ID

28060

Beskrivning

Lenalidomide in Chronic Lymphocytic Leukemia (CLL) Patients With Residual Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00632359

Länk

https://clinicaltrials.gov/show/NCT00632359

Nyckelord

Versioner (1)
  1. 2017-12-13 2017-12-13 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

13 december 2017

DOI

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Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia NCT00632359

Engelsk

Eligibility Chronic Lymphocytic Leukemia NCT00632359

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
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.
Beskrivning

Chemotherapy Completed | Lenalidomide

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C1144149
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.
Beskrivning

CLL/Small Lymphocytic Lymphoma | Complete remission | Partial response Stable | Combination Chemotherapy | Residual disease Immunophenotyping | Residual disease Polymerase Chain Reaction Molecular Testing

Datatyp

boolean

Alias
UMLS CUI [1]
C1302547
UMLS CUI [2]
C0677874
UMLS CUI [3,1]
C1521726
UMLS CUI [3,2]
C0205360
UMLS CUI [4]
C1521750
UMLS CUI [5,1]
C0543478
UMLS CUI [5,2]
C0079611
UMLS CUI [6,1]
C0543478
UMLS CUI [6,2]
C0032520
UMLS CUI [6,3]
C0752096
3. eastern cooperative oncology group (ecog)/world health organization (who) status of 0-2.
Beskrivning

ECOG performance status | WHO performance status scale

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C1298650
4. adequate renal and hepatic function (creatinine equal to or less than 2mg/dl - total bilirubin equal to or less than 2).
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0201976
UMLS CUI [4]
C1278039
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).
Beskrivning

Childbearing Potential | Hysterectomy Absent | Bilateral oophorectomy Absent | Postmenopausal state Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C0020699
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0278321
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0232970
UMLS CUI [4,2]
C0332197
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.
Beskrivning

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Abstinence Coitus | Childbearing Potential Contraceptive methods Quantity

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 [3,1]
C3831118
UMLS CUI [3,2]
C3843422
UMLS CUI [3,3]
C0009253
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C1265611
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.
Beskrivning

Childbearing Potential Pregnancy Tests Frequency

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032976
UMLS CUI [1,3]
C0439603
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.
Beskrivning

Gender | Latex condom | Vasectomy | Counseling Contraceptive methods | Counseling Risk Fetal exposure

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C3873750
UMLS CUI [3]
C0042387
UMLS CUI [4,1]
C0010210
UMLS CUI [4,2]
C0700589
UMLS CUI [5,1]
C0010210
UMLS CUI [5,2]
C0035647
UMLS CUI [5,3]
C0871747
9. age 18 and older.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
10. signed, written irb-approved informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. known sensitivity to lenalidomide or thalidomide or it's derivatives
Beskrivning

Hypersensitivity Lenalidomide | Hypersensitivity Thalidomide | Hypersensitivity Lenalidomide Derivative | Hypersensitivity Thalidomide Derivative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1144149
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0039736
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1144149
UMLS CUI [3,3]
C1527240
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0039736
UMLS CUI [4,3]
C1527240
2. known positivity for hiv or active hepatitis b or c.
Beskrivning

HIV Seropositivity | Hepatitis B | Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
3. pregnant or breast feeding females. lactating females must agree not to breast feed while taking lenalidomide.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
4. history of tuberculosis within the last five years or recent exposure to tuberculosis equal to or less than 6 months.
Beskrivning

Tuberculosis | Exposure to Tuberculosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0041296
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0041296
5. any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Beskrivning

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

Datatyp

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
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.
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [1,4]
C1883420
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1444641
UMLS CUI [2,4]
C1883420
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
7. use of any other experimental drug or therapy within 28 days of baseline.
Beskrivning

Investigational New Drugs | Therapies, Investigational

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0949266
8. concurrent use of other anti-cancer agents or treatments
Beskrivning

Antineoplastic Agents | Cancer treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0003392
UMLS CUI [2]
C0920425
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Similar models

Eligibility Chronic Lymphocytic Leukemia NCT00632359

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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