ID

14937

Beskrivning

Ibrutinib in Combination With GA101 (Obinutuzumab) in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Patients.; ODM derived from: https://clinicaltrials.gov/show/NCT02315768

Länk

https://clinicaltrials.gov/show/NCT02315768

Nyckelord

Versioner (1)
  1. 2016-05-09 2016-05-09 -
Uppladdad den

9 maj 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia NCT02315768

Engelsk

Eligibility Chronic Lymphocytic Leukemia NCT02315768

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of cll
Beskrivning

Chronic Lymphocytic Leukemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0023434
2. indication for treatment as defined by the international workshop on chronic lymphocytic leukaemia (iwcll) guidelines
Beskrivning

Indication Therapeutic procedure | Chronic Lymphocytic Leukemia Guidelines

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0087111
UMLS CUI [2,1]
C0023434
UMLS CUI [2,2]
C0162791
3. no previous treatment for cll
Beskrivning

Prior Therapy Chronic Lymphocytic Leukemia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0023434
4. males and females 65 years of age and older. subjects over 65 years of age that meet any of the following criteria:
Beskrivning

Age | criteria following

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C0332282
a. documented refusal to be treated with chemotherapy agents b. subjects that are not candidates for treatment with chemotherapy based on poor performance status (ecog g>= 2), cumulative illness rating scale (cirs score) >= 6 or creatinine clearance less than 70 ml/min
Beskrivning

Refusal of Treatment Antineoplastic Agents | Chemotherapy Regimen | ECOG performance status | Rating scale Illness Cumulative | Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040809
UMLS CUI [1,2]
C0003392
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1520224
UMLS CUI [4,1]
C0681889
UMLS CUI [4,2]
C0221423
UMLS CUI [4,3]
C1511559
UMLS CUI [5]
C0373595
5. laboratory parameters as specified below:
Beskrivning

Laboratory parameters following

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0449381
UMLS CUI [1,3]
C0332282
hematologic: hemoglobin > 8 g/dl (may be post-transfusion); platelet count > 40 x103/mm3 (may be post-transfusion). absolute neutrophil count > 1.0 109 cells/l (growth factor use is allowed)
Beskrivning

Hematologic | Hemoglobin | Platelet Count measurement | post transfusion | Absolute neutrophil count | Growth Factor

Datatyp

boolean

Alias
UMLS CUI [1]
C0205488
UMLS CUI [2]
C0019046
UMLS CUI [3]
C0032181
UMLS CUI [4]
C1979579
UMLS CUI [5]
C0948762
UMLS CUI [6]
C0018284
hepatic: total bilirubin < 3 x uln, and alt and ast < 3 x uln
Beskrivning

Hepatic | Bilirubin, total measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Upper Limit of Normal

Datatyp

boolean

Alias
UMLS CUI [1]
C0205054
UMLS CUI [2]
C0201913
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201899
UMLS CUI [5]
C1519815
renal: creatinine clearance > 30 ml/min (calculated according to institutional standards or using cockcroft-gault formula. subjects with requirement of hemodialysis will be excluded)
Beskrivning

Kidney | Creatinine clearance measurement | Creatinine renal clearance.predicted:VRat:Pt:Ser/Plas:Qn:Cockcroft-Gault formula | Requirement Hemodialysis

Datatyp

boolean

Alias
UMLS CUI [1]
C0022646
UMLS CUI [2]
C0373595
UMLS CUI [3]
C1507751
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0019004
6. anticipated survival of at least 6 months
Beskrivning

Continuance of life Anticipated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038952
UMLS CUI [1,2]
C3840775
7. effective contraception is required while receiving ibrutinib in combination with ga101-obinutuzumab. for women of childbearing potential and men, effective contraception is required while receiving ga101-obinutuzumab and for 365 days (12 months) after the last dose of the study drug
Beskrivning

Contraceptive methods | Ibrutinib Combined obinutuzumab | Childbearing Potential Requirement Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2,1]
C3501358
UMLS CUI [2,2]
C0205195
UMLS CUI [2,3]
C2742503
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant or nursing women
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. treatment with chemotherapy, monoclonal antibodies, or biological agents (e.g. lenalidomide) other than the investigational agents during the time of participation in this trial
Beskrivning

