ID

20112

Beskrivning

Lenalidomide (Revlimid) in Chronic Lymphocytic Leukemia (CLL); ODM derived from: https://clinicaltrials.gov/show/NCT00267059

Länk

https://clinicaltrials.gov/show/NCT00267059

Nyckelord

Versioner (1)
  1. 2017-02-07 2017-02-07 -
Uppladdad den

7 februari 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia NCT00267059

Engelsk

Eligibility Chronic Lymphocytic Leukemia NCT00267059

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with b-cell cll with indications for treatment by national cancer institute (nci) working group criteria, or rai stage iii or iv or patients with cll requiring treatment because of any of the following: disease related symptoms, progressive marrow failure (development or worsening of anemia and/or patients' thrombocytopenia) progressive splenomegaly, progressive lymphoadenopathy, progressive lymphocytosis
Beskrivning

Chronic Lymphocytic Leukemia Requirement Therapeutic procedure | Chronic Lymphocytic Leukemia Rai Staging System | Symptoms Disease Related | Pancytopenia Progressive | Anemia Worsening | Thrombocytopenia | Splenomegaly Progressive | Lymphadenopathy Progressive | Lymphocytosis Progressive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0023434
UMLS CUI [2,2]
C1514715
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0439849
UMLS CUI [4,1]
C0030312
UMLS CUI [4,2]
C0205329
UMLS CUI [5,1]
C0002871
UMLS CUI [5,2]
C0332271
UMLS CUI [6]
C0040034
UMLS CUI [7,1]
C0038002
UMLS CUI [7,2]
C0205329
UMLS CUI [8,1]
C0497156
UMLS CUI [8,2]
C0205329
UMLS CUI [9,1]
C0024282
UMLS CUI [9,2]
C0205329
2. patients who have received a minimum of one prior purine analog-based chemotherapy regimen. prior treatment with corticosteroids, immunotherapy, monoclonal antibody or radiation therapy is permitted. all previous cancer therapy, including radiation, hormonal therapy and surgery must have been discontinued 2 weeks prior to treatment in this study. any cytotoxic chemotherapy must be discontinued 4 weeks prior to treatment in this study.
Beskrivning

Chemotherapy Regimen Purine analog Based | Adrenal Cortex Hormones | Immunotherapy | Monoclonal Antibody Therapy | Therapeutic radiology procedure | cancer treatment Discontinued | cancer radiation therapy Discontinued | Hormone Therapy Discontinued | Operative Surgical Procedures Discontinued | Cytotoxic Chemotherapy To be stopped

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1268902
UMLS CUI [1,3]
C1705938
UMLS CUI [2]
C0001617
UMLS CUI [3]
C0021083
UMLS CUI [4]
C0279694
UMLS CUI [5]
C1522449
UMLS CUI [6,1]
C0920425
UMLS CUI [6,2]
C1444662
UMLS CUI [7,1]
C0920418
UMLS CUI [7,2]
C1444662
UMLS CUI [8,1]
C0279025
UMLS CUI [8,2]
C1444662
UMLS CUI [9,1]
C0543467
UMLS CUI [9,2]
C1444662
UMLS CUI [10,1]
C0677881
UMLS CUI [10,2]
C1272691
3. age more or equal to 18 years (cll is not observed in patients less than 18 years of age).
Beskrivning

Age | Chronic Lymphocytic Leukemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0023434
4. eastern cooperative oncology group (ecog)/world health organization (who) performance status 0-2.
Beskrivning

ECOG performance status | WHO performance status scale

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C1298650
5. adequate renal function indicated by serum creatinine less or equal to 2 and adequate hepatic function indicated as total bilirubin less or equal to 2 times the upper limit of normal.
Beskrivning

Renal function | Creatinine measurement, serum | Liver function | Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0232741
UMLS CUI [4]
C1278039
6. understand and sign informed consent after the investigational nature, study design, risks and benefits of the study have been explained.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
7. 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 starting 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.
Beskrivning

