ID

36263

Beschreibung

IFN-DLI for Relapsed Acute Leukemia After Allo-SCT; ODM derived from: https://clinicaltrials.gov/show/NCT02331706

Link

https://clinicaltrials.gov/show/NCT02331706

Stichworte

Versionen (1)
  1. 25.04.19 25.04.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

25. April 2019

DOI

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Creative Commons BY 4.0
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Eligibility Leukemia NCT02331706

Englisch

Eligibility Leukemia NCT02331706

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02331706
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
relapsed aml or all ≥ 60 days after allogeneic sct.
Beschreibung

Acute myeloid leukaemia recurrent | Acute lymphocytic leukemia recurrent | Status post Allogeneic Stem Cell Transplantation

Datentyp

boolean

Alias
UMLS CUI [1]
C1142169
UMLS CUI [2]
C1504403
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C2242529
evidence of residual donor chimerism on most recent analysis (within 4 weeks of enrollment).
Beschreibung

Donor Chimerism Residual Analysis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040288
UMLS CUI [1,2]
C0333678
UMLS CUI [1,3]
C1609982
UMLS CUI [1,4]
C3250864
age ≥ 18 years of age,
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
karnofsky performance status ≥ 60%.
Beschreibung

Karnofsky Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
absence of active gvhd and off immunosuppression. subjects on tapering prednisone will be eligible if their dose is 0.25 mg/kg or less and being actively tapered. we suggest a 28 day waiting period off of immunosuppression but some subjects with rapidly progressive disease may need to be treated before 30 days and will still be eligible.
Beschreibung

Graft-vs-Host Disease Absent | Therapeutic immunosuppression Absent | Prednisone Dose U/day

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018133
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0021079
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0032952
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0456683
adequate organ function: cr ≤ 2 mg/dl; alt/ast < 3 uln, direct bili <3x uln.
Beschreibung

Organ function | Creatinine measurement, serum | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Bilirubin, direct measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201916
matched sibling or un-related donor (a, b, c, and dr) available to undergo leukopheresis.
Beschreibung

Sibling HLA Match | Matched Unrelated Donor | HLA-A Antigens | HLA-B Antigens | HLA-C Antigens | HLA-DR Antigens | Leukapheresis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037047
UMLS CUI [1,2]
C4330149
UMLS CUI [2]
C4318937
UMLS CUI [3]
C0019728
UMLS CUI [4]
C0019737
UMLS CUI [5]
C0019751
UMLS CUI [6]
C0019764
UMLS CUI [7]
C0023416
subjects must be able to sign consent and be willing and able to comply with scheduled visits, treatment plan and laboratory testing.
Beschreibung

Informed Consent | Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
willing to provide blood samples for research purposes.
Beschreibung

Collection of blood specimen for laboratory procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0005834
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior cell therapy for relapse.
Beschreibung

Cell Therapy Recurrent disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0302189
UMLS CUI [1,2]
C0277556
requirement for active immunosuppression to treat gvhd.
Beschreibung

Therapeutic immunosuppression Graft-vs-Host Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021079
UMLS CUI [1,2]
C0018133
pregnant or lactating women. the safety of this therapy on unborn children and effects on breast milk are not known.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
uncontrolled active infection
Beschreibung

Communicable Disease Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
any uncontrolled active medical disorder that would preclude participation as outlined.
Beschreibung

Disease Uncontrolled | Study Subject Participation Status Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0332196
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Ähnliche Modelle

Eligibility Leukemia NCT02331706

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02331706
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Acute myeloid leukaemia recurrent | Acute lymphocytic leukemia recurrent | Status post Allogeneic Stem Cell Transplantation
Item
relapsed aml or all ≥ 60 days after allogeneic sct.
boolean
C1142169 (UMLS CUI [1])
C1504403 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C2242529 (UMLS CUI [3,2])
Donor Chimerism Residual Analysis
Item
evidence of residual donor chimerism on most recent analysis (within 4 weeks of enrollment).
boolean
C0040288 (UMLS CUI [1,1])
C0333678 (UMLS CUI [1,2])
C1609982 (UMLS CUI [1,3])
C3250864 (UMLS CUI [1,4])
Age
Item
age ≥ 18 years of age,
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky performance status ≥ 60%.
boolean
C0206065 (UMLS CUI [1])
Graft-vs-Host Disease Absent | Therapeutic immunosuppression Absent | Prednisone Dose U/day
Item
absence of active gvhd and off immunosuppression. subjects on tapering prednisone will be eligible if their dose is 0.25 mg/kg or less and being actively tapered. we suggest a 28 day waiting period off of immunosuppression but some subjects with rapidly progressive disease may need to be treated before 30 days and will still be eligible.
boolean
C0018133 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0021079 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0032952 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0456683 (UMLS CUI [3,3])
Organ function | Creatinine measurement, serum | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Bilirubin, direct measurement
Item
adequate organ function: cr ≤ 2 mg/dl; alt/ast < 3 uln, direct bili <3x uln.
boolean
C0678852 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201916 (UMLS CUI [5])
Sibling HLA Match | Matched Unrelated Donor | HLA-A Antigens | HLA-B Antigens | HLA-C Antigens | HLA-DR Antigens | Leukapheresis
Item
matched sibling or un-related donor (a, b, c, and dr) available to undergo leukopheresis.
boolean
C0037047 (UMLS CUI [1,1])
C4330149 (UMLS CUI [1,2])
C4318937 (UMLS CUI [2])
C0019728 (UMLS CUI [3])
C0019737 (UMLS CUI [4])
C0019751 (UMLS CUI [5])
C0019764 (UMLS CUI [6])
C0023416 (UMLS CUI [7])
Informed Consent | Protocol Compliance
Item
subjects must be able to sign consent and be willing and able to comply with scheduled visits, treatment plan and laboratory testing.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Collection of blood specimen for laboratory procedure
Item
willing to provide blood samples for research purposes.
boolean
C0005834 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cell Therapy Recurrent disease
Item
prior cell therapy for relapse.
boolean
C0302189 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
Therapeutic immunosuppression Graft-vs-Host Disease
Item
requirement for active immunosuppression to treat gvhd.
boolean
C0021079 (UMLS CUI [1,1])
C0018133 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women. the safety of this therapy on unborn children and effects on breast milk are not known.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Communicable Disease Uncontrolled
Item
uncontrolled active infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Disease Uncontrolled | Study Subject Participation Status Excluded
Item
any uncontrolled active medical disorder that would preclude participation as outlined.
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
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