ID

41087

Beskrivning

Allogeneic Stem Cell Transplant for Chronic Lymphocytic Leukemia (CLL); ODM derived from: https://clinicaltrials.gov/show/NCT01629511

Länk

https://clinicaltrials.gov/show/NCT01629511

Nyckelord

Versioner (1)
  1. 2020-06-22 2020-06-22 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

22 juni 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Leukemia NCT01629511

Engelsk

Eligibility Leukemia NCT01629511

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01629511
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age 18 to 70 years of age.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. patients with chronic lymphocytic leukemia, prolymphocytic leukemia, or richter's transformation who are eligible for allogeneic transplantation and are not eligible for protocols of higher priority.
Beskrivning

Chronic Lymphocytic Leukemia | Prolymphocytic Leukemia | Richter's syndrome | Eligibility Allogeneic Transplantation

Datatyp

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2]
C0023486
UMLS CUI [3]
C0349631
UMLS CUI [4,1]
C1548635
UMLS CUI [4,2]
C0040739
3. a 10/10 hla matched (high resolution typing at a, b, c, drb1, dq1) sibling or unrelated donor.
Beskrivning

HLA Match Sibling | HLA Match Unrelated Donors

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4330149
UMLS CUI [1,2]
C0037047
UMLS CUI [2,1]
C4330149
UMLS CUI [2,2]
C3179133
4. left ventricular ef > 40%.
Beskrivning

Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
5. fev1, fvc and corrected dlco > 40%.
Beskrivning

FEV1 | FVC | DLCO

Datatyp

boolean

Alias
UMLS CUI [1]
C0849974
UMLS CUI [2]
C3714541
UMLS CUI [3]
C1516251
6. serum creatinine < 1.6 mg/dl. serum bilirubin < 2x upper limit of normal.
Beskrivning

Creatinine measurement, serum | Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
7. sgpt < 2x upper limit of normal.
Beskrivning

Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201836
8. voluntary signed, written irb-approved informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
9. men and women of reproductive potential must agree to follow accepted birth control methods for the duration of the study. female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. male subject agrees to use an acceptable method for contraception for the duration of the study.
Beskrivning

Females & males of reproductive potential Contraceptive methods | Postmenopausal state | Female Sterilization | Gender Contraceptive methods | Contraceptives, Oral, Hormonal | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Female Condoms | Sexual Abstinence | Gender Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0015787
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0700589
UMLS CUI [5]
C0009907
UMLS CUI [6]
C0021900
UMLS CUI [7]
C0042241
UMLS CUI [8]
C0087145
UMLS CUI [9]
C0221829
UMLS CUI [10]
C0036899
UMLS CUI [11,1]
C0079399
UMLS CUI [11,2]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient with active cns disease.
Beskrivning

CNS disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0007682
2. pregnant (positive beta hcg test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization) or currently breast-feeding. pregnancy testing is not required for post-menopausal or surgically sterilized women.
Beskrivning

Pregnancy | Serum pregnancy test (B-HCG) Positive | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0430060
UMLS CUI [2,2]
C1514241
UMLS CUI [3]
C0006147
3. known infection with hiv, htlv-i, hepatitis b, or hepatitis c.
Beskrivning

HIV Infection | HTLV-I Infection | Hepatitis B | Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0020097
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
4. active uncontrolled bacterial, viral or fungal infections.
Beskrivning

Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0042769
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0026946
UMLS CUI [3,2]
C0205318
5. patient has received other investigational drugs within 2 weeks before enrollment.
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Leukemia NCT01629511

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01629511
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age 18 to 70 years of age.
boolean
C0001779 (UMLS CUI [1])
Chronic Lymphocytic Leukemia | Prolymphocytic Leukemia | Richter's syndrome | Eligibility Allogeneic Transplantation
Item
2. patients with chronic lymphocytic leukemia, prolymphocytic leukemia, or richter's transformation who are eligible for allogeneic transplantation and are not eligible for protocols of higher priority.
boolean
C0023434 (UMLS CUI [1])
C0023486 (UMLS CUI [2])
C0349631 (UMLS CUI [3])
C1548635 (UMLS CUI [4,1])
C0040739 (UMLS CUI [4,2])
HLA Match Sibling | HLA Match Unrelated Donors
Item
3. a 10/10 hla matched (high resolution typing at a, b, c, drb1, dq1) sibling or unrelated donor.
boolean
C4330149 (UMLS CUI [1,1])
C0037047 (UMLS CUI [1,2])
C4330149 (UMLS CUI [2,1])
C3179133 (UMLS CUI [2,2])
Left ventricular ejection fraction
Item
4. left ventricular ef > 40%.
boolean
C0428772 (UMLS CUI [1])
FEV1 | FVC | DLCO
Item
5. fev1, fvc and corrected dlco > 40%.
boolean
C0849974 (UMLS CUI [1])
C3714541 (UMLS CUI [2])
C1516251 (UMLS CUI [3])
Creatinine measurement, serum | Serum total bilirubin measurement
Item
6. serum creatinine < 1.6 mg/dl. serum bilirubin < 2x upper limit of normal.
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
Alanine aminotransferase measurement
Item
7. sgpt < 2x upper limit of normal.
boolean
C0201836 (UMLS CUI [1])
Informed Consent
Item
8. voluntary signed, written irb-approved informed consent.
boolean
C0021430 (UMLS CUI [1])
Females & males of reproductive potential Contraceptive methods | Postmenopausal state | Female Sterilization | Gender Contraceptive methods | Contraceptives, Oral, Hormonal | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Female Condoms | Sexual Abstinence | Gender Contraceptive methods
Item
9. men and women of reproductive potential must agree to follow accepted birth control methods for the duration of the study. female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. male subject agrees to use an acceptable method for contraception for the duration of the study.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0009907 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0042241 (UMLS CUI [7])
C0087145 (UMLS CUI [8])
C0221829 (UMLS CUI [9])
C0036899 (UMLS CUI [10])
C0079399 (UMLS CUI [11,1])
C0700589 (UMLS CUI [11,2])
Item Group
C0680251 (UMLS CUI)
CNS disorder
Item
1. patient with active cns disease.
boolean
C0007682 (UMLS CUI [1])
Pregnancy | Serum pregnancy test (B-HCG) Positive | Breast Feeding
Item
2. pregnant (positive beta hcg test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization) or currently breast-feeding. pregnancy testing is not required for post-menopausal or surgically sterilized women.
boolean
C0032961 (UMLS CUI [1])
C0430060 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3])
HIV Infection | HTLV-I Infection | Hepatitis B | Hepatitis C
Item
3. known infection with hiv, htlv-i, hepatitis b, or hepatitis c.
boolean
C0019693 (UMLS CUI [1])
C0020097 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled
Item
4. active uncontrolled bacterial, viral or fungal infections.
boolean
C0004623 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0042769 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0026946 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Investigational New Drugs
Item
5. patient has received other investigational drugs within 2 weeks before enrollment.
boolean
C0013230 (UMLS CUI [1])
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