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | lenalidomide | Abstinence Coitus Heterosexual | Contraceptive methods Quantity | Childbearing Potential Pregnancy Tests Continuous

Datatyp

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]
C0036899
UMLS CUI [4,2]
C0009253
UMLS CUI [4,3]
C0019421
UMLS CUI [5,1]
C0700589
UMLS CUI [5,2]
C1265611
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C0032976
UMLS CUI [6,3]
C0549178
8. continued from #7. men must agree to use a condom during sexual contact with a female of child bearing potential 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.
Beskrivning

Gender Male Condoms | Vasectomy | Pregnancy Precaution

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0009653
UMLS CUI [2]
C0042387
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1882442
9. continued from #8. a female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
Beskrivning

Gender Childbearing Potential | Hysterectomy | Bilateral oophorectomy | Postmenopausal state | Menstruation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3831118
UMLS CUI [2]
C0020699
UMLS CUI [3]
C0278321
UMLS CUI [4]
C0232970
UMLS CUI [5]
C0025344
10. disease free of prior malignancies for 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. patients with malignancies with indolent behavior such as prostate cancer treated with radiation can be enrolled in the study as long as they have a reasonable expectation to have been cured with treatment modality received.
Beskrivning

Malignant Neoplasms Disease Free of | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Carcinoma in situ of uterine cervix Treated | Carcinoma in situ of female breast Treated | Therapeutic radiology procedure Prostate carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0332296
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C0553723
UMLS CUI [3,2]
C1522326
UMLS CUI [4,1]
C0851140
UMLS CUI [4,2]
C1522326
UMLS CUI [5,1]
C0686288
UMLS CUI [5,2]
C1522326
UMLS CUI [6,1]
C1522449
UMLS CUI [6,2]
C0600139
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. known sensitivity to thalidomide or its derivatives
Beskrivning

Hypersensitivity Thalidomide | Hypersensitivity Thalidomide Derivative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0039736
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0039736
UMLS CUI [2,3]
C1527240
2. the development of erythema nodosum as characterized by a desquamating rash while taking thalidomide or similar drugs.
Beskrivning

Erythema Nodosum | Rash desquamating while Intake Thalidomide

Datatyp

boolean

Alias
UMLS CUI [1]
C0014743
UMLS CUI [2,1]
C0542171
UMLS CUI [2,2]
C0750519
UMLS CUI [2,3]
C1512806
UMLS CUI [2,4]
C0039736
3. prior use of lenalidomide
Beskrivning

lenalidomide

Datatyp

boolean

Alias
UMLS CUI [1]
C1144149
4. concurrent use of other chemotherapy agents.
Beskrivning

Antineoplastic Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0003392
5. known positivity for human immunodeficiency virus (hiv) or infectious hepatitis type a, b or c.
Beskrivning

HIV Seropositivity | Hepatitis A | HEPATITIS B INFECTIOUS | Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0019159
UMLS CUI [3]
C0744836
UMLS CUI [4]
C0019196
6. pregnant or lactating females.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
7. a serious medical condition, laboratory abnormality or psychiatric illness that would pose the subject at unacceptable risk if he/she were to participate in the study or that would interfere with the ability of the patient to carry out the treatment program or confine the ability to interpret the data from the study.
Beskrivning

Medical condition Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Mental disorder Study Subject Participation Status At risk | Medical condition Protocol Compliance Limited | Laboratory test result abnormal Protocol Compliance Limited | Mental disorder Protocol Compliance Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1444641
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C1444641
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0525058
UMLS CUI [4,3]
C0439801
UMLS CUI [5,1]
C0438215
UMLS CUI [5,2]
C0525058
UMLS CUI [5,3]
C0439801
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0525058
UMLS CUI [6,3]
C0439801
8. documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).
Beskrivning

Prolymphocytic Leukemia | Lymphocyte Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0023486
UMLS CUI [2]
C0200635
9. active cardiovascular disease as defined by the new york heart association class 3 or
Beskrivning

Cardiovascular Disease New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C1275491
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Similar models

