Chemotherapy Completed | Lenalidomide
Item
1. patients should have completed their chemotherapy 3 months prior to start of treatment with lenalidomide and not more than 9 months prior to treatment initiation.
boolean
C0392920 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1144149 (UMLS CUI [2])
CLL/Small Lymphocytic Lymphoma | Complete remission | Partial response Stable | Combination Chemotherapy | Residual disease Immunophenotyping | Residual disease Polymerase Chain Reaction Molecular Testing
Item
2. patients with cll/small lymphocytic lymphoma (sll) that achieve a complete or stable partial remission after combination of chemotherapy. patients in complete remission need to have documentation of residual disease by immunophenotyping and/or pcr molecular testing.
boolean
C1302547 (UMLS CUI [1])
C0677874 (UMLS CUI [2])
C1521726 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C1521750 (UMLS CUI [4])
C0543478 (UMLS CUI [5,1])
C0079611 (UMLS CUI [5,2])
C0543478 (UMLS CUI [6,1])
C0032520 (UMLS CUI [6,2])
C0752096 (UMLS CUI [6,3])
ECOG performance status | WHO performance status scale
Item
3. eastern cooperative oncology group (ecog)/world health organization (who) status of 0-2.
boolean
C1520224 (UMLS CUI [1])
C1298650 (UMLS CUI [2])
Renal function | Liver function | Creatinine measurement, serum | Serum total bilirubin measurement
Item
4. adequate renal and hepatic function (creatinine equal to or less than 2mg/dl - total bilirubin equal to or less than 2).
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
Childbearing Potential | Hysterectomy Absent | Bilateral oophorectomy Absent | Postmenopausal state Absent
Item
5. females of childbearing potential (fcbp). a female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; 2) or has not been naturally postmenopausal for at least 24 consecutive months (has not had menses at any time in the preceding 24 consecutive months).
boolean
C3831118 (UMLS CUI [1])
C0020699 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0278321 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0232970 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Abstinence Coitus | Childbearing Potential Contraceptive methods Quantity
Item
6. 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 starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control; one highly effective and one additional effective method at the same time at least 28 days before starting taking lenalidomide.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C3843422 (UMLS CUI [3,2])
C0009253 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Childbearing Potential Pregnancy Tests Frequency
Item
7. fcbp must also agree to ongoing pregnancy testing weekly for the first four weeks and then every 28 days while on therapy and at discontinuation of treatment.
boolean
C3831118 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
Gender | Latex condom | Vasectomy | Counseling Contraceptive methods | Counseling Risk Fetal exposure
Item
8. men must agree to use a latex condom during sexual contact with a fcbp even if they have had a successful vasectomy. all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
boolean
C0079399 (UMLS CUI [1])
C3873750 (UMLS CUI [2])
C0042387 (UMLS CUI [3])
C0010210 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0010210 (UMLS CUI [5,1])
C0035647 (UMLS CUI [5,2])
C0871747 (UMLS CUI [5,3])
Age
Item
9. age 18 and older.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
10. signed, written irb-approved informed consent.
boolean
C0021430 (UMLS CUI [1])
Hypersensitivity Lenalidomide | Hypersensitivity Thalidomide | Hypersensitivity Lenalidomide Derivative | Hypersensitivity Thalidomide Derivative
Item
1. known sensitivity to lenalidomide or thalidomide or it's derivatives
boolean
C0020517 (UMLS CUI [1,1])
C1144149 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0039736 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1144149 (UMLS CUI [3,2])
C1527240 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0039736 (UMLS CUI [4,2])
C1527240 (UMLS CUI [4,3])
HIV Seropositivity | Hepatitis B | Hepatitis C
Item
2. known positivity for hiv or active hepatitis b or c.
boolean
C0019699 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
3. 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])
Tuberculosis | Exposure to Tuberculosis
Item
4. history of tuberculosis within the last five years or recent exposure to tuberculosis equal to or less than 6 months.
boolean
C0041296 (UMLS CUI [1])
C0332157 (UMLS CUI [2,1])
C0041296 (UMLS CUI [2,2])
Medical condition Serious Preventing Informed Consent | Laboratory test result abnormal Preventing Informed Consent | Mental disorders Preventing Informed Consent
Item
5. 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])
Condition Study Subject Participation Status At risk Unacceptable | Laboratory test result abnormal Study Subject Participation Status At risk Unacceptable | Condition Interferes with Interpretation Research data | Laboratory test result abnormal Interferes with Interpretation Research data
Item
6. 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])
C1883420 (UMLS CUI [1,4])
C0438215 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C1883420 (UMLS CUI [2,4])
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
7. use of any other experimental drug or therapy within 28 days of baseline.
boolean
C0013230 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
Antineoplastic Agents | Cancer treatment
Item
8. concurrent use of other anti-cancer agents or treatments
boolean
C0003392 (UMLS CUI [1])
C0920425 (UMLS CUI [2])