ID

20602

Beskrivning

Lenalidomide as Initial Treatment of Patients With Chronic Lymphocytic Leukemia (CLL) Age 65 and Older; ODM derived from: https://clinicaltrials.gov/show/NCT00535873

Länk

https://clinicaltrials.gov/show/NCT00535873

Nyckelord

Versioner (1)
  1. 2017-03-06 2017-03-06 -
Uppladdad den

6 mars 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Leukemia NCT00535873

Engelsk

Eligibility Leukemia NCT00535873

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00535873
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with untreated cll or small lymphocytic lymphoma (sll) with indication to treatment according to nci working group guidelines.patients that have received single agent rituximab will be allowed to participate in this study.
Beskrivning

Chronic Lymphocytic Leukemia; Did not receive therapy or drug for | Small Lymphocytic Lymphoma; Did not receive therapy or drug for | rituximab | Planned Treatment Regimen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0855095
UMLS CUI [2,2]
C0332155
UMLS CUI [3]
C0393022
UMLS CUI [4]
C3641097
2. age 65 or older
Beskrivning

age

Datatyp

boolean

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

ecog, who performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C1298650
4. adequate renal function indicated by serum creatinine less or equal to 2 and adequate hepatic function indicated as total bilirubin less or equal to upper level of normal and as alanine aminotransferase (alt) less or equal 2 upper limit of normal (uln).
Beskrivning

Creatinine measurement, serum (procedure) | Bilirubin, total measurement | Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0201913
UMLS CUI [3]
C0201836
5. able to understand and sign informed consent after the investigational nature, study design, risks and benefits have been explained.
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
6. able to adhere to the study visit schedule and other protocol requirements.
Beskrivning

protocol compliance, compliance behaviour

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C1321605
7. 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

Personal history of malignant neoplasm, unspecified | Basal cell carcinoma | Squamous cell carcinoma of skin | Carcinoma in situ of uterine cervix | Stage 0 Breast Carcinoma | Prostate carcinoma; prior radiation therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0260455
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0553723
UMLS CUI [4]
C0851140
UMLS CUI [5]
C0154084
UMLS CUI [6,1]
C0600139
UMLS CUI [6,2]
C0279134
UMLS CUI [6,3]
C0679252
8. 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; 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). 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

Female of child bearing age | Female Sterilization | Postmenopausal state | Pregnancy | Sexual Abstinence | Contraceptive methods | lenalidomide

Datatyp

boolean

Alias
UMLS CUI [1]
C1960468
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0032961
UMLS CUI [5]
C0036899
UMLS CUI [6]
C0700589
UMLS CUI [7]
C1144149
9. 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.
Beskrivning

Condoms, Male; Coitus; Female of child bearing age | Vasectomy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009653
UMLS CUI [1,2]
C0009253
UMLS CUI [1,3]
C1960468
UMLS CUI [2]
C0042387
10. all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
Beskrivning

Counsel patient about contraceptive use

Datatyp

boolean

Alias
UMLS CUI [1]
C0509751
11. all patients must be able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid (asa) may use warfarin or low molecular weight heparin.
Beskrivning

Aspirin | Anticoagulation Therapy | Warfarin | Heparin, Low-Molecular-Weight

Datatyp

boolean

Alias
UMLS CUI [1]
C0003281
UMLS CUI [2]
C0004057
UMLS CUI [3]
C0043031
UMLS CUI [4]
C0019139
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

hypersensitivity thalidomide

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0039736
2. documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).
Beskrivning

prolymphocytic leukemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0023486
3. known positivity for hiv or active hepatitis (b or c).
Beskrivning

known positivity for hiv or active hepatitis (b or c)

Datatyp

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2,1]
C0205177
UMLS CUI [2,2]
C0019163
UMLS CUI [3,1]
C0205177
UMLS CUI [3,2]
C0019196
4. a serious medical condition, laboratory abnormality or psychiatric illness that would interfere with the ability of the patient to participate in this program according to the judgement of the principal investigator.
Beskrivning

Comorbidity | Laboratory test result abnormal | Mental disorders | Limited (extensiveness); Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0438215
UMLS CUI [3]
C0004936
UMLS CUI [4,1]
C0439801
UMLS CUI [4,2]
C0525058
5. active cardiovascular disease as defined by the new york heart association class 3 or 4.
Beskrivning

cardiovascular disease, nyha

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C1275491
6. history of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Beskrivning

erythema nodosum

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0014743
UMLS CUI [1,2]
C0542171
UMLS CUI [1,3]
C0039736
7. concurrent use of other chemotherapy agents.
Beskrivning

Antineoplastic Agents; Concurrent use of pharmaceutical agents

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C4060806
8. 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
9. no known history of tuberculosis or recent exposure to tuberculosis.
Beskrivning

no known history of tuberculosis or recent exposure to tuberculosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0375796
UMLS CUI [2]
C0149796
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Similar models

