Informed Consent
Item
1. understand and voluntarily sign an informed consent form.
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. age >/= 18 at the time of signing the informed consent form.
boolean
C0001779 (UMLS CUI [1])
Protocol Compliance
Item
3. able to adhere to the study visit schedule and other protocol requirements.
boolean
C0525058 (UMLS CUI [1])
Indolent Non-Hodgkin Lymphoma untreated Ann Arbor lymphoma staging system | Small Lymphocytic Lymphoma | Marginal Zone B-Cell Lymphoma | Follicular Lymphoma Ann Arbor lymphoma staging system | Prior radiation therapy Local disease
Item
4. untreated indolent non-hodgkin's lymphoma stage iii-iv including small lymphocytic lymphoma, marginal zone lymphoma, grade 1 or 2 follicular lymphoma. (prior radiation for localized disease allowed).
boolean
C1334170 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0432516 (UMLS CUI [1,3])
C0855095 (UMLS CUI [2])
C1367654 (UMLS CUI [3])
C0024301 (UMLS CUI [4,1])
C0432516 (UMLS CUI [4,2])
C0279134 (UMLS CUI [5,1])
C0277565 (UMLS CUI [5,2])
Measurable lesion Size Quantity
Item
5. at least one measurable lesion according to the international workshop standardized response criteria for non-hodgkin's lymphomas (iwg) greater than 1.5cm.
boolean
C1513041 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
ECOG performance status
Item
6. ecog performance status of </= 2 at study entry.
boolean
C1520224 (UMLS CUI [1])
Laboratory Results | Absolute neutrophil count | Platelet Count measurement | Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver
Item
7. laboratory test results within these ranges: absolute neutrophil count >/= 1.5 x 10^9/l; platelet count >/=100 x 10^9/l; serum creatinine </= 2.0 mg/dl; total bilirubin </=1.5 mg/dl; ast (sgot) and alt (sgpt) </=2 x uln or </=5 x uln if hepatic metastases are present.
boolean
C1254595 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201836 (UMLS CUI [7])
C0494165 (UMLS CUI [8])
Malignant Neoplasms Disease Free of | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Carcinoma in situ of female breast Treated | Exception Curative treatment Prostate carcinoma Localized
Item
8. disease free of prior malignancies for >/= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast, or localized prostate cancer treated with curative intent.
boolean
C0006826 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0332296 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0686288 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C1273390 (UMLS CUI [6,2])
C0600139 (UMLS CUI [6,3])
C0392752 (UMLS CUI [6,4])
Enrollment Risk Reduction Program | Protocol Compliance
Item
9. all study participants must be registered into the mandatory revassist® program, and be willing and able to comply with the requirements of revassist®.
boolean
C1516879 (UMLS CUI [1,1])
C1137094 (UMLS CUI [1,2])
C3484370 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Lenalidomide | Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods Quantity | Childbearing Potential Pregnancy Tests
Item
10. females of childbearing potential (fcbp) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 miu/ml within 10 -14 days prior to and again within 24 hours of prescribing lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 4 weeks before she starts taking lenalidomide. fcbp must also agree to ongoing pregnancy testing.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
C1144149 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0036899 (UMLS CUI [4,2])
C3831118 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
C3831118 (UMLS CUI [6,1])
C0032976 (UMLS CUI [6,2])
Gender Latex condom Coitus Childbearing Potential | Vasectomy
Item
11. men must agree to use a latex condom during sexual contact with a female of child bearing potential even if they have had a successful vasectomy.
boolean
C0079399 (UMLS CUI [1,1])
C3873750 (UMLS CUI [1,2])
C0009253 (UMLS CUI [1,3])
C3831118 (UMLS CUI [1,4])
C0042387 (UMLS CUI [2])
Bulky Disease | Aspirin U/day | Anticoagulation Therapy Prophylactic | Aspirin intolerance | Warfarin | Heparin, Low-Molecular-Weight
Item
12. for patients with bulky disease (tumors >5cm) must be able to take aspirin (81 mg or 325 mg) daily as prophylactic anticoagulation (patients intolerant to asa may use warfarin or low molecular weight heparin.
boolean
C1511341 (UMLS CUI [1])
C0004057 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0003281 (UMLS CUI [3,1])
C0199176 (UMLS CUI [3,2])
C0004059 (UMLS CUI [4])
C0043031 (UMLS CUI [5])
C0019139 (UMLS CUI [6])
Medical condition Serious Preventing Informed Consent | Laboratory test result abnormal Preventing Informed Consent | Mental disorders Preventing Informed Consent
Item
1. any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,4])
C0438215 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
2. pregnant or breast feeding females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Condition At risk Study Subject Participation Status | Laboratory test result abnormal At risk Study Subject Participation Status | Condition Interferes with Interpretation Study data | Laboratory test result abnormal Interferes with Interpretation Study data
Item
3. any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
boolean
C0348080 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0438215 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0459471 (UMLS CUI [3,3])
C0681873 (UMLS CUI [3,4])
C0438215 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0459471 (UMLS CUI [4,3])
C0681873 (UMLS CUI [4,4])
Chemotherapy | Therapies, Investigational
Item
4. use of any chemotherapy or experimental therapy within 28 days of enrollment.
boolean
C0392920 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
Hypersensitivity Thalidomide
Item
5. known hypersensitivity to thalidomide.
boolean
C0020517 (UMLS CUI [1,1])
C0039736 (UMLS CUI [1,2])
Erythema Nodosum | Rash desquamating | Use of Thalidomide | Intake Pharmaceutical Preparations Similar
Item
6. the development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
boolean
C0014743 (UMLS CUI [1])
C0542171 (UMLS CUI [2])
C1524063 (UMLS CUI [3,1])
C0039736 (UMLS CUI [3,2])
C1512806 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C2348205 (UMLS CUI [4,3])
Prior use of Lenalidomide
Item
7. any prior use of lenalidomide.
boolean
C2114648 (UMLS CUI [1,1])
C1144149 (UMLS CUI [1,2])
Antineoplastic Agents | Therapies, Investigational
Item
8. concurrent use of other anti-cancer agents or experimental treatments.
boolean
C0003392 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
Item
9. known positive for hiv or infectious hepatitis type b or c. (hepatitis b core antibody can be positive if hep b surface antigen is negative and no hbv dna in blood, indicating a cleared infection.)
boolean
C0019699 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C1112419 (UMLS CUI [3])