Eligibility Chronic Lymphocytic Leukemia NCT00267059

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia Requirement Therapeutic procedure | Chronic Lymphocytic Leukemia Rai Staging System | Symptoms Disease Related | Pancytopenia Progressive | Anemia Worsening | Thrombocytopenia | Splenomegaly Progressive | Lymphadenopathy Progressive | Lymphocytosis Progressive
Item
1. patients with b-cell cll with indications for treatment by national cancer institute (nci) working group criteria, or rai stage iii or iv or patients with cll requiring treatment because of any of the following: disease related symptoms, progressive marrow failure (development or worsening of anemia and/or patients' thrombocytopenia) progressive splenomegaly, progressive lymphoadenopathy, progressive lymphocytosis
boolean
C0023434 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0023434 (UMLS CUI [2,1])
C1514715 (UMLS CUI [2,2])
C1457887 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0030312 (UMLS CUI [4,1])
C0205329 (UMLS CUI [4,2])
C0002871 (UMLS CUI [5,1])
C0332271 (UMLS CUI [5,2])
C0040034 (UMLS CUI [6])
C0038002 (UMLS CUI [7,1])
C0205329 (UMLS CUI [7,2])
C0497156 (UMLS CUI [8,1])
C0205329 (UMLS CUI [8,2])
C0024282 (UMLS CUI [9,1])
C0205329 (UMLS CUI [9,2])
Chemotherapy Regimen Purine analog Based | Adrenal Cortex Hormones | Immunotherapy | Monoclonal Antibody Therapy | Therapeutic radiology procedure | cancer treatment Discontinued | cancer radiation therapy Discontinued | Hormone Therapy Discontinued | Operative Surgical Procedures Discontinued | Cytotoxic Chemotherapy To be stopped
Item
2. patients who have received a minimum of one prior purine analog-based chemotherapy regimen. prior treatment with corticosteroids, immunotherapy, monoclonal antibody or radiation therapy is permitted. all previous cancer therapy, including radiation, hormonal therapy and surgery must have been discontinued 2 weeks prior to treatment in this study. any cytotoxic chemotherapy must be discontinued 4 weeks prior to treatment in this study.
boolean
C0392920 (UMLS CUI [1,1])
C1268902 (UMLS CUI [1,2])
C1705938 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0279694 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
C0920425 (UMLS CUI [6,1])
C1444662 (UMLS CUI [6,2])
C0920418 (UMLS CUI [7,1])
C1444662 (UMLS CUI [7,2])
C0279025 (UMLS CUI [8,1])
C1444662 (UMLS CUI [8,2])
C0543467 (UMLS CUI [9,1])
C1444662 (UMLS CUI [9,2])
C0677881 (UMLS CUI [10,1])
C1272691 (UMLS CUI [10,2])
Age | Chronic Lymphocytic Leukemia
Item
3. age more or equal to 18 years (cll is not observed in patients less than 18 years of age).
boolean
C0001779 (UMLS CUI [1])
C0023434 (UMLS CUI [2])
ECOG performance status | WHO performance status scale
Item
4. eastern cooperative oncology group (ecog)/world health organization (who) performance status 0-2.
boolean
C1520224 (UMLS CUI [1])
C1298650 (UMLS CUI [2])
Renal function | Creatinine measurement, serum | Liver function | Serum total bilirubin measurement
Item
5. adequate renal function indicated by serum creatinine less or equal to 2 and adequate hepatic function indicated as total bilirubin less or equal to 2 times the upper limit of normal.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
Informed Consent
Item
6. understand and sign informed consent after the investigational nature, study design, risks and benefits of the study have been explained.
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | lenalidomide | Abstinence Coitus Heterosexual | Contraceptive methods Quantity | Childbearing Potential Pregnancy Tests Continuous
Item
7. 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 starting 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])
C0036899 (UMLS CUI [4,1])
C0009253 (UMLS CUI [4,2])
C0019421 (UMLS CUI [4,3])
C0700589 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C3831118 (UMLS CUI [6,1])
C0032976 (UMLS CUI [6,2])
C0549178 (UMLS CUI [6,3])
Gender Male Condoms | Vasectomy | Pregnancy Precaution
Item
8. continued from #7. men must agree to use a condom during sexual contact with a female of child bearing potential 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 [1,1])
