Lymphoma, Follicular | Marginal Zone Lymphoma
Item
1. histologically or cytologically confirmed follicular or marginal zone lymphoma
boolean
C0024301 (UMLS CUI [1])
C1367654 (UMLS CUI [2])
Refractory Disease | Evaluable Disease Persistent post treatment | Recurrent disease | Prior Therapy Quantity
Item
2. refractory disease defined as persistence of evaluable disease after therapy or have relapsed disease to at least one prior treatment regimen
boolean
C1514815 (UMLS CUI [1])
C1516986 (UMLS CUI [2,1])
C0205322 (UMLS CUI [2,2])
C2709088 (UMLS CUI [2,3])
C0277556 (UMLS CUI [3])
C1514463 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Informed Consent
Item
3. understand and voluntarily sign an informed consent form
boolean
C0021430 (UMLS CUI [1])
Age
Item
4. age > or = to 18 years
boolean
C0001779 (UMLS CUI [1])
Protocol Compliance
Item
5. able to adhere to the study requirements
boolean
C0525058 (UMLS CUI [1])
Availability of Tumor tissue sample Frozen | Microarray Analysis
Item
6. a frozen tumor sample must be available for microarray analysis. this may either be a previously collected sample if it was properly prepared or a new biopsy may be obtained.
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0016701 (UMLS CUI [1,3])
C1449575 (UMLS CUI [2])
Specimen obtained by core needle biopsy | Leukapheresis Acceptable | White Blood Cell Count procedure
Item
o at least 1 core biopsy specimen using at least a 16 gauge needle, which corresponds to roughly 25 mg of tissue. an equivalent amount of biopsy material from previously performed procedures, as long as it was fresh frozen, can be used. sample obtained with leukapheresis is acceptable in subjects with a white blood cell count (wbc) of 100,000 or greater.
boolean
C1960700 (UMLS CUI [1])
C0023416 (UMLS CUI [2,1])
C1879533 (UMLS CUI [2,2])
C0023508 (UMLS CUI [3])
ECOG performance status
Item
7. eastern cooperative oncology group (ecog) performance status of < or = to 2
boolean
C1520224 (UMLS CUI [1])
Laboratory test result Consistent with Study Protocol
Item
8. laboratory test results within ranges specified by the protocol.
boolean
C0587081 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Malignant Neoplasms Disease Free of Duration | 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 Superficial spreading melanoma Requirement Excision | Exception Prostate carcinoma Prostate specific antigen measurement
Item
9. disease free of prior malignancies for > or = to 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast or superficial melanoma only requiring excision or prostate cancer with a prostate specific antigen (psa) that has not increased for at least 3 months.
boolean
C0006826 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0332296 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
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])
C0334438 (UMLS CUI [6,2])
C1514873 (UMLS CUI [6,3])
C0728940 (UMLS CUI [6,4])
C1705847 (UMLS CUI [7,1])
C0600139 (UMLS CUI [7,2])
C0201544 (UMLS CUI [7,3])
Study Subject All | Registration Risk Reduction Program
Item
10. all study participants must be willing to be registered into the mandatory revassist®
boolean
C0681850 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C1514821 (UMLS CUI [2,1])
C1137094 (UMLS CUI [2,2])
C3484370 (UMLS CUI [2,3])
Compliance behavior Risk Reduction Program
Item
program, and comply with the requirements of revassist®.
boolean
C1321605 (UMLS CUI [1,1])
C1137094 (UMLS CUI [1,2])
C3484370 (UMLS CUI [1,3])
Childbearing Potential Pregnancy Tests | Gender Contraceptive methods
Item
11. females of childbearing potential (fcbp) must comply with pregnancy testing requirements. men and women must use approved birth control methods during the study.
