ID

12755

Description

Fludarabine, Cytarabine, Topotecan in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00488709

Link

https://clinicaltrials.gov/show/NCT00488709

Keywords

Versions (1)
  1. 12/21/15 12/21/15 -
Uploaded on

December 21, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Acute Myeloid Leukemia NCT00488709

English

Eligibility Acute Myeloid Leukemia NCT00488709

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subjects of 18 years of age or major, with diagnosis of primary or secondary aml, confirmed cytologically, that fulfill one of the following conditions:
Description

age; AML

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0023467
do not reach a cr after the conventional treatment.
Description

complete remission; conventional treatment

Data type

boolean

Alias
UMLS CUI [1]
C0677874
UMLS CUI [2]
C2945704
relapse in the first 12 months after a cr. during remission, patients can have be treated by a transplant. the relapse is defined as the presence of blasts in peripheric blood or the presence of >5 % of blasts in mo.
Description

relapse

Data type

boolean

Alias
UMLS CUI [1]
C0035020
not participation in a clinical trial.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
2. ecog < o = 2
Description

ecog

Data type

boolean

Alias
UMLS CUI [1]
C1520224
3. considered suitable patients for an intensive chemotherapy
Description

Chemotherapy Intensive

Data type

boolean

Alias
UMLS CUI [1,1]
C3665472
UMLS CUI [1,2]
C2827726
4. informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pelvic or spinal radiotherapy in 4 weeks before the incorporation in the protocol.
Description

radiotherapy Pelvis; radiotherapy spinal

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0030797
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0521329
2. acute promyelocytic leukaemia
Description

acute promyelocytic leukaemia

Data type

boolean

Alias
UMLS CUI [1]
C0023487
3. first line chemotherapy for aml which has contained fludarabine or topotecan.
Description

chemotherapy fludarabine; chemotherapy Topotecan

Data type

boolean

Alias
UMLS CUI [1,1]
C3665472
UMLS CUI [1,2]
C0059985
UMLS CUI [2,1]
C3665472
UMLS CUI [2,2]
C0146224
4. active or chronic hepatitis or hepatic cirrhosis.
Description

Hepatitis, Chronic; Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0019189
UMLS CUI [2]
C0023890
5. positivity known to the virus of the human immunodeficiency (hiv)
Description

HIV positve

Data type

boolean

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C1446409
6. pregnant or breastfeeding patients.
Description

pregnant; Lactating

Data type

boolean

Alias
UMLS CUI [1,1]
C2828358
UMLS CUI [1,2]
C0549206
7. patients with deterioration of the functions hepatic or renal, defined for the following values base them of laboratory:
Description

Hepatic Insufficiency; Renal Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C1306571
UMLS CUI [2]
C1565489
ast or alt >2,5 times the top limit of the normality of the center (lsnc)
Description

Aspartate aminotransferase measurement; Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
alkaline phosphatase >2,5 times the lsnc
Description

alkaline phosphatase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201850
total bilirubin value >2 times the lsnc
Description

Bilirubin, total measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201913
creatinine value >2 times the lsnc after a suitable hydration
Description

Creatinine measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201975
8. precedents of intervention of major surgery in 2 weeks before the incorporation in the protocol.
Description

major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
9. patients with disease serious or not controlled (for example not controlled diabetes, infection, hypertension, etc.).
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
10. patients who have received other cytotoxic drugs (except hydroxyurea to reduce the leucocytosis) as treatment of the current relapse or of the resistance, in 4 weeks before the protocol.
Description

cytotoxic drugs; hydroxyurea Except for

Data type

boolean

Alias
UMLS CUI [1]
C0304497
UMLS CUI [2,1]
C0020402
UMLS CUI [2,2]
C0332300
11. patients with hypersensitivity known to someone of the drugs of the protocol.
Description

hypersensitivity

Data type

boolean

Alias
UMLS CUI [1]
C0020517
12. patients treated previously with growth factors with purposes of sensibilization.
Description

growth factors therapy; sensibilization

Data type

boolean

Alias
UMLS CUI [1,1]
C0018284
UMLS CUI [1,2]
C0087111
UMLS CUI [2]
C0020971
13. patients with psychological, intellectual or sensitive dysfunction that can reduce his capacity of comprehension and fulfillment of the protocol.
Description

Compliance behavior Limited Comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
14. patients treated before with flat.
Description

