ID

14382

Beschreibung

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

Stichworte

Versionen (1)
  1. 12.04.16 12.04.16 -
Hochgeladen am

12. April 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Leukemia NCT00609739

Englisch

Eligibility Leukemia NCT00609739

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00609739
Inclusion Criteria
Beschreibung

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.
Beschreibung

Patient and disease status

Datentyp

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).
Beschreibung

Hematopoietic cell transplant: date of procedure

Datentyp

boolean

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

Organ function

Datentyp

boolean

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

Ejection fraction

Datentyp

boolean

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

Fev and dlco

Datentyp

boolean

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

Creatinine clearance

Datentyp

boolean

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

Liver function

Datentyp

boolean

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

Performance status

Datentyp

boolean

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

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Infection: date of diagnosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C2316983
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Ähnliche Modelle

Eligibility Leukemia NCT00609739

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00609739
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

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