boolean
C3831118 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods
Item
12. women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with azacitidine.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
High risk of Thrombosis | Steroid therapy | Deep Vein Thrombosis | Anticoagulation Prophylactic treatment | Aspirin U/day | Warfarin | Heparin, Low-Molecular-Weight
Item
13. if at high risk for thrombotic event (such as on steroids or history of deep vein thrombosis), subjects must be able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid may use warfarin or low molecular weight heparin)
boolean
C0332167 (UMLS CUI [1,1])
C0040053 (UMLS CUI [1,2])
C0149783 (UMLS CUI [2])
C0149871 (UMLS CUI [3])
C0003281 (UMLS CUI [4,1])
C0199176 (UMLS CUI [4,2])
C0004057 (UMLS CUI [5,1])
C0456683 (UMLS CUI [5,2])
C0043031 (UMLS CUI [6])
C0019139 (UMLS CUI [7])
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. (lactating females must agree not to breast feed while taking lenalidomide).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Condition Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Condition Interferes with Interpretation Research data | Laboratory test result abnormal Interferes with Interpretation Research 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])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0438215 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (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])
Investigational New Drugs | Therapies, Investigational
Item
4. use of any other experimental drug or therapy within 28 days of baseline.
boolean
C0013230 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
Hypersensitivity Thalidomide | Mannitol allergy
Item
5. known hypersensitivity to thalidomide or mannitol.
boolean
C0020517 (UMLS CUI [1,1])
C0039736 (UMLS CUI [1,2])
C0571922 (UMLS CUI [2])
Erythema Nodosum | Rash desquamating | Intake 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])
C1512806 (UMLS CUI [3,1])
C0039736 (UMLS CUI [3,2])
C1512806 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C2348205 (UMLS CUI [4,3])
lenalidomide | Azacitidine
Item
7. any prior use of lenalidomide or azacitidine
boolean
C1144149 (UMLS CUI [1])
C0004475 (UMLS CUI [2])
Antineoplastic Agents Other | Cancer treatment Other
Item
8. concurrent use of other anti-cancer agents or treatments
boolean
C0003392 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0920425 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
Item
9. known positive for hiv or infectious hepatitis, type b or c
boolean
C0019699 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Chemotherapy | Biological Agents | Immunotherapy | Toxicity Therapy Related | Patient recovered | Toxicity CTCAE Grades
Item
10. no chemotherapy, biologics or immunotherapy within 2 weeks prior to registration as specified in the protocol. subjects must have recovered from all therapy-related non-hematological toxicities to < grade 1 or to baseline if patient started with > grade 1 toxicity. there is no time limit with regards to radiation prior to registration.
boolean
C0392920 (UMLS CUI [1])
C0005515 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0600688 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C0439849 (UMLS CUI [4,3])
C1115804 (UMLS CUI [5])
C0600688 (UMLS CUI [6,1])
C1516728 (UMLS CUI [6,2])
Radioimmunotherapy | Toxicity Therapy Related | Patient recovered | Toxicity CTCAE Grades
Item
11. no radioimmunotherapy within 2 months prior to registration. subjects must have recovered from all therapy-related toxicities to < grade 1 or to baseline if patient started with > grade 1 toxicity.
boolean
C0085101 (UMLS CUI [1])
C0600688 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C1115804 (UMLS CUI [3])
C0600688 (UMLS CUI [4,1])
C1516728 (UMLS CUI [4,2])
Allogeneic Stem Cell Transplantation | Exception Graft acceptance Allogeneic Percentage
Item
12. no prior allogeneic stem cell transplantation unless allogeneic engraftment is <2%
boolean
C2242529 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0301944 (UMLS CUI [2,2])
C1515895 (UMLS CUI [2,3])
C0439165 (UMLS CUI [2,4])
CORTICOSTEROIDS FOR SYSTEMIC USE chronic | Equivalent Prednisolone U/day
Item
13. subjects receiving chronic, systemic treatment with corticosteroids equivalent to >20mg of prednisone per day
boolean
C3653708 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0205163 (UMLS CUI [2,1])
C0032950 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])