Therapeutic procedure | Chemotherapy Regimen | Monoclonal Antibodies | Biological Factors | lenalidomide | Investigational New Drugs | Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0087111
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0003250
UMLS CUI [4]
C0005515
UMLS CUI [5]
C1144149
UMLS CUI [6]
C0013230
UMLS CUI [7]
C2348568
3. grade 3 or 4 cardiac disease as defined by the new york heart association functional classification
Beskrivning

Heart Diseases | New York Heart Association Class III | New York Heart Association Class IV

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C1882086
UMLS CUI [3]
C1882087
4. severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, copd)
Beskrivning

Lung diseases Severe | Resting Dyspnea | Dyspnea | Chronic Obstructive Airway Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0743330
UMLS CUI [3]
C0013404
UMLS CUI [4]
C0024117
5. participation in any investigational drug study within 28 days prior to initiation of treatment within this protocol. (subject must have recovered from all acute effects of previously administered investigational agents)
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
6. history of second malignancy, other than non-melanoma skin cancer or in situ carcinoma of the cervix or the breast, unless the tumor was successfully treated at least 2 years before trial entry and with no evidence of relapse or active cancer.
Beskrivning

Neoplasms, Second Primary | Malignant neoplasm of skin | Carcinoma in situ of uterine cervix | Stage 0 Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0085183
UMLS CUI [2]
C0007114
UMLS CUI [3]
C0851140
UMLS CUI [4]
C0154084
7. active symptomatic fungal, bacterial and/or viral infection including evidence of infection with hiv, human t-cell leukemia virus 1 (htlv-1) seropositive status.
Beskrivning

Mycoses | Bacterial Infections | Virus Diseases | HIV Infections Seropositive | HTLV-I Infections Seropositive

Datatyp

boolean

Alias
UMLS CUI [1]
C0026946
UMLS CUI [2]
C0004623
UMLS CUI [3]
C0042769
UMLS CUI [4,1]
C0019693
UMLS CUI [4,2]
C0521143
UMLS CUI [5,1]
C0020097
UMLS CUI [5,2]
C0521143
8. evidence of active acute or chronic hepatitis b (hbv)
Beskrivning

Acute type B viral hepatitis | Chronic Hepatitis B

Datatyp

boolean

Alias
UMLS CUI [1]
C0276609
UMLS CUI [2]
C0524909
9. evidence of active hepatitis c (hcv): subjects with positive hepatitis c serology and positive hcv rna test
Beskrivning

Hepatitis C | hepatitis C serology test Positive | Hepatitis C RNA Quantification Test Positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2,1]
C0850489
UMLS CUI [2,2]
C1446409
UMLS CUI [3,1]
C1256156
UMLS CUI [3,2]
C1446409
10. history of severe allergic or anaphylactic reactions to monoclonal antibody therapy
Beskrivning

Allergic Reaction Monoclonal Antibody Therapy | anaphylaxis Monoclonal Antibody Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0279694
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C0279694
11. known hypersensitivity to any of the study drugs
Beskrivning

Hypersensitivity Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
12. major surgery (within 4 weeks prior to the start of cycle 1), except for procedures that are performed for diagnostic purposes
Beskrivning

major surgery | diagnostic procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0430022
13. vaccination with a live vaccine within 28 days of the initiation of treatment.
Beskrivning

Vaccination Vaccines, Attenuated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0042211
14. concomitant use of warfarin or other vitamin k antagonists
Beskrivning

Warfarin | Vitamin K antagonists

Datatyp

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2]
C3653316
15. requirement to receive treatment with a strong cytochrome p450 (cyp) 3a inhibitor
Beskrivning

Requirement Therapeutic procedure Cytochrome P-450 CYP3A Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C3850056
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Similar models

