ID

13068

Description

SMD_FLAG-IDA_98: FLAG-IDA in Induction Treatment of High Risk Myelodysplastic Syndromes or Secondary Acute Myeloblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00487448

Link

https://clinicaltrials.gov/show/NCT00487448

Keywords

Versions (1)
  1. 1/14/16 1/14/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 14, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Myelodysplastic Syndrome NCT00487448

English

Eligibility Myelodysplastic Syndrome NCT00487448

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age < 75 years
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of myelodysplastic syndrome in order to fab criteria, excluding patients with chronic myeloid leukemia.
Description

myelodysplastic syndrome

Data type

boolean

Alias
UMLS CUI [1]
C3463824
ipi > 1 (high risk or intermedia risk-2) and/or ipe equal or > 3 (high risk o intermedia risk) or secondary acute myeloid leukemia.
Description

IPI

Data type

boolean

Alias
UMLS CUI [1]
C1512894
resolved toxicity for previous treatments received to myelodysplastic syndrome .
Description

toxicity

Data type

boolean

Alias
UMLS CUI [1]
C0600688
myelodysplastic syndrome de novo.
Description

myelodysplastic syndrome de novo.

Data type

boolean

Alias
UMLS CUI [1]
C3463824
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
associated neoplasia.
Description

neoplasia

Data type

boolean

Alias
UMLS CUI [1]
C1882062
chronic disease that can limit the patient follow up protocol (cardiovascular disease, active infection uncontrolled, etc.).
Description

chronic disease that can limit the patient follow up protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
age < 55 years with related donor hla compatible.
Description

age < 55 years with related donor hla compatible

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0019721
use an investigational drug in the 30 previous days.
Description

investigational drug

Data type

boolean

Alias
UMLS CUI [1]
C0013230
previous treatment with chemotherapy agents.
Description

chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
simultaneous treatment during the study with other drugs not allowed in the protocol.
Description

simultaneous treatment

Data type

boolean

Alias
UMLS CUI [1]
C0087111
bilirubin > 2 mg/dl and gpt >2 times the normal value.
Description

bilirubin and gpt

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C1557189
creatinine > 2 mg/dl.
Description

creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
hypersensibility to agents used in the protocol.
Description

hypersensibility

Data type

boolean

Alias
UMLS CUI [1]
C0020517
secondary mds to chemo-radiotherapy .
Description

secondary mds to chemo-radiotherapy .

Data type

boolean

Alias
UMLS CUI [1]
C3463824
hiv positive.
Description

hiv

Data type

boolean

Alias
UMLS CUI [1]
C0019682
chronic myeloblastic leukemia
Description

CML

Data type

boolean

Alias
UMLS CUI [1]
C0023474
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Similar models

Eligibility Myelodysplastic Syndrome NCT00487448

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
age < 75 years
boolean
C0001779 (UMLS CUI [1])
myelodysplastic syndrome
Item
diagnosis of myelodysplastic syndrome in order to fab criteria, excluding patients with chronic myeloid leukemia.
boolean
C3463824 (UMLS CUI [1])
IPI
Item
ipi > 1 (high risk or intermedia risk-2) and/or ipe equal or > 3 (high risk o intermedia risk) or secondary acute myeloid leukemia.
boolean
C1512894 (UMLS CUI [1])
toxicity
Item
resolved toxicity for previous treatments received to myelodysplastic syndrome .
boolean
C0600688 (UMLS CUI [1])
myelodysplastic syndrome de novo.
Item
myelodysplastic syndrome de novo.
boolean
C3463824 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
neoplasia
Item
associated neoplasia.
boolean
C1882062 (UMLS CUI [1])
chronic disease that can limit the patient follow up protocol
Item
chronic disease that can limit the patient follow up protocol (cardiovascular disease, active infection uncontrolled, etc.).
boolean
C2348563 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
age < 55 years with related donor hla compatible
Item
age < 55 years with related donor hla compatible.
boolean
C0001779 (UMLS CUI [1])
C0019721 (UMLS CUI [2])
investigational drug
Item
use an investigational drug in the 30 previous days.
boolean
C0013230 (UMLS CUI [1])
chemotherapy
Item
previous treatment with chemotherapy agents.
boolean
C0392920 (UMLS CUI [1])
simultaneous treatment
Item
simultaneous treatment during the study with other drugs not allowed in the protocol.
boolean
C0087111 (UMLS CUI [1])
bilirubin and gpt
Item
bilirubin > 2 mg/dl and gpt >2 times the normal value.
boolean
C1278039 (UMLS CUI [1])
C1557189 (UMLS CUI [2])
creatinine
Item
creatinine > 2 mg/dl.
boolean
C0201976 (UMLS CUI [1])
hypersensibility
Item
hypersensibility to agents used in the protocol.
boolean
C0020517 (UMLS CUI [1])
secondary mds to chemo-radiotherapy .
Item
secondary mds to chemo-radiotherapy .
boolean
C3463824 (UMLS CUI [1])
hiv
Item
hiv positive.
boolean
C0019682 (UMLS CUI [1])
CML
Item
chronic myeloblastic leukemia
boolean
C0023474 (UMLS CUI [1])
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