ID

30978

Beskrivning

Pilot Study of Reduced Intensity Haematopoietic Stem Cell Transplantation in Patients With Poor Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukaemia (AML) Utilising Conditioning With Fludarabine, Busulphan and Thymoglobulin; ODM derived from: https://clinicaltrials.gov/show/NCT00915811

Länk

https://clinicaltrials.gov/show/NCT00915811

Nyckelord

Versioner (1)
  1. 2018-07-08 2018-07-08 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

8 juli 2018

DOI

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Creative Commons BY 4.0
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Eligibility Myelodysplastic Syndromes NCT00915811

Engelsk

Eligibility Myelodysplastic Syndromes NCT00915811

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient selection
Beskrivning

Patient Selection

Datatyp

boolean

Alias
UMLS CUI [1]
C0242802
1. availability of a hla compatible sibling donor
Beskrivning

Availability of HLA Match Sibling Donor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C4330149
UMLS CUI [1,3]
C0037047
UMLS CUI [1,4]
C0013018
2. age >18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. myelodysplastic syndromes with ipss intermediate-2 or high.
Beskrivning

MYELODYSPLASTIC SYNDROME IPSS

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3463824
UMLS CUI [1,2]
C2827405
4. poor risk acute myeloid leukaemia, de novo or transformed from mds
Beskrivning

Risk Poor AML | AML de novo | MYELODYSPLASTIC SYNDROME transformed AML

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0542537
UMLS CUI [1,3]
C0023467
UMLS CUI [2,1]
C0023467
UMLS CUI [2,2]
C1515568
UMLS CUI [3,1]
C3463824
UMLS CUI [3,2]
C1510411
UMLS CUI [3,3]
C0023467
5. ineligibility for standard conditioning allograft due to age or co-existing morbidities
Beskrivning

Ineligibility Allograft | Age | Comorbidity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512714
UMLS CUI [1,2]
C0040739
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0009488
donor selection
Beskrivning

Donor Selection

Datatyp

boolean

Alias
UMLS CUI [1]
C1449559
1. related donors compatible for hla-a, b, c, drb1 and dqb1 by molecular typing.
Beskrivning

Matched Related Donor HLA-A Molecular Typing | Matched Related Donor HLA-B Molecular Typing | Matched Related Donor HLA-C Molecular Typing | Matched Related Donor HLA-DRB1 Molecular Typing | Matched Related Donor HLA-DQB1 Molecular Typing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4330663
UMLS CUI [1,2]
C0019728
UMLS CUI [1,3]
C2936546
UMLS CUI [2,1]
C4330663
UMLS CUI [2,2]
C0019737
UMLS CUI [2,3]
C2936546
UMLS CUI [3,1]
C4330663
UMLS CUI [3,2]
C0019751
UMLS CUI [3,3]
C2936546
UMLS CUI [4,1]
C4330663
UMLS CUI [4,2]
C0122040
UMLS CUI [4,3]
C2936546
UMLS CUI [5,1]
C4330663
UMLS CUI [5,2]
C0122020
UMLS CUI [5,3]
C2936546
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient selection
Beskrivning

Patient Selection

Datatyp

boolean

Alias
UMLS CUI [1]
C0242802
1. cardiac insufficiency requiring treatment or symptomatic coronary artery disease.
Beskrivning

Heart failure Treatment required for | Coronary Artery Disease Symptomatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C1956346
UMLS CUI [2,2]
C0231220
2. hepatic disease, with ast > 2 times normal.
Beskrivning

Liver disease | Aspartate aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0151904
3. severe hypoxaemia, po2 < 70 mm hg, with decreased dlco < 70% of predicted; or mild hypoxemia, po2 < 80 mm hg with severely decreased dlco < 60% of predicted.
Beskrivning

Hypoxemia Severe | PO2 measurement | Decreased DLCO | Hypoxemia Mild | Decreased DLCO Severely

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0700292
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C1283004
UMLS CUI [3]
C4073175
UMLS CUI [4,1]
C0700292
UMLS CUI [4,2]
C2945599
UMLS CUI [5,1]
C4073175
UMLS CUI [5,2]
C0205082
4. impaired renal function (creatinine > 2 times upper limit of normal or creatinine clearance < 50% for age, gender, weight).
Beskrivning

Renal Insufficiency | Serum creatinine raised | Creatinine clearance measurement | Age | Gender | Body Weight

Datatyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0700225
UMLS CUI [3]
C0373595
UMLS CUI [4]
C0001779
UMLS CUI [5]
C0079399
UMLS CUI [6]
C0005910
5. patients who have received previous treatment with thymoglobuline
Beskrivning

