ID

14571

Description

Azacitidine in Treating Patients With Relapsed Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia Who Have Undergone Stem Cell Transplant; ODM derived from: https://clinicaltrials.gov/show/NCT01083706

Link

https://clinicaltrials.gov/show/NCT01083706

Keywords

Versions (1)
  1. 4/21/16 4/21/16 -
Uploaded on

April 21, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities NCT01083706

English

Eligibility Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities NCT01083706

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
mds, cmml or aml patients (as diagnosed by world health organization [who] criteria) with evidence of relapse or progression at >= day 28 and < day 100 post-transplant
Description

mds

Data type

boolean

Alias
UMLS CUI [1]
C3463824
recurrent or increased cytogenetic abnormalities by standard karyotype or fluorescence in situ hybridization (fish) (the cytogenetic abnormalities must have been previously documented at some time point between diagnosis and date of stem cell transplant)
Description

cytogenetic abnormalities

Data type

boolean

Alias
UMLS CUI [1]
C0008625
morphologic evidence of recurrence or increased abnormal myeloblasts in peripheral blood or marrow
Description

Myeloblast

Data type

boolean

Alias
UMLS CUI [1]
C0229633
flow cytometric evidence of disease as determined by recurrent or increased abnormal myeloblasts in peripheral blood or marrow
Description

Myeloblasts flow cytometric

Data type

boolean

Alias
UMLS CUI [1,1]
C0580952
UMLS CUI [1,2]
C0201644
extramedullary relapse (local radiotherapy will be allowed)
Description

extramedullary relapse

Data type

boolean

Alias
UMLS CUI [1]
C2854080
mds, cmml, or aml patients with persistent stable disease or persistent disease with regression at >= day 28 and < day 100 post-transplant; the inclusion of patients with persistent stable or persistent regressing disease in this protocol is not meant to advocate treatment; however, if the attending physician is inclined to offer treatment then these patients would be eligible for this study
Description

mds, cmml, or aml patients

Data type

boolean

Alias
UMLS CUI [1]
C3463824
UMLS CUI [2]
C0023480
persistence of cytogenetic abnormalities by standard karyotype or fish
Description

cytogenetic abnormalities

Data type

boolean

Alias
UMLS CUI [1]
C0008625
persistent morphologic evidence of abnormal myeloblasts (in patients with cmml the monoblastoid population is included) in peripheral blood or marrow
Description

abnormal myeloblasts

Data type

boolean

Alias
UMLS CUI [1,1]
C0205161
UMLS CUI [1,2]
C0229633
extramedullary persistence or regression
Description

Extramedullary

Data type

boolean

Alias
UMLS CUI [1]
C1517060
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
refractory disease at time of stem cell transplant; patients who received chemotherapy prior to transplant with no evidence of response by international working group (iwg) criteria
Description

Refractory Disease

Data type

boolean

Alias
UMLS CUI [1]
C1514815
>= 10% bone marrow myeloblasts as measured by morphology
Description

Bone marrow myeloblasts

Data type

boolean

Alias
UMLS CUI [1]
C1993094
evidence of central nervous system (cns) disease at time of relapse by morphology or flow (a diagnostic lumbar puncture [lp] is not required at time of relapse)
Description

central nervous system

Data type

boolean

Alias
UMLS CUI [1]
C0007684
serum creatinine > 2 x uln (upper limit of normal)
Description

serum creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
aspartate aminotransferase (ast)/ alanine aminotransferase (alt) > 2x uln
Description

aspartate aminotransferase

Data type

boolean

Alias
UMLS CUI [1]
C0201899
performance status > 2 (eastern cooperative oncology group [ecog] scale)
Description

eastern cooperative oncology group

Data type

boolean

Alias
UMLS CUI [1]
C1512162
patients with severe disease other than mds, cmml or aml which would be expected to prevent compliance with treatment
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0009488
patients with severe infections (pneumonia, sepsis, etc) within the 2 weeks prior to the anticipated start of protocol treatment
Description

severe infections

Data type

boolean

Alias
UMLS CUI [1]
C3714514
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Similar models

Eligibility Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities NCT01083706

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
mds
Item
mds, cmml or aml patients (as diagnosed by world health organization [who] criteria) with evidence of relapse or progression at >= day 28 and < day 100 post-transplant
boolean
C3463824 (UMLS CUI [1])
cytogenetic abnormalities
Item
recurrent or increased cytogenetic abnormalities by standard karyotype or fluorescence in situ hybridization (fish) (the cytogenetic abnormalities must have been previously documented at some time point between diagnosis and date of stem cell transplant)
boolean
C0008625 (UMLS CUI [1])
Myeloblast
Item
morphologic evidence of recurrence or increased abnormal myeloblasts in peripheral blood or marrow
boolean
C0229633 (UMLS CUI [1])
Myeloblasts flow cytometric
Item
flow cytometric evidence of disease as determined by recurrent or increased abnormal myeloblasts in peripheral blood or marrow
boolean
C0580952 (UMLS CUI [1,1])
C0201644 (UMLS CUI [1,2])
extramedullary relapse
Item
extramedullary relapse (local radiotherapy will be allowed)
boolean
C2854080 (UMLS CUI [1])
mds, cmml, or aml patients
Item
mds, cmml, or aml patients with persistent stable disease or persistent disease with regression at >= day 28 and < day 100 post-transplant; the inclusion of patients with persistent stable or persistent regressing disease in this protocol is not meant to advocate treatment; however, if the attending physician is inclined to offer treatment then these patients would be eligible for this study
boolean
C3463824 (UMLS CUI [1])
C0023480 (UMLS CUI [2])
cytogenetic abnormalities
Item
persistence of cytogenetic abnormalities by standard karyotype or fish
boolean
C0008625 (UMLS CUI [1])
abnormal myeloblasts
Item
persistent morphologic evidence of abnormal myeloblasts (in patients with cmml the monoblastoid population is included) in peripheral blood or marrow
boolean
C0205161 (UMLS CUI [1,1])
C0229633 (UMLS CUI [1,2])
Extramedullary
Item
extramedullary persistence or regression
boolean
C1517060 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Refractory Disease
Item
refractory disease at time of stem cell transplant; patients who received chemotherapy prior to transplant with no evidence of response by international working group (iwg) criteria
boolean
C1514815 (UMLS CUI [1])
Bone marrow myeloblasts
Item
>= 10% bone marrow myeloblasts as measured by morphology
boolean
C1993094 (UMLS CUI [1])
central nervous system
Item
evidence of central nervous system (cns) disease at time of relapse by morphology or flow (a diagnostic lumbar puncture [lp] is not required at time of relapse)
boolean
C0007684 (UMLS CUI [1])
serum creatinine
Item
serum creatinine > 2 x uln (upper limit of normal)
boolean
C0201976 (UMLS CUI [1])
aspartate aminotransferase
Item
aspartate aminotransferase (ast)/ alanine aminotransferase (alt) > 2x uln
boolean
C0201899 (UMLS CUI [1])
eastern cooperative oncology group
Item
performance status > 2 (eastern cooperative oncology group [ecog] scale)
boolean
C1512162 (UMLS CUI [1])
Protocol Compliance
Item
patients with severe disease other than mds, cmml or aml which would be expected to prevent compliance with treatment
boolean
C0525058 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
severe infections
Item
patients with severe infections (pneumonia, sepsis, etc) within the 2 weeks prior to the anticipated start of protocol treatment
boolean
C3714514 (UMLS CUI [1])
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