Fludarabine, Cytarabine and Topotecan therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0796415
UMLS CUI [1,2]
C0087111
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Similar models

Eligibility Acute Myeloid Leukemia NCT00488709

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age; AML
Item
1. subjects of 18 years of age or major, with diagnosis of primary or secondary aml, confirmed cytologically, that fulfill one of the following conditions:
boolean
C0001779 (UMLS CUI [1])
C0023467 (UMLS CUI [2])
complete remission; conventional treatment
Item
do not reach a cr after the conventional treatment.
boolean
C0677874 (UMLS CUI [1])
C2945704 (UMLS CUI [2])
relapse
Item
relapse in the first 12 months after a cr. during remission, patients can have be treated by a transplant. the relapse is defined as the presence of blasts in peripheric blood or the presence of >5 % of blasts in mo.
boolean
C0035020 (UMLS CUI [1])
Study Subject Participation Status
Item
not participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
ecog
Item
2. ecog < o = 2
boolean
C1520224 (UMLS CUI [1])
Chemotherapy Intensive
Item
3. considered suitable patients for an intensive chemotherapy
boolean
C3665472 (UMLS CUI [1,1])
C2827726 (UMLS CUI [1,2])
informed consent
Item
4. informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
radiotherapy Pelvis; radiotherapy spinal
Item
1. pelvic or spinal radiotherapy in 4 weeks before the incorporation in the protocol.
boolean
C1522449 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0521329 (UMLS CUI [2,2])
acute promyelocytic leukaemia
Item
2. acute promyelocytic leukaemia
boolean
C0023487 (UMLS CUI [1])
chemotherapy fludarabine; chemotherapy Topotecan
Item
3. first line chemotherapy for aml which has contained fludarabine or topotecan.
boolean
C3665472 (UMLS CUI [1,1])
C0059985 (UMLS CUI [1,2])
C3665472 (UMLS CUI [2,1])
C0146224 (UMLS CUI [2,2])
Hepatitis, Chronic; Liver Cirrhosis
Item
4. active or chronic hepatitis or hepatic cirrhosis.
boolean
C0019189 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
HIV positve
Item
5. positivity known to the virus of the human immunodeficiency (hiv)
boolean
C0019682 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
pregnant; Lactating
Item
6. pregnant or breastfeeding patients.
boolean
C2828358 (UMLS CUI [1,1])
C0549206 (UMLS CUI [1,2])
Hepatic Insufficiency; Renal Insufficiency
Item
7. patients with deterioration of the functions hepatic or renal, defined for the following values base them of laboratory:
boolean
C1306571 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
Aspartate aminotransferase measurement; Alanine aminotransferase measurement
Item
ast or alt >2,5 times the top limit of the normality of the center (lsnc)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
alkaline phosphatase measurement
Item
alkaline phosphatase >2,5 times the lsnc
boolean
C0201850 (UMLS CUI [1])
Bilirubin, total measurement
Item
total bilirubin value >2 times the lsnc
boolean
C0201913 (UMLS CUI [1])
Creatinine measurement
Item
creatinine value >2 times the lsnc after a suitable hydration
boolean
C0201975 (UMLS CUI [1])
major surgery
Item
8. precedents of intervention of major surgery in 2 weeks before the incorporation in the protocol.
boolean
C0679637 (UMLS CUI [1])
comorbidity
Item
9. patients with disease serious or not controlled (for example not controlled diabetes, infection, hypertension, etc.).
boolean
C0009488 (UMLS CUI [1])
cytotoxic drugs; hydroxyurea Except for
Item
10. patients who have received other cytotoxic drugs (except hydroxyurea to reduce the leucocytosis) as treatment of the current relapse or of the resistance, in 4 weeks before the protocol.
boolean
C0304497 (UMLS CUI [1])
C0020402 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
hypersensitivity
Item
11. patients with hypersensitivity known to someone of the drugs of the protocol.
boolean
C0020517 (UMLS CUI [1])
growth factors therapy; sensibilization
Item
12. patients treated previously with growth factors with purposes of sensibilization.
boolean
C0018284 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0020971 (UMLS CUI [2])
Compliance behavior Limited Comorbidity
Item
13. patients with psychological, intellectual or sensitive dysfunction that can reduce his capacity of comprehension and fulfillment of the protocol.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Fludarabine, Cytarabine and Topotecan therapy
Item
14. patients treated before with flat.
boolean
C0796415 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
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