ID

30387

Beschrijving

Lenalidomide Plus Rituximab for Indolent Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00695786

Link

https://clinicaltrials.gov/show/NCT00695786

Trefwoorden

Versies (1)
  1. 01-06-18 01-06-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

1 juni 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00695786

Engels

Eligibility Lymphoma NCT00695786

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00695786
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. understand and voluntarily sign an informed consent form.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
2. age >/= 18 at the time of signing the informed consent form.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
3. able to adhere to the study visit schedule and other protocol requirements.
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
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).
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1,1]
C1334170
UMLS CUI [1,2]
C0332155
UMLS CUI [1,3]
C0432516
UMLS CUI [2]
C0855095
UMLS CUI [3]
C1367654
UMLS CUI [4,1]
C0024301
UMLS CUI [4,2]
C0432516
UMLS CUI [5,1]
C0279134
UMLS CUI [5,2]
C0277565
5. at least one measurable lesion according to the international workshop standardized response criteria for non-hodgkin's lymphomas (iwg) greater than 1.5cm.
Beschrijving

Measurable lesion Size Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C1265611
6. ecog performance status of </= 2 at study entry.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
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.
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0201976
UMLS CUI [5]
C1278039
UMLS CUI [6]
C0201899
UMLS CUI [7]
C0201836
UMLS CUI [8]
C0494165
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.
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0332296
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0686288
UMLS CUI [5,3]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1273390
UMLS CUI [6,3]
C0600139
UMLS CUI [6,4]
C0392752
9. all study participants must be registered into the mandatory revassist® program, and be willing and able to comply with the requirements of revassist®.
Beschrijving

Enrollment Risk Reduction Program | Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C1137094
UMLS CUI [1,3]
C3484370
UMLS CUI [2]
C0525058
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.
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430057
UMLS CUI [3]
C1144149
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0036899
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0700589
UMLS CUI [5,3]
C1265611
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C0032976
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.
Beschrijving

Gender Latex condom Coitus Childbearing Potential | Vasectomy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3873750
UMLS CUI [1,3]
C0009253
UMLS CUI [1,4]
C3831118
UMLS CUI [2]
C0042387
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.
Beschrijving

Bulky Disease | Aspirin U/day | Anticoagulation Therapy Prophylactic | Aspirin intolerance | Warfarin | Heparin, Low-Molecular-Weight

Datatype

boolean

Alias
UMLS CUI [1]
C1511341
UMLS CUI [2,1]
C0004057
UMLS CUI [2,2]
C0456683
UMLS CUI [3,1]
C0003281
UMLS CUI [3,2]
C0199176
UMLS CUI [4]
C0004059
UMLS CUI [5]
C0043031
UMLS CUI [6]
C0019139
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Beschrijving

Medical condition Serious Preventing Informed Consent | Laboratory test result abnormal Preventing Informed Consent | Mental disorders Preventing Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C0021430
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0021430
2. pregnant or breast feeding females.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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.
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0459471
UMLS CUI [3,4]
C0681873
UMLS CUI [4,1]
C0438215
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0459471
UMLS CUI [4,4]
C0681873
4. use of any chemotherapy or experimental therapy within 28 days of enrollment.
Beschrijving

Chemotherapy | Therapies, Investigational

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0949266
5. known hypersensitivity to thalidomide.
Beschrijving

Hypersensitivity Thalidomide

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0039736
6. the development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Beschrijving

Erythema Nodosum | Rash desquamating | Use of Thalidomide | Intake Pharmaceutical Preparations Similar

Datatype

boolean

Alias
UMLS CUI [1]
C0014743
UMLS CUI [2]
C0542171
UMLS CUI [3,1]
C1524063
UMLS CUI [3,2]
C0039736
UMLS CUI [4,1]
C1512806
UMLS CUI [4,2]
C0013227
UMLS CUI [4,3]
C2348205
7. any prior use of lenalidomide.
Beschrijving

Prior use of Lenalidomide

Datatype

boolean

Alias
UMLS CUI [1,1]
C2114648
UMLS CUI [1,2]
C1144149
8. concurrent use of other anti-cancer agents or experimental treatments.
Beschrijving

Antineoplastic Agents | Therapies, Investigational

Datatype

boolean

Alias
UMLS CUI [1]
C0003392
UMLS CUI [2]
C0949266
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.)
Beschrijving

HIV Seropositivity | Hepatitis B positive | Hepatitis C positive

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0856706
UMLS CUI [3]
C1112419
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Similar models

Eligibility Lymphoma NCT00695786

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00695786
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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