ID

41082

Descrizione

Combination of Lenalidomide and Rituximab in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL-SLL); ODM derived from: https://clinicaltrials.gov/show/NCT01446133

collegamento

https://clinicaltrials.gov/show/NCT01446133

Keywords

versioni (1)
  1. 21/06/20 21/06/20 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

21 giugno 2020

DOI

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Licenza

Creative Commons BY 4.0
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Eligibility Leukemia NCT01446133

Inglese

Eligibility Leukemia NCT01446133

1 moduli  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01446133
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age >/-18 at the time of signing of informed consent.understand and voluntarily sign informed consent.
Descrizione

Age | Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
2. patients with chronic lymphocytic leukemia and untreated disease with indication for treatment that are not candidates or unwilling to receive chemoimmunotherapy, or patients of any age with previously treated cll/sll or recurrent disease. patients with recurrent disease are eligible if they have received prior treatment with purine analog based chemotherapy or chemoimmunotherapy or bendamustine.
Descrizione

Chronic Lymphocytic Leukemia | Disease Untreated | Indication Therapy | Chemoimmunotherapy Inappropriate | Chemoimmunotherapy Unwilling | Prior Therapy Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | Recurrent disease | Purine analog Chemotherapy | Chemoimmunotherapy | bendamustine

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332155
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0087111
UMLS CUI [4,1]
C2986423
UMLS CUI [4,2]
C1548788
UMLS CUI [5,1]
C2986423
UMLS CUI [5,2]
C0558080
UMLS CUI [6,1]
C1514463
UMLS CUI [6,2]
C1302547
UMLS CUI [7]
C0277556
UMLS CUI [8,1]
C1268902
UMLS CUI [8,2]
C0392920
UMLS CUI [9]
C2986423
UMLS CUI [10]
C0525079
3. ecog/who performance status of 0-2.
Descrizione

ECOG performance status | WHO performance status scale

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C1298650
4. adequate renal function indicated by serum creatinine less or equal to 2mg/dl
Descrizione

Renal function | Creatinine measurement, serum

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
5. adequate hepatic function indicated as total bilirubin less or equal to 2mg/dl and alt less or equal to 2 times the upper limit of normal.
Descrizione

Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
6. disease free of prior malignancies for 3 years with exception of current 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 or surgery can be enrolled in this study as long as they have a reasonable expectation to have been cured with the treatment modality received.
Descrizione

Disease Free of Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of female breast | Therapeutic radiology procedure Prostate carcinoma | Operative Surgical Procedure Prostate carcinoma | Prostate carcinoma Cured

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332296
UMLS CUI [1,3]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0686288
UMLS CUI [6,1]
C1522449
UMLS CUI [6,2]
C0600139
UMLS CUI [7,1]
C0543467
UMLS CUI [7,2]
C0600139
UMLS CUI [8,1]
C0600139
UMLS CUI [8,2]
C1880198
7. all study participants must be registered into the mandatory revassist program and be willing and able to comply with the program requirements.
Descrizione

Protocol Compliance

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0525058
8. females of childbearing potential (fcbp) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mlu/ml within 10-14 days and again within 24 hours prior to prescribing lenalidomide for cycle 1. prescriptions must be filled within 7 days and must either commit to continued abstinence from heterosexual intercourse or use two acceptable methods of birth control, one highly effective method and one additional effective method at the same time at least 28 days before she starts taking lenalidomide. fcbp must also agree to ongoing pregnancy testing. men must agree to use a latex condom during sexual contact with a fcbp even if they have had a successful vasectomy.
Descrizione

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | lenalidomide | Sexual Abstinence Coitus | Contraceptive methods Quantity | Pregnancy Tests | Gender Latex condom | Vasectomy

Tipo di dati

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 [5,1]
C0700589
UMLS CUI [5,2]
C1265611
UMLS CUI [6]
C0032976
UMLS CUI [7,1]
C0079399
UMLS CUI [7,2]
C3873750
UMLS CUI [8]
C0042387
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. known sensitivity to lenalidomide or other thalidomide derivatives or rituximab.
Descrizione

Hypersensitivity Lenalidomide | Hypersensitivity Thalidomide Derivative | Hypersensitivity Rituximab

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1144149
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0039736
UMLS CUI [2,3]
C1527240
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0393022
2. documented prolymphocytic leukemia (prolymphocytes more than 55% in the peripheral blood).
Descrizione

Prolymphocytic Leukemia

Tipo di dati

boolean

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

HIV Seropositivity | Hepatitis B | Hepatitis C

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
4. pregnant or breast feeding females.
Descrizione

Pregnancy | Breast Feeding

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
5. history of tuberculosis treated within the last five years or recent exposure to tuberculosis.
Descrizione

History of tuberculosis Treated | Exposure to Tuberculosis

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0455460
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0041296
6. any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject at unacceptable risk if he/she were to participate in the study.
Descrizione

Medical condition Serious Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Mental disorder Study Subject Participation Status At risk

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
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
7. patients with a recent history of deep vein thrombosis (dvt) or pulmonary embolus (pe) in the six months prior to enrollment are not eligible for the study.
Descrizione