Eligibility Leukemia NCT00535873

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00535873
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia; Did not receive therapy or drug for | Small Lymphocytic Lymphoma; Did not receive therapy or drug for | rituximab | Planned Treatment Regimen
Item
1. patients with untreated cll or small lymphocytic lymphoma (sll) with indication to treatment according to nci working group guidelines.patients that have received single agent rituximab will be allowed to participate in this study.
boolean
C0023434 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0855095 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0393022 (UMLS CUI [3])
C3641097 (UMLS CUI [4])
age
Item
2. age 65 or older
boolean
C0001779 (UMLS CUI [1])
ecog, who performance status
Item
3. eastern cooperative oncology group (ecog)/world health organization (who) performance status of 0-2.
boolean
C1520224 (UMLS CUI [1])
C1298650 (UMLS CUI [2])
Creatinine measurement, serum (procedure) | Bilirubin, total measurement | Alanine aminotransferase measurement
Item
4. adequate renal function indicated by serum creatinine less or equal to 2 and adequate hepatic function indicated as total bilirubin less or equal to upper level of normal and as alanine aminotransferase (alt) less or equal 2 upper limit of normal (uln).
boolean
C0201976 (UMLS CUI [1])
C0201913 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
informed consent
Item
5. able to understand and sign informed consent after the investigational nature, study design, risks and benefits have been explained.
boolean
C0021430 (UMLS CUI [1])
protocol compliance, compliance behaviour
Item
6. able to adhere to the study visit schedule and other protocol requirements.
boolean
C0525058 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
Personal history of malignant neoplasm, unspecified | Basal cell carcinoma | Squamous cell carcinoma of skin | Carcinoma in situ of uterine cervix | Stage 0 Breast Carcinoma | Prostate carcinoma; prior radiation therapy
Item
7. 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
C0260455 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
C0851140 (UMLS CUI [4])
C0154084 (UMLS CUI [5])
C0600139 (UMLS CUI [6,1])
C0279134 (UMLS CUI [6,2])
C0679252 (UMLS CUI [6,3])
Female of child bearing age | Female Sterilization | Postmenopausal state | Pregnancy | Sexual Abstinence | Contraceptive methods | lenalidomide
Item
8. 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; 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). 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
C1960468 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0032961 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
C0700589 (UMLS CUI [6])
C1144149 (UMLS CUI [7])
Condoms, Male; Coitus; Female of child bearing age | Vasectomy
Item
9. 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.
boolean
C0009653 (UMLS CUI [1,1])
C0009253 (UMLS CUI [1,2])
C1960468 (UMLS CUI [1,3])
C0042387 (UMLS CUI [2])
Counsel patient about contraceptive use
Item
10. all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
boolean
C0509751 (UMLS CUI [1])
Aspirin | Anticoagulation Therapy | Warfarin | Heparin, Low-Molecular-Weight
Item
11. all patients must be able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid (asa) may use warfarin or low molecular weight heparin.
boolean
C0003281 (UMLS CUI [1])
C0004057 (UMLS CUI [2])
C0043031 (UMLS CUI [3])
C0019139 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
hypersensitivity thalidomide
Item
1. known sensitivity to thalidomide or its derivatives.
boolean
C0020517 (UMLS CUI [1,1])
C0039736 (UMLS CUI [1,2])
prolymphocytic leukemia
Item
2. documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).
boolean
C0023486 (UMLS CUI [1])
known positivity for hiv or active hepatitis (b or c)
Item
3. known positivity for hiv or active hepatitis (b or c).
boolean
C0019682 (UMLS CUI [1])
C0205177 (UMLS CUI [2,1])
C0019163 (UMLS CUI [2,2])
C0205177 (UMLS CUI [3,1])
C0019196 (UMLS CUI [3,2])
Comorbidity | Laboratory test result abnormal | Mental disorders | Limited (extensiveness); Protocol Compliance
Item
4. a serious medical condition, laboratory abnormality or psychiatric illness that would interfere with the ability of the patient to participate in this program according to the judgement of the principal investigator.
boolean
C0009488 (UMLS CUI [1])
C0438215 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
C0439801 (UMLS CUI [4,1])
C0525058 (UMLS CUI [4,2])
cardiovascular disease, nyha
Item
5. active cardiovascular disease as defined by the new york heart association class 3 or 4.
boolean
C0007222 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
erythema nodosum
Item
6. history of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
boolean
C0014743 (UMLS CUI [1,1])
C0542171 (UMLS CUI [1,2])
C0039736 (UMLS CUI [1,3])
Antineoplastic Agents; Concurrent use of pharmaceutical agents
Item
7. concurrent use of other chemotherapy agents.
boolean
C0003392 (UMLS CUI [1,1])
C4060806 (UMLS CUI [1,2])
pregnancy, breast feeding
Item
8. 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])
no known history of tuberculosis or recent exposure to tuberculosis
Item
9. no known history of tuberculosis or recent exposure to tuberculosis.
boolean
C0375796 (UMLS CUI [1])
C0149796 (UMLS CUI [2])
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