ID

12101

Beskrivning

Combination of Lenalidomide and Obinutuzumab (GA101) in Patients With Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL); ODM derived from: https://clinicaltrials.gov/show/NCT02225275

Länk

https://clinicaltrials.gov/show/NCT02225275

Nyckelord

Versioner (2)
  1. 2015-09-23 2015-09-23 - Julian Varghese
  2. 2015-09-23 2015-09-23 - Julian Varghese
Uppladdad den

23 september 2015

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy
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Eligibility Leukemia NCT02225275

Engelsk

Eligibility Leukemia NCT02225275

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02225275
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age 18 years or older at the time of signing informed consent. able to understand and to provide voluntarily informed consent;
Beskrivning

Age | Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
2. have documented cll/sll according to nci criteria;
Beskrivning

Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2]
C0855095
3. recurrent or refractory disease according to nci criteria;
Beskrivning

Refractory Disease | Recurrent disease | leukemia

Datatyp

boolean

Alias
UMLS CUI [1]
C1514815
UMLS CUI [2]
C0277556
UMLS CUI [3]
C0023418
4. patient are eligible if they have received one or more prior treatment;
Beskrivning

prior treatment; one

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0023434
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0855095
5. ecog performance status of 0-2 (appendix 1);
Beskrivning

ecog performance status; appendix

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
6. life expectancy > 6 months;
Beskrivning

life expectancy > 6 months

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
7. adequate renal function indicated by serum creatinine less or equal to 2 mg/dl;
Beskrivning

adequate renal function; serum creatinine

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
8. adequate hepatic function indicated as total bilirubin less or equal to 2 mg/dl and alt/gpt less or equal to two times the upper normal limit;
Beskrivning

adequate hepatic function; total bilirubin;

Datatyp

boolean

Alias
UMLS CUI [1]
C0201913
9. disease free of prior malignancies for 3 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 or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality received
Beskrivning

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.; disease free of prior malignancies for ? 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0553723
UMLS CUI [3]
C0851140
UMLS CUI [4]
C0154084
10. no prior history of myelodysplastic syndrome or other myeloid malignancy;
Beskrivning

MYELODYSPLASTIC SYNDROME | Myeloid neoplasm

Datatyp

boolean

Alias
UMLS CUI [1]
C3463824
UMLS CUI [2]
C2939461
11. all participants must be registered into the mandatory revlimid rems® program, and be willing and able to comply with the requirements of the revlimid rems ®;
Beskrivning

able to comply with the requirements of the protocol.; able to comply with the protocol; participants; all

Datatyp

boolean

Alias
UMLS CUI [1]
C0421512
UMLS CUI [2]
C1321605
12. females of childbearing potential (fcbp) must have a negative serum and/or urine pregnancy test with a sensitive of at least 50 miu/ml within 10-14 days and again within 24 hours prior to prescribe lenalidomide for cycle 1 (prescriptions must be filled within 7 days as required by revlimid rems®) 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 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.
Beskrivning

childbearing potential; pregnancy test; lenalidomide; negative; ongoing; testing; method; sexual; agree; serum; begin; urine; cycle; latex; time; from; miu; one

Datatyp

boolean

Alias
UMLS CUI [1]
C1960468
UMLS CUI [2]
C0430064
UMLS CUI [3]
C0430056
UMLS CUI [4]
C0036899
UMLS CUI [5]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. known sensitivity to lenalidomide or other thalidomide derivatives or anti cd20;
Beskrivning

Sensitivity to lenalidomide; thalidomide;

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1144149
UMLS CUI [1,2]
C0332324
UMLS CUI [2,1]
C0039736
UMLS CUI [2,2]
C0332324
UMLS CUI [3,1]
C2742503
UMLS CUI [3,2]
C0332324
2. documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood);
Beskrivning

prolymphocytic leukemia; prolymphocytes; blood

Datatyp

boolean

Alias
UMLS CUI [1]
C0023486
3. known history of infection with human immunodeficiency virus (hiv) or human t cell leukemia virus 1 (htlv-1);
Beskrivning

HIV | Human T-lymphotropic virus 1

Datatyp

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0020094
4. serologic status reflecting active hepatitis b or c. patients with hepatitis b (hbv) antibody positive but who have positivity for hepatitis b surface antigen (hbsag) or anti hepatitis b core antibody (anti-hbc) and patients who are positive for anti-hcv will need to have a negative pcr (viral hbv dna or hcv rna) result prior to enrollment. those who are hbsag positive or hbv dna positive and those who are positive for hcv (rna) will be excluded;
Beskrivning

Hepatitis B | Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
5. pregnant or breast feeding females;
Beskrivning

pregnant or breast feeding woman; pregnant or breast feeding women

Datatyp

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0006147
6. history of tuberculosis treated within the last five years or recent exposure to tuberculosis;
Beskrivning

tuberculosis; exposure; last

Datatyp

boolean

Alias
UMLS CUI [1]
C0041296
7. any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject unacceptable risk if he/she were to participate to the study;
Beskrivning

medical condition; patient risk management

Datatyp

boolean

Alias
UMLS CUI [1]
C0814475
8. patients with a recent history of deep vein thrombosis or pulmonary embolus, in the six months prior to enrollment are not eligible for this study.
Beskrivning

