ID

28085

Beskrivning

Fludarabine, Busulfan, and Antilymphocyte Globulin Followed by Donor Stem Cell Transplant in Treating Older Patients With Hematological Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00806767

Länk

https://clinicaltrials.gov/show/NCT00806767

Nyckelord

Versioner (1)
  1. 2017-12-16 2017-12-16 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

16 december 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Chronic Myeloproliferative Disorders NCT00806767

Engelsk

Eligibility Chronic Myeloproliferative Disorders NCT00806767

1 Formulär  
Criteria
Beskrivning

Criteria

diagnosis of a hematological malignancy
Beskrivning

Hematologic Neoplasm

Datatyp

boolean

Alias
UMLS CUI [1]
C0376545
candidate for an allogeneic hematopoietic stem cell transplantation
Beskrivning

Allogeneic Hematopoietic Stem Cell Transplantation Scheduled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1705576
UMLS CUI [1,2]
C0205539
available hla-identical related donor
Beskrivning

Donor Relative HLA Antigens Match Available

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040288
UMLS CUI [1,2]
C0080103
UMLS CUI [1,3]
C0019721
UMLS CUI [1,4]
C1708943
UMLS CUI [1,5]
C0470187
patient characteristics:
Beskrivning

Client Characteristics

Datatyp

boolean

Alias
UMLS CUI [1]
C0815172
who performance status (ps) 0-1 or karnofsky ps 70-100%
Beskrivning

WHO performance status scale | Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C1298650
UMLS CUI [2]
C0206065
life expectancy > 6 months
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
lvef ≥ 40%
Beskrivning

Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
dlco ≥ 50%
Beskrivning

Carbon Monoxide Diffusing Capability Test

Datatyp

boolean

Alias
UMLS CUI [1]
C1516251
creatinine clearance ≥ 30 ml/min
Beskrivning

Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0373595
transaminases and/or bilirubin ≤ 2 times upper limit of normal (uln)
Beskrivning

Transaminases | Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0002594
UMLS CUI [2]
C1278039
no other cancer within the past 5 years, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix
Beskrivning

Exclusion Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
no human t-cell leukemia virus type 1 positivity
Beskrivning

Exclusion | Human t-cell leukemia virus 1 Positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0020094
UMLS CUI [1,3]
C1514241
no hiv positivity
Beskrivning

Exclusion HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0019699
no uncontrolled bacterial, viral, or fungal infection
Beskrivning

Exclusion Criteria | Bacterial Infection Uncontrolled | Virus Disease Uncontrolled | Mycoses Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0004623
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0042769
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0026946
UMLS CUI [4,2]
C0205318
no contraindications to the study drugs
Beskrivning

Exclusion | Medical contraindication Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0013230
no concurrent serious and uncontrolled disease
Beskrivning

Exclusion | Comorbidity Serious Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0205318
prior concurrent therapy:
Beskrivning

Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0087111
at least 1 month since prior participation in a clinical trial
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Chronic Myeloproliferative Disorders NCT00806767

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Hematologic Neoplasm
Item
diagnosis of a hematological malignancy
boolean
C0376545 (UMLS CUI [1])
Allogeneic Hematopoietic Stem Cell Transplantation Scheduled
Item
candidate for an allogeneic hematopoietic stem cell transplantation
boolean
C1705576 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
Donor Relative HLA Antigens Match Available
Item
available hla-identical related donor
boolean
C0040288 (UMLS CUI [1,1])
C0080103 (UMLS CUI [1,2])
C0019721 (UMLS CUI [1,3])
C1708943 (UMLS CUI [1,4])
C0470187 (UMLS CUI [1,5])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
WHO performance status scale | Karnofsky Performance Status
Item
who performance status (ps) 0-1 or karnofsky ps 70-100%
boolean
C1298650 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Life Expectancy
Item
life expectancy > 6 months
boolean
C0023671 (UMLS CUI [1])
Left ventricular ejection fraction
Item
lvef ≥ 40%
boolean
C0428772 (UMLS CUI [1])
Carbon Monoxide Diffusing Capability Test
Item
dlco ≥ 50%
boolean
C1516251 (UMLS CUI [1])
Creatinine clearance measurement
Item
creatinine clearance ≥ 30 ml/min
boolean
C0373595 (UMLS CUI [1])
Transaminases | Serum total bilirubin measurement
Item
transaminases and/or bilirubin ≤ 2 times upper limit of normal (uln)
boolean
C0002594 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
Exclusion Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
no other cancer within the past 5 years, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix
boolean
C2828389 (UMLS CUI [1,1])
C1707251 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Exclusion | Human t-cell leukemia virus 1 Positive
Item
no human t-cell leukemia virus type 1 positivity
boolean
C2828389 (UMLS CUI [1,1])
C0020094 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
Exclusion HIV Seropositivity
Item
no hiv positivity
boolean
C2828389 (UMLS CUI [1,1])
C0019699 (UMLS CUI [1,2])
Exclusion Criteria | Bacterial Infection Uncontrolled | Virus Disease Uncontrolled | Mycoses Uncontrolled
Item
no uncontrolled bacterial, viral, or fungal infection
boolean
C0680251 (UMLS CUI [1])
C0004623 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0042769 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0026946 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Exclusion | Medical contraindication Investigational New Drugs
Item
no contraindications to the study drugs
boolean
C2828389 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Exclusion | Comorbidity Serious Uncontrolled
Item
no concurrent serious and uncontrolled disease
boolean
C2828389 (UMLS CUI [1])
C0009488 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Study Subject Participation Status
Item
at least 1 month since prior participation in a clinical trial
boolean
C2348568 (UMLS CUI [1])
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