Thymoglobulin

Datatyp

boolean

Alias
UMLS CUI [1]
C0730920
6. hiv-positive patients.
Beskrivning

HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
7. female patients who are pregnant or breast feeding due to risks to foetus from conditioning regimen and potential risks to nursing infants.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
8. life expectancy severely limited by diseases other than mds or mpd.
Beskrivning

Life Expectancy Limitation Severe | Etiology Disease | Exception MYELODYSPLASTIC SYNDROME | Exception Myeloproliferative disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0449295
UMLS CUI [1,3]
C0205082
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0012634
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C3463824
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0027022
9. serious concurrent untreated infection
Beskrivning

Communicable Disease Serious Untreated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0332155
10. patients with limited life expectancy for other reasons
Beskrivning

Life Expectancy Limited Other reasons

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C3845511
11. serious psychiatric/ psychological disorders
Beskrivning

Serious mental illness

Datatyp

boolean

Alias
UMLS CUI [1]
C3841614
12. absence of /inability to provide informed consent
Beskrivning

Informed Consent Absent | Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
donor selection
Beskrivning

Donor Selection

Datatyp

boolean

Alias
UMLS CUI [1]
C1449559
1. age >75 years, unless independently assessed to be medically fit to donate
Beskrivning

Age | Exception Fit Tissue Donation

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0424576
UMLS CUI [2,3]
C0080231
2. donors who for any reason are unable to tolerate the leukapheresis procedure and cannot undergo anaesthesia for marrow harvest.
Beskrivning

Donor Leukapheresis Unable | Donor Anesthesia Unable | Anesthesia Bone marrow harvest

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013018
UMLS CUI [1,2]
C0023416
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0013018
UMLS CUI [2,2]
C0002903
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C0002903
UMLS CUI [3,2]
C0194015
3. donors who are hiv-positive, or hepatitis b or c pcr positive.
Beskrivning

Donor HIV Seropositivity | Donor Blood hepatitis B virus detection by polymerase chain reaction test | Donor Serum hepatitis C detection by polymerase chain reaction test

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013018
UMLS CUI [1,2]
C0019699
UMLS CUI [2,1]
C0013018
UMLS CUI [2,2]
C2120948
UMLS CUI [3,1]
C0013018
UMLS CUI [3,2]
C2098826
4. donors who are medically unsuitable to donate
Beskrivning

Donor Medically unfit Tissue Donation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013018
UMLS CUI [1,2]
C3841806
UMLS CUI [1,3]
C0080231
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Similar models

