ID

14382

Description

Cytosine Arabinoside and Mitoxantrone for Patients With Juvenile Myelomonocytic Leukemia Receiving Repeat Stem Cell Transplantation; ODM derived from: https://clinicaltrials.gov/show/NCT00609739

Link

https://clinicaltrials.gov/show/NCT00609739

Keywords

Versions (1)
  1. 4/12/16 4/12/16 -
Uploaded on

April 12, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT00609739

English

Eligibility Leukemia NCT00609739

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00609739
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients age 0-18 with juvenile myelomonocytic leukemia (jmml) who have relapsed or have residual disease after allogeneic hct. residual disease is defined as failure to eradicate original disease without prior documentation of remission. relapse is defined as reappearance of i) leukocytosis with absolute monocytosis >1 x 10^8/l, ii) presence of immature myeloid cells in the peripheral circulation in two consecutive bone marrow specimens taken at least one month apart, or iii) presence of clonal cytogenetic abnormality. the diagnosis of relapse will be supported by the return of an abnormal cytogenetic marker (if present at diagnosis) or the presence of host cells by rflp or other method.
Description

Patient and disease status

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0349639
UMLS CUI [3]
C1704632
UMLS CUI [4]
C2242529
UMLS CUI [5]
C0023508
UMLS CUI [6]
C0200637
UMLS CUI [7]
C3826992
UMLS CUI [8,1]
C1704387
UMLS CUI [8,2]
C0010802
UMLS CUI [9]
C0035268
patients should be at least 6 months from first hematopoietic cell transplant (hct) if clinically stable. (if jmml is rapidly progressive, second hct may be performed earlier).
Description

Hematopoietic cell transplant: date of procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0472699
UMLS CUI [1,2]
C2584899
adequate major organ function including:
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
cardiac: ejection fraction ≥45%
Description

Ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0232174
pulmonary: fev >50%, dlco >50%
Description

Fev and dlco

Data type

boolean

Alias
UMLS CUI [1]
C0748133
UMLS CUI [2]
C1516251
renal: creatinine clearance ≥40 ml/min
Description

Creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C0373595
hepatic: no clinical evidence of hepatic failure (e.g. coagulopathy, ascites)
Description

Liver function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
karnofsky performance status ≥70% or lansky score ≥50%
Description

Performance status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C1522275
written informed consent.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
active uncontrolled infection within one week of hct.
Description

Infection: date of diagnosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C2316983
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Similar models

Eligibility Leukemia NCT00609739

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00609739
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Patient and disease status
Item
patients age 0-18 with juvenile myelomonocytic leukemia (jmml) who have relapsed or have residual disease after allogeneic hct. residual disease is defined as failure to eradicate original disease without prior documentation of remission. relapse is defined as reappearance of i) leukocytosis with absolute monocytosis >1 x 10^8/l, ii) presence of immature myeloid cells in the peripheral circulation in two consecutive bone marrow specimens taken at least one month apart, or iii) presence of clonal cytogenetic abnormality. the diagnosis of relapse will be supported by the return of an abnormal cytogenetic marker (if present at diagnosis) or the presence of host cells by rflp or other method.
boolean
C0001779 (UMLS CUI [1])
C0349639 (UMLS CUI [2])
C1704632 (UMLS CUI [3])
C2242529 (UMLS CUI [4])
C0023508 (UMLS CUI [5])
C0200637 (UMLS CUI [6])
C3826992 (UMLS CUI [7])
C1704387 (UMLS CUI [8,1])
C0010802 (UMLS CUI [8,2])
C0035268 (UMLS CUI [9])
Hematopoietic cell transplant: date of procedure
Item
patients should be at least 6 months from first hematopoietic cell transplant (hct) if clinically stable. (if jmml is rapidly progressive, second hct may be performed earlier).
boolean
C0472699 (UMLS CUI [1,1])
C2584899 (UMLS CUI [1,2])
Organ function
Item
adequate major organ function including:
boolean
C0678852 (UMLS CUI [1])
Ejection fraction
Item
cardiac: ejection fraction ≥45%
boolean
C0232174 (UMLS CUI [1])
Fev and dlco
Item
pulmonary: fev >50%, dlco >50%
boolean
C0748133 (UMLS CUI [1])
C1516251 (UMLS CUI [2])
Creatinine clearance
Item
renal: creatinine clearance ≥40 ml/min
boolean
C0373595 (UMLS CUI [1])
Liver function
Item
hepatic: no clinical evidence of hepatic failure (e.g. coagulopathy, ascites)
boolean
C0232741 (UMLS CUI [1])
Performance status
Item
karnofsky performance status ≥70% or lansky score ≥50%
boolean
C0206065 (UMLS CUI [1])
C1522275 (UMLS CUI [2])
Informed consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Infection: date of diagnosis
Item
active uncontrolled infection within one week of hct.
boolean
C0009450 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
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