C0009653 (UMLS CUI [1,2])
C0042387 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1882442 (UMLS CUI [3,2])
Gender Childbearing Potential | Hysterectomy | Bilateral oophorectomy | Postmenopausal state | Menstruation
Item
9. continued from #8. a female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0020699 (UMLS CUI [2])
C0278321 (UMLS CUI [3])
C0232970 (UMLS CUI [4])
C0025344 (UMLS CUI [5])
Malignant Neoplasms Disease Free of | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Carcinoma in situ of uterine cervix Treated | Carcinoma in situ of female breast Treated | Therapeutic radiology procedure Prostate carcinoma
Item
10. disease free of prior malignancies for 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. patients with malignancies with indolent behavior such as prostate cancer treated with radiation can be enrolled in the study as long as they have a reasonable expectation to have been cured with treatment modality received.
boolean
C0006826 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0332296 (UMLS CUI [1,3])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0553723 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0851140 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0686288 (UMLS CUI [5,1])
C1522326 (UMLS CUI [5,2])
C1522449 (UMLS CUI [6,1])
C0600139 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Thalidomide | Hypersensitivity Thalidomide Derivative
Item
1. known sensitivity to thalidomide or its derivatives
boolean
C0020517 (UMLS CUI [1,1])
C0039736 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0039736 (UMLS CUI [2,2])
C1527240 (UMLS CUI [2,3])
Erythema Nodosum | Rash desquamating while Intake Thalidomide
Item
2. the development of erythema nodosum as characterized by a desquamating rash while taking thalidomide or similar drugs.
boolean
C0014743 (UMLS CUI [1])
C0542171 (UMLS CUI [2,1])
C0750519 (UMLS CUI [2,2])
C1512806 (UMLS CUI [2,3])
C0039736 (UMLS CUI [2,4])
lenalidomide
Item
3. prior use of lenalidomide
boolean
C1144149 (UMLS CUI [1])
Antineoplastic Agents
Item
4. concurrent use of other chemotherapy agents.
boolean
C0003392 (UMLS CUI [1])
HIV Seropositivity | Hepatitis A | HEPATITIS B INFECTIOUS | Hepatitis C
Item
5. known positivity for human immunodeficiency virus (hiv) or infectious hepatitis type a, b or c.
boolean
C0019699 (UMLS CUI [1])
C0019159 (UMLS CUI [2])
C0744836 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
6. pregnant or lactating females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical condition Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Mental disorder Study Subject Participation Status At risk | Medical condition Protocol Compliance Limited | Laboratory test result abnormal Protocol Compliance Limited | Mental disorder Protocol Compliance Limited
Item
7. a serious medical condition, laboratory abnormality or psychiatric illness that would pose the subject at unacceptable risk if he/she were to participate in the study or that would interfere with the ability of the patient to carry out the treatment program or confine the ability to interpret the data from the study.
boolean
C3843040 (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])
C0004936 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C1444641 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0525058 (UMLS CUI [4,2])
C0439801 (UMLS CUI [4,3])
C0438215 (UMLS CUI [5,1])
C0525058 (UMLS CUI [5,2])
C0439801 (UMLS CUI [5,3])
C0004936 (UMLS CUI [6,1])
C0525058 (UMLS CUI [6,2])
C0439801 (UMLS CUI [6,3])
Prolymphocytic Leukemia | Lymphocyte Count measurement
Item
8. documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).
boolean
C0023486 (UMLS CUI [1])
C0200635 (UMLS CUI [2])
Cardiovascular Disease New York Heart Association Classification
Item
9. active cardiovascular disease as defined by the new york heart association class 3 or
boolean
C0007222 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
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