Eligibility Chronic Lymphocytic Leukemia NCT02315768

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia
Item
1. diagnosis of cll
boolean
C0023434 (UMLS CUI [1])
Indication Therapeutic procedure | Chronic Lymphocytic Leukemia Guidelines
Item
2. indication for treatment as defined by the international workshop on chronic lymphocytic leukaemia (iwcll) guidelines
boolean
C3146298 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0023434 (UMLS CUI [2,1])
C0162791 (UMLS CUI [2,2])
Prior Therapy Chronic Lymphocytic Leukemia
Item
3. no previous treatment for cll
boolean
C1514463 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
Age | criteria following
Item
4. males and females 65 years of age and older. subjects over 65 years of age that meet any of the following criteria:
boolean
C0001779 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C0332282 (UMLS CUI [2,2])
Refusal of Treatment Antineoplastic Agents | Chemotherapy Regimen | ECOG performance status | Rating scale Illness Cumulative | Creatinine clearance measurement
Item
a. documented refusal to be treated with chemotherapy agents b. subjects that are not candidates for treatment with chemotherapy based on poor performance status (ecog g>= 2), cumulative illness rating scale (cirs score) >= 6 or creatinine clearance less than 70 ml/min
boolean
C0040809 (UMLS CUI [1,1])
C0003392 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
C1520224 (UMLS CUI [3])
C0681889 (UMLS CUI [4,1])
C0221423 (UMLS CUI [4,2])
C1511559 (UMLS CUI [4,3])
C0373595 (UMLS CUI [5])
Laboratory parameters following
Item
5. laboratory parameters as specified below:
boolean
C0022877 (UMLS CUI [1,1])
C0449381 (UMLS CUI [1,2])
C0332282 (UMLS CUI [1,3])
Hematologic | Hemoglobin | Platelet Count measurement | post transfusion | Absolute neutrophil count | Growth Factor
Item
hematologic: hemoglobin > 8 g/dl (may be post-transfusion); platelet count > 40 x103/mm3 (may be post-transfusion). absolute neutrophil count > 1.0 109 cells/l (growth factor use is allowed)
boolean
C0205488 (UMLS CUI [1])
C0019046 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C1979579 (UMLS CUI [4])
C0948762 (UMLS CUI [5])
C0018284 (UMLS CUI [6])
Hepatic | Bilirubin, total measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Upper Limit of Normal
Item
hepatic: total bilirubin < 3 x uln, and alt and ast < 3 x uln
boolean
C0205054 (UMLS CUI [1])
C0201913 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C1519815 (UMLS CUI [5])
Kidney | Creatinine clearance measurement | Creatinine renal clearance.predicted:VRat:Pt:Ser/Plas:Qn:Cockcroft-Gault formula | Requirement Hemodialysis
Item
renal: creatinine clearance > 30 ml/min (calculated according to institutional standards or using cockcroft-gault formula. subjects with requirement of hemodialysis will be excluded)
boolean
C0022646 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
C1507751 (UMLS CUI [3])
C1514873 (UMLS CUI [4,1])
C0019004 (UMLS CUI [4,2])
Continuance of life Anticipated
Item
6. anticipated survival of at least 6 months
boolean
C0038952 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
Contraceptive methods | Ibrutinib Combined obinutuzumab | Childbearing Potential Requirement Contraceptive methods
Item
7. effective contraception is required while receiving ibrutinib in combination with ga101-obinutuzumab. for women of childbearing potential and men, effective contraception is required while receiving ga101-obinutuzumab and for 365 days (12 months) after the last dose of the study drug
boolean
C0700589 (UMLS CUI [1])
C3501358 (UMLS CUI [2,1])
C0205195 (UMLS CUI [2,2])
C2742503 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
1. pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Therapeutic procedure | Chemotherapy Regimen | Monoclonal Antibodies | Biological Factors | lenalidomide | Investigational New Drugs | Study Subject Participation Status
Item
