new york heart association (nyha) class < 3
boolean
C1275491 (UMLS CUI [1])
Informed Consent
Item
10. patients must sign informed consent.
boolean
C0021430 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
1. pregnant or breast-feeding women are excluded.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Therapeutic radiology procedure Localized | Bone Marrow function Intact | Hematopoietic Growth Factors | Erythropoietin | Granulocyte Colony-Stimulating Factor | Granulocyte-Macrophage Colony-Stimulating Factor
Item
2. patients may not receive concurrent chemotherapy, radiotherapy, or immunotherapy. localized radiotherapy to an area not compromising bone marrow function does not apply, nor do hematopoietic growth factors such as erythropoietin, g-csf, gm-csf etc.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C1522449 (UMLS CUI [4,1])
C0392752 (UMLS CUI [4,2])
C0005953 (UMLS CUI [5,1])
C0031843 (UMLS CUI [5,2])
C0205266 (UMLS CUI [5,3])
C0079490 (UMLS CUI [6])
C0014822 (UMLS CUI [7])
C0079459 (UMLS CUI [8])
C0079460 (UMLS CUI [9])
Life-threatening infection Untreated | Life-threatening infection Uncontrolled
Item
3. patients must not have untreated or uncontrolled life-threatening infection.
boolean
C1859430 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1859430 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Angina Pectoris Uncontrolled | Congenital long QT syndrome | Congenital long QT syndrome Suspected | Ventricular arrhythmia | Prolonged QTc interval | Uncontrolled hypertension | Blood Coagulation Disorder Without Malignant Neoplasm | Pharmaceutical Preparations Causing Torsades de Pointes
Item
4. uncontrolled angina within 3 months; diagnosed or suspected congenital long qt syndrome; any history of clinically significant ventricular arrhythmias; prolonged qtc interval (> 450 msec); uncontrolled hypertension; significant bleeding disorder unrelated to cancer; patients currently taking drugs that are generally accepted to have a risk of causing torsades de pointes.
boolean
C0002962 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1141890 (UMLS CUI [2])
C1141890 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0085612 (UMLS CUI [4])
C1560305 (UMLS CUI [5])
C1868885 (UMLS CUI [6])
C0005779 (UMLS CUI [7,1])
C0332288 (UMLS CUI [7,2])
C0006826 (UMLS CUI [7,3])
C0013227 (UMLS CUI [8,1])
C0678227 (UMLS CUI [8,2])
C0040479 (UMLS CUI [8,3])
Pharmaceutical Preparations Inhibiting Platelet function | Aspirin | Dipyridamole | Epoprostenol | eptifibatide | clopidogrel | cilostazol | abciximab | Ticlopidine | Anti-Inflammatory Agents, Non-Steroidal | Anticoagulants | Warfarin | Heparin | Heparin, Low-Molecular-Weight | danaparoid | Dalteparin | tinzaparin | Enoxaparin
Item
5. medications that inhibit platelet function (i.e., aspirin, dipyridamole, epoprostenol, eptifibatide, clopidogrel, cilostazol, abciximab, ticlopidine, and any non-steroidal anti-inflammatory drug) or anticoagulants (warfarin, heparin/low molecular weight heparin [e.g., danaparoid, dalteparin, tinzaparin, enoxaparin]).
boolean
C0013227 (UMLS CUI [1,1])
C3463820 (UMLS CUI [1,2])
C1254881 (UMLS CUI [1,3])
C0004057 (UMLS CUI [2])
C0012582 (UMLS CUI [3])
C0033567 (UMLS CUI [4])
C0253563 (UMLS CUI [5])
C0070166 (UMLS CUI [6])
C0055729 (UMLS CUI [7])
C0288672 (UMLS CUI [8])
C0040207 (UMLS CUI [9])
C0003211 (UMLS CUI [10])
C0003280 (UMLS CUI [11])
C0043031 (UMLS CUI [12])
C0019134 (UMLS CUI [13])
C0019139 (UMLS CUI [14])
C0259507 (UMLS CUI [15])
C0206461 (UMLS CUI [16])
C0216278 (UMLS CUI [17])
C0206460 (UMLS CUI [18])