Eligibility Myelodysplastic Syndromes NCT00915811

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Patient Selection
Item
patient selection
boolean
C0242802 (UMLS CUI [1])
Availability of HLA Match Sibling Donor
Item
1. availability of a hla compatible sibling donor
boolean
C0470187 (UMLS CUI [1,1])
C4330149 (UMLS CUI [1,2])
C0037047 (UMLS CUI [1,3])
C0013018 (UMLS CUI [1,4])
Age
Item
2. age >18 years
boolean
C0001779 (UMLS CUI [1])
MYELODYSPLASTIC SYNDROME IPSS
Item
3. myelodysplastic syndromes with ipss intermediate-2 or high.
boolean
C3463824 (UMLS CUI [1,1])
C2827405 (UMLS CUI [1,2])
Risk Poor AML | AML de novo | MYELODYSPLASTIC SYNDROME transformed AML
Item
4. poor risk acute myeloid leukaemia, de novo or transformed from mds
boolean
C0035647 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C0023467 (UMLS CUI [1,3])
C0023467 (UMLS CUI [2,1])
C1515568 (UMLS CUI [2,2])
C3463824 (UMLS CUI [3,1])
C1510411 (UMLS CUI [3,2])
C0023467 (UMLS CUI [3,3])
Ineligibility Allograft | Age | Comorbidity
Item
5. ineligibility for standard conditioning allograft due to age or co-existing morbidities
boolean
C1512714 (UMLS CUI [1,1])
C0040739 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
Donor Selection
Item
donor selection
boolean
C1449559 (UMLS CUI [1])
Matched Related Donor HLA-A Molecular Typing | Matched Related Donor HLA-B Molecular Typing | Matched Related Donor HLA-C Molecular Typing | Matched Related Donor HLA-DRB1 Molecular Typing | Matched Related Donor HLA-DQB1 Molecular Typing
Item
1. related donors compatible for hla-a, b, c, drb1 and dqb1 by molecular typing.
boolean
C4330663 (UMLS CUI [1,1])
C0019728 (UMLS CUI [1,2])
C2936546 (UMLS CUI [1,3])
C4330663 (UMLS CUI [2,1])
C0019737 (UMLS CUI [2,2])
C2936546 (UMLS CUI [2,3])
C4330663 (UMLS CUI [3,1])
C0019751 (UMLS CUI [3,2])
C2936546 (UMLS CUI [3,3])
C4330663 (UMLS CUI [4,1])
C0122040 (UMLS CUI [4,2])
C2936546 (UMLS CUI [4,3])
C4330663 (UMLS CUI [5,1])
C0122020 (UMLS CUI [5,2])
C2936546 (UMLS CUI [5,3])
Item Group
C0680251 (UMLS CUI)
Patient Selection
Item
patient selection
boolean
C0242802 (UMLS CUI [1])
Heart failure Treatment required for | Coronary Artery Disease Symptomatic
Item
1. cardiac insufficiency requiring treatment or symptomatic coronary artery disease.
boolean
C0018801 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C1956346 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Liver disease | Aspartate aminotransferase increased
Item
2. hepatic disease, with ast > 2 times normal.
boolean
C0023895 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Hypoxemia Severe | PO2 measurement | Decreased DLCO | Hypoxemia Mild | Decreased DLCO Severely
Item
3. severe hypoxaemia, po2 < 70 mm hg, with decreased dlco < 70% of predicted; or mild hypoxemia, po2 < 80 mm hg with severely decreased dlco < 60% of predicted.
boolean
C0700292 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1283004 (UMLS CUI [2])
C4073175 (UMLS CUI [3])
C0700292 (UMLS CUI [4,1])
C2945599 (UMLS CUI [4,2])
C4073175 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
Renal Insufficiency | Serum creatinine raised | Creatinine clearance measurement | Age | Gender | Body Weight
Item
4. impaired renal function (creatinine > 2 times upper limit of normal or creatinine clearance < 50% for age, gender, weight).
boolean
C1565489 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
C0079399 (UMLS CUI [5])
C0005910 (UMLS CUI [6])
Thymoglobulin
Item
5. patients who have received previous treatment with thymoglobuline
boolean
C0730920 (UMLS CUI [1])
HIV Seropositivity
Item
6. hiv-positive patients.
boolean
C0019699 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
7. female patients who are pregnant or breast feeding due to risks to foetus from conditioning regimen and potential risks to nursing infants.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Life Expectancy Limitation Severe | Etiology Disease | Exception MYELODYSPLASTIC SYNDROME | Exception Myeloproliferative disease
Item
8. life expectancy severely limited by diseases other than mds or mpd.
boolean
C0023671 (UMLS CUI [1,1])
C0449295 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C3463824 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0027022 (UMLS CUI [4,2])
Communicable Disease Serious Untreated
Item
9. serious concurrent untreated infection
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
Life Expectancy Limited Other reasons
Item
10. patients with limited life expectancy for other reasons
boolean
C0023671 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C3845511 (UMLS CUI [1,3])
Serious mental illness
Item
11. serious psychiatric/ psychological disorders
boolean
C3841614 (UMLS CUI [1])
Informed Consent Absent | Informed Consent Unable
Item
12. absence of /inability to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Donor Selection
Item
donor selection
boolean
C1449559 (UMLS CUI [1])
Age | Exception Fit Tissue Donation
Item
1. age >75 years, unless independently assessed to be medically fit to donate
boolean
C0001779 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0424576 (UMLS CUI [2,2])
C0080231 (UMLS CUI [2,3])
Donor Leukapheresis Unable | Donor Anesthesia Unable | Anesthesia Bone marrow harvest
Item
2. donors who for any reason are unable to tolerate the leukapheresis procedure and cannot undergo anaesthesia for marrow harvest.
boolean
C0013018 (UMLS CUI [1,1])
C0023416 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0013018 (UMLS CUI [2,1])
C0002903 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0002903 (UMLS CUI [3,1])
C0194015 (UMLS CUI [3,2])
Donor HIV Seropositivity | Donor Blood hepatitis B virus detection by polymerase chain reaction test | Donor Serum hepatitis C detection by polymerase chain reaction test
Item
3. donors who are hiv-positive, or hepatitis b or c pcr positive.
boolean
C0013018 (UMLS CUI [1,1])
C0019699 (UMLS CUI [1,2])
C0013018 (UMLS CUI [2,1])
C2120948 (UMLS CUI [2,2])
C0013018 (UMLS CUI [3,1])
C2098826 (UMLS CUI [3,2])
Donor Medically unfit Tissue Donation
Item
4. donors who are medically unsuitable to donate
boolean
C0013018 (UMLS CUI [1,1])
C3841806 (UMLS CUI [1,2])
C0080231 (UMLS CUI [1,3])
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