ID

12641

Description

A Study of Withdrawal of Immunosuppression and Donor Lymphocyte Infusions Following Allogeneic Transplant for Pediatric Hematologic Malignancies; ODM derived from: https://clinicaltrials.gov/show/NCT01036009

Link

https://clinicaltrials.gov/show/NCT01036009

Keywords

  1. 12/7/15 12/7/15 -
Uploaded on

December 7, 2015

DOI

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License

Creative Commons BY 4.0

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Eligibility Acute Leukemia NCT01036009

Eligibility Acute Leukemia NCT01036009

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 6 months - 25 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diagnoses of acute leukemia (aml, all, biphenotypic leukemia), pre-leukemic syndromes (monosomy 7 or other bone marrow clonal malformations), jmml, myelodysplastic syndromes or cml.
Description

diagnoses of acute leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0023418
undergoing an allogeneic transplant as standard care.
Description

undergoing an allogeneic transplant as standard care

Data type

boolean

Alias
UMLS CUI [1]
C0149615
performance status: karnofsky/lansky>60%.
Description

performance status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
availability of pre-transplant recipient's dna and donor's dna for chimerism testing. this could be dna or material from which dna could be extracted. frozen blood would be preferred. for some patients, post transplant specimens that are not infiltrated with donor cells may be used.
Description

chimerism testing

Data type

boolean

Alias
UMLS CUI [1]
C3250865
bone marrow or pbmtc as stem cell source.hla matching: donor and recipient should be matched at a minimum of 7/8 antigens (a,b,c and drb1) for bone marrow and pbmtc transplants.
Description

bone marrow or pbmtc as stem cell source.hla matching: donor and recipient should be matched at a minimum of 7/8 antigens (a,b,c and drb1) for bone marrow and pbmtc transplants

Data type

boolean

Alias
UMLS CUI [1]
C0005953
UMLS CUI [2]
C0038250
no history of ≥grade iii acute gvhd.
Description

no history of ≥grade iii acute gvhd

Data type

boolean

Alias
UMLS CUI [1]
C0856825
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment on other experimental protocols, if withdrawal of immunosuppression interferes with procedures of follow-up on the primary study.
Description

study subject participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
leukemia relapse defined as > 5 percent blasts on bone marrow exam or >1 percent leukemia cells by immunoflow mrd, or presence of extramedullary leukemia.
Description

leukemia relapse

Data type

boolean

Alias
UMLS CUI [1]
C0920028
history of acute gvhd ≥ stage iii or with any degree of active acute or cgvhd.
Description

acute gvhd

Data type

boolean

Alias
UMLS CUI [1]
C0856825
on steroids for any reason.
Description

steroid treatment

Data type

boolean

Alias
UMLS CUI [1]
C0149783
any condition that compromises compliance with the objectives and procedures of this protocol, as judged by the principal investigator.
Description

any condition that compromises compliance with the objectives and procedures of this protocol, as judged by the principal investigator.

Data type

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
cells for dli cannot be obtained from the donor.
Description

cells for dli cannot be obtained from the donor

Data type

boolean

Alias
UMLS CUI [1]
C1142167

Similar models

Eligibility Acute Leukemia NCT01036009

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 6 months - 25 years.
boolean
C0001779 (UMLS CUI [1])
diagnoses of acute leukemia
Item
diagnoses of acute leukemia (aml, all, biphenotypic leukemia), pre-leukemic syndromes (monosomy 7 or other bone marrow clonal malformations), jmml, myelodysplastic syndromes or cml.
boolean
C0023418 (UMLS CUI [1])
undergoing an allogeneic transplant as standard care
Item
undergoing an allogeneic transplant as standard care.
boolean
C0149615 (UMLS CUI [1])
performance status
Item
performance status: karnofsky/lansky>60%.
boolean
C0206065 (UMLS CUI [1])
chimerism testing
Item
availability of pre-transplant recipient's dna and donor's dna for chimerism testing. this could be dna or material from which dna could be extracted. frozen blood would be preferred. for some patients, post transplant specimens that are not infiltrated with donor cells may be used.
boolean
C3250865 (UMLS CUI [1])
bone marrow or pbmtc as stem cell source.hla matching: donor and recipient should be matched at a minimum of 7/8 antigens (a,b,c and drb1) for bone marrow and pbmtc transplants
Item
bone marrow or pbmtc as stem cell source.hla matching: donor and recipient should be matched at a minimum of 7/8 antigens (a,b,c and drb1) for bone marrow and pbmtc transplants.
boolean
C0005953 (UMLS CUI [1])
C0038250 (UMLS CUI [2])
no history of ≥grade iii acute gvhd
Item
no history of ≥grade iii acute gvhd.
boolean
C0856825 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
study subject participation status
Item
treatment on other experimental protocols, if withdrawal of immunosuppression interferes with procedures of follow-up on the primary study.
boolean
C2348568 (UMLS CUI [1])
leukemia relapse
Item
leukemia relapse defined as > 5 percent blasts on bone marrow exam or >1 percent leukemia cells by immunoflow mrd, or presence of extramedullary leukemia.
boolean
C0920028 (UMLS CUI [1])
acute gvhd
Item
history of acute gvhd ≥ stage iii or with any degree of active acute or cgvhd.
boolean
C0856825 (UMLS CUI [1])
steroid treatment
Item
on steroids for any reason.
boolean
C0149783 (UMLS CUI [1])
any condition that compromises compliance with the objectives and procedures of this protocol, as judged by the principal investigator.
Item
any condition that compromises compliance with the objectives and procedures of this protocol, as judged by the principal investigator.
boolean
C1321605 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
cells for dli cannot be obtained from the donor
Item
cells for dli cannot be obtained from the donor.
boolean
C1142167 (UMLS CUI [1])

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