Deep Vein Thrombosis | Pulmonary Embolism

Datatyp

boolean

Alias
UMLS CUI [1]
C0149871
UMLS CUI [2]
C0034065
Tillbaka till toppen

Similar models

Eligibility Leukemia NCT02225275

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02225275
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Informed Consent
Item
1. age 18 years or older at the time of signing informed consent. able to understand and to provide voluntarily informed consent;
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma
Item
2. have documented cll/sll according to nci criteria;
boolean
C0023434 (UMLS CUI [1])
C0855095 (UMLS CUI [2])
Refractory Disease | Recurrent disease | leukemia
Item
3. recurrent or refractory disease according to nci criteria;
boolean
C1514815 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C0023418 (UMLS CUI [3])
prior treatment; one
Item
4. patient are eligible if they have received one or more prior treatment;
boolean
C1514463 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0855095 (UMLS CUI [2,2])
ecog performance status; appendix
Item
5. ecog performance status of 0-2 (appendix 1);
boolean
C1520224 (UMLS CUI [1])
life expectancy > 6 months
Item
6. life expectancy > 6 months;
boolean
C0023671 (UMLS CUI [1])
adequate renal function; serum creatinine
Item
7. adequate renal function indicated by serum creatinine less or equal to 2 mg/dl;
boolean
C0201976 (UMLS CUI [1])
adequate hepatic function; total bilirubin;
Item
8. adequate hepatic function indicated as total bilirubin less or equal to 2 mg/dl and alt/gpt less or equal to two times the upper normal limit;
boolean
C0201913 (UMLS CUI [1])
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.; disease free of prior malignancies for ? 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma
Item
9. disease free of prior malignancies for 3 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 or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality received
boolean
C0006826 (UMLS CUI [1])
C0553723 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
C0154084 (UMLS CUI [4])
MYELODYSPLASTIC SYNDROME | Myeloid neoplasm
Item
10. no prior history of myelodysplastic syndrome or other myeloid malignancy;
boolean
C3463824 (UMLS CUI [1])
C2939461 (UMLS CUI [2])
able to comply with the requirements of the protocol.; able to comply with the protocol; participants; all
Item
11. all participants must be registered into the mandatory revlimid rems® program, and be willing and able to comply with the requirements of the revlimid rems ®;
boolean
C0421512 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
childbearing potential; pregnancy test; lenalidomide; negative; ongoing; testing; method; sexual; agree; serum; begin; urine; cycle; latex; time; from; miu; one
Item
12. females of childbearing potential (fcbp) must have a negative serum and/or urine pregnancy test with a sensitive of at least 50 miu/ml within 10-14 days and again within 24 hours prior to prescribe lenalidomide for cycle 1 (prescriptions must be filled within 7 days as required by revlimid rems®) 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 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
C1960468 (UMLS CUI [1])
C0430064 (UMLS CUI [2])
C0430056 (UMLS CUI [3])
C0036899 (UMLS CUI [4])
C0700589 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Sensitivity to lenalidomide; thalidomide;
Item
1. known sensitivity to lenalidomide or other thalidomide derivatives or anti cd20;
boolean
C1144149 (UMLS CUI [1,1])
C0332324 (UMLS CUI [1,2])
C0039736 (UMLS CUI [2,1])
C0332324 (UMLS CUI [2,2])
C2742503 (UMLS CUI [3,1])
C0332324 (UMLS CUI [3,2])
prolymphocytic leukemia; prolymphocytes; blood
Item
2. documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood);
boolean
C0023486 (UMLS CUI [1])
HIV | Human T-lymphotropic virus 1
Item
3. known history of infection with human immunodeficiency virus (hiv) or human t cell leukemia virus 1 (htlv-1);
boolean
C0019682 (UMLS CUI [1])
C0020094 (UMLS CUI [2])
Hepatitis B | Hepatitis C
Item
4. serologic status reflecting active hepatitis b or c. patients with hepatitis b (hbv) antibody positive but who have positivity for hepatitis b surface antigen (hbsag) or anti hepatitis b core antibody (anti-hbc) and patients who are positive for anti-hcv will need to have a negative pcr (viral hbv dna or hcv rna) result prior to enrollment. those who are hbsag positive or hbv dna positive and those who are positive for hcv (rna) will be excluded;
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
pregnant or breast feeding woman; pregnant or breast feeding women
Item
5. pregnant or breast feeding females;
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
tuberculosis; exposure; last
Item
6. history of tuberculosis treated within the last five years or recent exposure to tuberculosis;
boolean
C0041296 (UMLS CUI [1])
medical condition; patient risk management
Item
7. any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject unacceptable risk if he/she were to participate to the study;
boolean
C0814475 (UMLS CUI [1])
Deep Vein Thrombosis | Pulmonary Embolism
Item
8. patients with a recent history of deep vein thrombosis or pulmonary embolus, in the six months prior to enrollment are not eligible for this study.
boolean
C0149871 (UMLS CUI [1])
C0034065 (UMLS CUI [2])
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