ID

30243

Beskrivning

Bendamustine Combined With Alemtuzumab in Pretreated Chronic Lymphocytic Leukemia (CLL); ODM derived from: https://clinicaltrials.gov/show/NCT00951457

Länk

https://clinicaltrials.gov/show/NCT00951457

Nyckelord

Versioner (2)
  1. 2018-05-23 2018-05-23 -
  2. 2018-05-24 2018-05-24 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

24 maj 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Leukemia, Lymphocytic, Chronic, B-Cell NCT00951457

Engelsk

Eligibility Leukemia, Lymphocytic, Chronic, B-Cell NCT00951457

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients with cd23+, cd5+, cd19+ light chain monoclonal b-cll with treatment indication according to iwcll criteria (appendix 4)
Beskrivning

Chronic Lymphocytic Leukemia Monoclonal free light chain present CD23 positive | Chronic Lymphocytic Leukemia Monoclonal free light chain present CD5 positive | Chronic Lymphocytic Leukemia Monoclonal free light chain present CD19 positive | Indication Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C1532998
UMLS CUI [1,3]
C0945924
UMLS CUI [2,1]
C0023434
UMLS CUI [2,2]
C1532998
UMLS CUI [2,3]
C0882892
UMLS CUI [3,1]
C0023434
UMLS CUI [3,2]
C1532998
UMLS CUI [3,3]
C0882808
UMLS CUI [4,1]
C3146298
UMLS CUI [4,2]
C0087111
1st or greater relapse after fludarabine or any other primary treatment regimen or refractory to any previous treatment and simultaneous indication for treatment according to iwcll criteria (appendix 4)
Beskrivning

Relapse Ordinal number | Fludarabine | First line treatment | Refractory Disease | Indication Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C0439080
UMLS CUI [2]
C0059985
UMLS CUI [3]
C1708063
UMLS CUI [4]
C1514815
UMLS CUI [5,1]
C3146298
UMLS CUI [5,2]
C0087111
age 18 years and older
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog status 0 - 2
Beskrivning

ECOG performance status

Datatyp

boolean

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

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
written informed consent given by the patient
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
patient using a reliable means of contraception (e.g. physical barrier, contraceptive pill or patch, spermicide and barrier, or iud) for the duration of the study. male patients have to use an adequate contraception method for the duration of study treatment and for 6 months following completion of study treatment. women of childbearing potential have to use an effective method of contraception for the duration of study participation.
Beskrivning

Contraceptive methods | Contraception, Barrier | Oral contraception | Contraceptive Patch | Spermatocidal Agents | Intrauterine Devices | Gender Contraceptive methods | Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C0004764
UMLS CUI [3]
C0029151
UMLS CUI [4]
C2985284
UMLS CUI [5]
C0037862
UMLS CUI [6]
C0021900
UMLS CUI [7,1]
C0079399
UMLS CUI [7,2]
C0700589
UMLS CUI [8,1]
C3831118
UMLS CUI [8,2]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
hiv positive or positive for hepatitis b or c
Beskrivning

HIV Seropositivity | Hepatitis B positive | Hepatitis C positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0856706
UMLS CUI [3]
C1112419
active uncontrolled infection
Beskrivning

Communicable Disease Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
pregnant or lactating women
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
hypersensitivity with anaphylactic reaction to humanised monoclonal antibodies or to the excipients of any of the applied drugs (e.g. bendamustine hydrochloride or mannitol)
Beskrivning

Hypersensitivity Humanized Monoclonal Antibodies | Anaphylaxis Humanized Monoclonal Antibodies | Hypersensitivity Excipient Investigational New Drugs | Anaphylaxis Excipient Investigational New Drugs | Hypersensitivity Bendamustine hydrochloride | Anaphylaxis Bendamustine hydrochloride | Mannitol allergy | Anaphylaxis Mannitol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2985546
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C2985546
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0015237
UMLS CUI [3,3]
C0013230
UMLS CUI [4,1]
C0002792
UMLS CUI [4,2]
C0015237
UMLS CUI [4,3]
C0013230
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0772139
UMLS CUI [6,1]
C0002792
UMLS CUI [6,2]
C0772139
UMLS CUI [7]
C0571922
UMLS CUI [8,1]
C0002792
UMLS CUI [8,2]
C0024730
previous treatment with bendamustine
Beskrivning

Prior Therapy Bendamustine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0525079
treatment with an experimental drug within the previous 2 months
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis dcis of the breast treated with lumpectomy alone with curative intent.
Beskrivning

Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Prostate carcinoma Low grade Curative procedure intent | Exception DCIS Lumpectomy

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0600139
UMLS CUI [5,3]
C1282907
UMLS CUI [5,4]
C1276305
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0007124
UMLS CUI [6,3]
C0024885
transformation to aggressive b-cell malignancy (e.g. large b-cell lymphoma, richter's syndrome, or prolymphocytic leukemia (pll)
Beskrivning

Transformation B cell Aggressive malignancy | Diffuse Large B-Cell Lymphoma | Richter's syndrome | Prolymphocytic Leukemia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040682
UMLS CUI [1,2]
C0004561
UMLS CUI [1,3]
C3149729
UMLS CUI [2]
C0079744
UMLS CUI [3]
C0349631
UMLS CUI [4]
C0023486
decreased kidney function with creatinine clearance < 30 ml/min
Beskrivning

Decreased renal function | Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0232807
UMLS CUI [2]
C0373595
patients with severe co-morbidities or major organ dysfunctions (e.g. known severe liver damage, jaundice)
Beskrivning

Comorbidity Severe | Dysfunction Organ Major | Liver damage Severe | Icterus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C3887504
UMLS CUI [2,2]
C0178784
UMLS CUI [2,3]
C0205164
UMLS CUI [3,1]
C0151763
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0022346
patients with a history of severe cardiac disease; e.g. nyha functional class iii or iv heart failure, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, or unstable angina
Beskrivning

Heart Disease Severe | Heart failure New York Heart Association Classification | Myocardial Infarction | Ventricular Tachycardia Treatment required for | Angina, Unstable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C0027051
UMLS CUI [4,1]
C0042514
UMLS CUI [4,2]
C0332121
UMLS CUI [5]
C0002965
any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent, or patients unable to comply with requirements of study protocol
Beskrivning

Medical condition Study Subject Participation Status Excluded | Mental condition Study Subject Participation Status Excluded | Medical condition compromises Informed Consent | Mental condition compromises Informed Consent | Protocol Compliance Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0332196
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C0021430
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C2945640
UMLS CUI [4,3]
C0021430
UMLS CUI [5,1]
C0525058
UMLS CUI [5,2]
C1299582
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Similar models