2. treatment with chemotherapy, monoclonal antibodies, or biological agents (e.g. lenalidomide) other than the investigational agents during the time of participation in this trial
boolean
C0087111 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0003250 (UMLS CUI [3])
C0005515 (UMLS CUI [4])
C1144149 (UMLS CUI [5])
C0013230 (UMLS CUI [6])
C2348568 (UMLS CUI [7])
Heart Diseases | New York Heart Association Class III | New York Heart Association Class IV
Item
3. grade 3 or 4 cardiac disease as defined by the new york heart association functional classification
boolean
C0018799 (UMLS CUI [1])
C1882086 (UMLS CUI [2])
C1882087 (UMLS CUI [3])
Lung diseases Severe | Resting Dyspnea | Dyspnea | Chronic Obstructive Airway Disease
Item
4. severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, copd)
boolean
C0024115 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0743330 (UMLS CUI [2])
C0013404 (UMLS CUI [3])
C0024117 (UMLS CUI [4])
Study Subject Participation Status
Item
5. participation in any investigational drug study within 28 days prior to initiation of treatment within this protocol. (subject must have recovered from all acute effects of previously administered investigational agents)
boolean
C2348568 (UMLS CUI [1])
Neoplasms, Second Primary | Malignant neoplasm of skin | Carcinoma in situ of uterine cervix | Stage 0 Breast Carcinoma
Item
6. history of second malignancy, other than non-melanoma skin cancer or in situ carcinoma of the cervix or the breast, unless the tumor was successfully treated at least 2 years before trial entry and with no evidence of relapse or active cancer.
boolean
C0085183 (UMLS CUI [1])
C0007114 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
C0154084 (UMLS CUI [4])
Mycoses | Bacterial Infections | Virus Diseases | HIV Infections Seropositive | HTLV-I Infections Seropositive
Item
7. active symptomatic fungal, bacterial and/or viral infection including evidence of infection with hiv, human t-cell leukemia virus 1 (htlv-1) seropositive status.
boolean
C0026946 (UMLS CUI [1])
C0004623 (UMLS CUI [2])
C0042769 (UMLS CUI [3])
C0019693 (UMLS CUI [4,1])
C0521143 (UMLS CUI [4,2])
C0020097 (UMLS CUI [5,1])
C0521143 (UMLS CUI [5,2])
Acute type B viral hepatitis | Chronic Hepatitis B
Item
8. evidence of active acute or chronic hepatitis b (hbv)
boolean
C0276609 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
Hepatitis C | hepatitis C serology test Positive | Hepatitis C RNA Quantification Test Positive
Item
9. evidence of active hepatitis c (hcv): subjects with positive hepatitis c serology and positive hcv rna test
boolean
C0019196 (UMLS CUI [1])
C0850489 (UMLS CUI [2,1])
C1446409 (UMLS CUI [2,2])
C1256156 (UMLS CUI [3,1])
C1446409 (UMLS CUI [3,2])
Allergic Reaction Monoclonal Antibody Therapy | anaphylaxis Monoclonal Antibody Therapy
Item
10. history of severe allergic or anaphylactic reactions to monoclonal antibody therapy
boolean
C1527304 (UMLS CUI [1,1])
C0279694 (UMLS CUI [1,2])
C0002792 (UMLS CUI [2,1])
C0279694 (UMLS CUI [2,2])
Hypersensitivity Investigational New Drugs
Item
11. known hypersensitivity to any of the study drugs
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
major surgery | diagnostic procedure
Item
12. major surgery (within 4 weeks prior to the start of cycle 1), except for procedures that are performed for diagnostic purposes
boolean
C0679637 (UMLS CUI [1])
C0430022 (UMLS CUI [2])
Vaccination Vaccines, Attenuated
Item
13. vaccination with a live vaccine within 28 days of the initiation of treatment.
boolean
C0042196 (UMLS CUI [1,1])
C0042211 (UMLS CUI [1,2])
Warfarin | Vitamin K antagonists
Item
14. concomitant use of warfarin or other vitamin k antagonists
boolean
C0043031 (UMLS CUI [1])
C3653316 (UMLS CUI [2])
Requirement Therapeutic procedure Cytochrome P-450 CYP3A Inhibitors
Item
15. requirement to receive treatment with a strong cytochrome p450 (cyp) 3a inhibitor
boolean
C1514873 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C3850056 (UMLS CUI [1,3])
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