Deep Vein Thrombosis | Pulmonary Embolism

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0149871
UMLS CUI [2]
C0034065
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Similar models

Eligibility Leukemia NCT01446133

1 moduli
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01446133
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Age | Informed Consent
Item
1. age >/-18 at the time of signing of informed consent.understand and voluntarily sign informed consent.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Chronic Lymphocytic Leukemia | Disease Untreated | Indication Therapy | Chemoimmunotherapy Inappropriate | Chemoimmunotherapy Unwilling | Prior Therapy Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | Recurrent disease | Purine analog Chemotherapy | Chemoimmunotherapy | bendamustine
Item
2. patients with chronic lymphocytic leukemia and untreated disease with indication for treatment that are not candidates or unwilling to receive chemoimmunotherapy, or patients of any age with previously treated cll/sll or recurrent disease. patients with recurrent disease are eligible if they have received prior treatment with purine analog based chemotherapy or chemoimmunotherapy or bendamustine.
boolean
C0023434 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C3146298 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C2986423 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
C2986423 (UMLS CUI [5,1])
C0558080 (UMLS CUI [5,2])
C1514463 (UMLS CUI [6,1])
C1302547 (UMLS CUI [6,2])
C0277556 (UMLS CUI [7])
C1268902 (UMLS CUI [8,1])
C0392920 (UMLS CUI [8,2])
C2986423 (UMLS CUI [9])
C0525079 (UMLS CUI [10])
ECOG performance status | WHO performance status scale
Item
3. ecog/who performance status of 0-2.
boolean
C1520224 (UMLS CUI [1])
C1298650 (UMLS CUI [2])
Renal function | Creatinine measurement, serum
Item
4. adequate renal function indicated by serum creatinine less or equal to 2mg/dl
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement
Item
5. adequate hepatic function indicated as total bilirubin less or equal to 2mg/dl and alt less or equal to 2 times the upper limit of normal.
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Disease Free of Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of female breast | Therapeutic radiology procedure Prostate carcinoma | Operative Surgical Procedure Prostate carcinoma | Prostate carcinoma Cured
Item
6. disease free of prior malignancies for 3 years with exception of current 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 or surgery can be enrolled in this study as long as they have a reasonable expectation to have been cured with the treatment modality received.
boolean
C0012634 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0686288 (UMLS CUI [5,2])
C1522449 (UMLS CUI [6,1])
C0600139 (UMLS CUI [6,2])
C0543467 (UMLS CUI [7,1])
C0600139 (UMLS CUI [7,2])
C0600139 (UMLS CUI [8,1])
C1880198 (UMLS CUI [8,2])
Protocol Compliance
Item
7. all study participants must be registered into the mandatory revassist program and be willing and able to comply with the program requirements.
boolean
C0525058 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | lenalidomide | Sexual Abstinence Coitus | Contraceptive methods Quantity | Pregnancy Tests | Gender Latex condom | Vasectomy
Item
8. females of childbearing potential (fcbp) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mlu/ml within 10-14 days and again within 24 hours prior to prescribing lenalidomide for cycle 1. prescriptions must be filled within 7 days and must either commit to continued abstinence from heterosexual intercourse or use two acceptable methods of birth control, one highly effective method and one additional effective method at the same time at least 28 days before she starts taking lenalidomide. fcbp must also agree to ongoing pregnancy testing. men must agree to use a latex condom during sexual contact with a fcbp even if they have had a successful vasectomy.
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])
C0700589 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0032976 (UMLS CUI [6])
C0079399 (UMLS CUI [7,1])
C3873750 (UMLS CUI [7,2])
C0042387 (UMLS CUI [8])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Lenalidomide | Hypersensitivity Thalidomide Derivative | Hypersensitivity Rituximab
Item
1. known sensitivity to lenalidomide or other thalidomide derivatives or rituximab.
boolean
C0020517 (UMLS CUI [1,1])
C1144149 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0039736 (UMLS CUI [2,2])
C1527240 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0393022 (UMLS CUI [3,2])
Prolymphocytic Leukemia
Item
2. documented prolymphocytic leukemia (prolymphocytes more than 55% in the peripheral blood).
boolean
C0023486 (UMLS CUI [1])
HIV Seropositivity | Hepatitis B | Hepatitis C
Item
3. 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
4. pregnant or breast feeding females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
History of tuberculosis Treated | Exposure to Tuberculosis
Item
5. history of tuberculosis treated within the last five years or recent exposure to tuberculosis.
boolean
C0455460 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0041296 (UMLS CUI [2,2])
Medical condition Serious Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Mental disorder Study Subject Participation Status At risk
Item
6. any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject at unacceptable risk if he/she were to participate in the study.
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1444641 (UMLS CUI [1,4])
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])
Deep Vein Thrombosis | Pulmonary Embolism
Item
7. patients with a recent history of deep vein thrombosis (dvt) or pulmonary embolus (pe) in the six months prior to enrollment are not eligible for the study.
boolean
C0149871 (UMLS CUI [1])
C0034065 (UMLS CUI [2])
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