Eligibility Leukemia, Lymphocytic, Chronic, B-Cell NCT00951457

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia Monoclonal free light chain present CD23 positive | Chronic Lymphocytic Leukemia Monoclonal free light chain present CD5 positive | Chronic Lymphocytic Leukemia Monoclonal free light chain present CD19 positive | Indication Therapeutic procedure
Item
male or female patients with cd23+, cd5+, cd19+ light chain monoclonal b-cll with treatment indication according to iwcll criteria (appendix 4)
boolean
C0023434 (UMLS CUI [1,1])
C1532998 (UMLS CUI [1,2])
C0945924 (UMLS CUI [1,3])
C0023434 (UMLS CUI [2,1])
C1532998 (UMLS CUI [2,2])
C0882892 (UMLS CUI [2,3])
C0023434 (UMLS CUI [3,1])
C1532998 (UMLS CUI [3,2])
C0882808 (UMLS CUI [3,3])
C3146298 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
Relapse Ordinal number | Fludarabine | First line treatment | Refractory Disease | Indication Therapeutic procedure
Item
1st or greater relapse after fludarabine or any other primary treatment regimen or refractory to any previous treatment and simultaneous indication for treatment according to iwcll criteria (appendix 4)
boolean
C0035020 (UMLS CUI [1,1])
C0439080 (UMLS CUI [1,2])
C0059985 (UMLS CUI [2])
C1708063 (UMLS CUI [3])
C1514815 (UMLS CUI [4])
C3146298 (UMLS CUI [5,1])
C0087111 (UMLS CUI [5,2])
Age
Item
age 18 years and older
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog status 0 - 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 6 months
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
written informed consent given by the patient
boolean
C0021430 (UMLS CUI [1])
Contraceptive methods | Contraception, Barrier | Oral contraception | Contraceptive Patch | Spermatocidal Agents | Intrauterine Devices | Gender Contraceptive methods | Childbearing Potential Contraceptive methods
Item
patient using a reliable means of contraception (e.g. physical barrier, contraceptive pill or patch, spermicide and barrier, or iud) for the duration of the study. male patients have to use an adequate contraception method for the duration of study treatment and for 6 months following completion of study treatment. women of childbearing potential have to use an effective method of contraception for the duration of study participation.
boolean
C0700589 (UMLS CUI [1])
C0004764 (UMLS CUI [2])
C0029151 (UMLS CUI [3])
C2985284 (UMLS CUI [4])
C0037862 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0079399 (UMLS CUI [7,1])
C0700589 (UMLS CUI [7,2])
C3831118 (UMLS CUI [8,1])
C0700589 (UMLS CUI [8,2])
Item Group
C0680251 (UMLS CUI)
HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
Item
hiv positive or positive for hepatitis b or c
boolean
C0019699 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Communicable Disease Uncontrolled
Item
active uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity Humanized Monoclonal Antibodies | Anaphylaxis Humanized Monoclonal Antibodies | Hypersensitivity Excipient Investigational New Drugs | Anaphylaxis Excipient Investigational New Drugs | Hypersensitivity Bendamustine hydrochloride | Anaphylaxis Bendamustine hydrochloride | Mannitol allergy | Anaphylaxis Mannitol
Item
hypersensitivity with anaphylactic reaction to humanised monoclonal antibodies or to the excipients of any of the applied drugs (e.g. bendamustine hydrochloride or mannitol)
boolean
C0020517 (UMLS CUI [1,1])
C2985546 (UMLS CUI [1,2])
C0002792 (UMLS CUI [2,1])
C2985546 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0015237 (UMLS CUI [3,2])
C0013230 (UMLS CUI [3,3])
C0002792 (UMLS CUI [4,1])
C0015237 (UMLS CUI [4,2])
C0013230 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C0772139 (UMLS CUI [5,2])
C0002792 (UMLS CUI [6,1])
C0772139 (UMLS CUI [6,2])
C0571922 (UMLS CUI [7])
C0002792 (UMLS CUI [8,1])
C0024730 (UMLS CUI [8,2])
Prior Therapy Bendamustine
Item
previous treatment with bendamustine
boolean
C1514463 (UMLS CUI [1,1])
C0525079 (UMLS CUI [1,2])
Investigational New Drugs
Item
treatment with an experimental drug within the previous 2 months
boolean
C0013230 (UMLS CUI [1])
Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Prostate carcinoma Low grade Curative procedure intent | Exception DCIS Lumpectomy
Item
patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis dcis of the breast treated with lumpectomy alone with curative intent.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0600139 (UMLS CUI [5,2])
C1282907 (UMLS CUI [5,3])
C1276305 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0007124 (UMLS CUI [6,2])
C0024885 (UMLS CUI [6,3])
Transformation B cell Aggressive malignancy | Diffuse Large B-Cell Lymphoma | Richter's syndrome | Prolymphocytic Leukemia
Item
transformation to aggressive b-cell malignancy (e.g. large b-cell lymphoma, richter's syndrome, or prolymphocytic leukemia (pll)
boolean
C0040682 (UMLS CUI [1,1])
C0004561 (UMLS CUI [1,2])
C3149729 (UMLS CUI [1,3])
C0079744 (UMLS CUI [2])
C0349631 (UMLS CUI [3])
C0023486 (UMLS CUI [4])
Decreased renal function | Creatinine clearance measurement
Item
decreased kidney function with creatinine clearance < 30 ml/min
boolean
C0232807 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Comorbidity Severe | Dysfunction Organ Major | Liver damage Severe | Icterus
Item
patients with severe co-morbidities or major organ dysfunctions (e.g. known severe liver damage, jaundice)
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3887504 (UMLS CUI [2,1])
C0178784 (UMLS CUI [2,2])
C0205164 (UMLS CUI [2,3])
C0151763 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0022346 (UMLS CUI [4])
Heart Disease Severe | Heart failure New York Heart Association Classification | Myocardial Infarction | Ventricular Tachycardia Treatment required for | Angina, Unstable
Item
patients with a history of severe cardiac disease; e.g. nyha functional class iii or iv heart failure, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, or unstable angina
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0042514 (UMLS CUI [4,1])
C0332121 (UMLS CUI [4,2])
C0002965 (UMLS CUI [5])
Medical condition Study Subject Participation Status Excluded | Mental condition Study Subject Participation Status Excluded | Medical condition compromises Informed Consent | Mental condition compromises Informed Consent | Protocol Compliance Unable
Item
any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent, or patients unable to comply with requirements of study protocol
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C0021430 (UMLS CUI [4,3])
C0525058 (UMLS CUI [5,1])
C1299582 (UMLS CUI [5,2])
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