ID

30180

Description

Clofarabine and Temsirolimus in Treating Older Patients With Relapsed or Refractory Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00775593

Link

https://clinicaltrials.gov/show/NCT00775593

Keywords

Versions (1)
  1. 5/17/18 5/17/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 17, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT00775593

English

Eligibility Leukemia NCT00775593

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00775593
Criteria
Description

Criteria

cytologically confirmed acute myeloid leukemia (aml) meeting the following criteria:
Description

Leukemia, Myelocytic, Acute

Data type

boolean

Alias
UMLS CUI [1]
C0023467
at least 20% of blasts in the bone marrow
Description

Blasts Bone marrow Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C1982687
UMLS CUI [1,2]
C0439165
aml in first relapse or refractory to no more than one prior combination chemotherapy induction regimen
Description

AML First Relapse | AML refractory | Induction Chemotherapy Combination Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C4054953
UMLS CUI [2,1]
C0023467
UMLS CUI [2,2]
C0205269
UMLS CUI [3,1]
C3179010
UMLS CUI [3,2]
C0205195
UMLS CUI [3,3]
C1265611
no acute promyelocytic leukemia
Description

Exclusion Acute Promyelocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0023487
no blast transformation of chronic myeloid leukemia or other myeloproliferative disorders
Description

Exclusion Criteria | Blast transformation Chronic Myeloid Leukemia | Myeloproliferative disease

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0368761
UMLS CUI [2,2]
C0040682
UMLS CUI [2,3]
C0023473
UMLS CUI [3]
C0027022
no active cns leukemia
Description

Exclusion Central nervous system leukaemia

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C1332884
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
who performance status 0-2
Description

WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1]
C1298650
life expectancy ≥ 4 weeks
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
serum total bilirubin ≤ 1.5 times upper limit of normal (uln)*
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
ast and alt ≤ 2.5 times uln*
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
serum creatinine ≤ 1.0 mg/dl* or estimated glomerular filtration rate > 60 ml/min
Description

Creatinine measurement, serum | Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C3811844
no active uncontrolled systemic infection
Description

Exclusion Sepsis Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0243026
UMLS CUI [1,3]
C0205318
no concurrent active malignancy
Description

Exclusion Cancer Other

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C1707251
no hiv positivity
Description

Exclusion HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0019699
no severe concurrent medical condition or psychiatric disorder that would preclude study participation note: *unless due to organ leukemic involvement
Description

Exclusion Criteria | Other medical condition Severe Study Subject Participation Status Excluded | Mental disorders Severe Study Subject Participation Status Excluded | Exception Organ involvement Leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C2348568
UMLS CUI [2,4]
C0332196
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C2348568
UMLS CUI [3,4]
C0332196
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0457576
UMLS CUI [4,3]
C0023418
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Description

ID.18

Data type

boolean

more than 2 weeks since prior myelosuppressive chemotherapy
Description

Myelosuppressive Chemotherapy Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C1513793
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0205156
at least 48 hours since prior hydroxyurea
Description

Hydroxyurea Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0020402
UMLS CUI [1,2]
C0205156
no prior clofarabine or temsirolimus
Description

Exclusion Criteria | clofarabine | temsirolimus

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0092777
UMLS CUI [3]
C1707080
no prior allogeneic stem cell transplantation
Description

Exclusion Allogeneic Hematopoietic Stem Cell Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C1705576
no investigational drug within the past 30 days
Description

Exclusion Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0013230
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Similar models

Eligibility Leukemia NCT00775593

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00775593
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Leukemia, Myelocytic, Acute
Item
cytologically confirmed acute myeloid leukemia (aml) meeting the following criteria:
boolean
C0023467 (UMLS CUI [1])
Blasts Bone marrow Percentage
Item
at least 20% of blasts in the bone marrow
boolean
C1982687 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
AML First Relapse | AML refractory | Induction Chemotherapy Combination Quantity
Item
aml in first relapse or refractory to no more than one prior combination chemotherapy induction regimen
boolean
C0023467 (UMLS CUI [1,1])
C4054953 (UMLS CUI [1,2])
C0023467 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C3179010 (UMLS CUI [3,1])
C0205195 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Exclusion Acute Promyelocytic Leukemia
Item
no acute promyelocytic leukemia
boolean
C2828389 (UMLS CUI [1,1])
C0023487 (UMLS CUI [1,2])
Exclusion Criteria | Blast transformation Chronic Myeloid Leukemia | Myeloproliferative disease
Item
no blast transformation of chronic myeloid leukemia or other myeloproliferative disorders
boolean
C0680251 (UMLS CUI [1])
C0368761 (UMLS CUI [2,1])
C0040682 (UMLS CUI [2,2])
C0023473 (UMLS CUI [2,3])
C0027022 (UMLS CUI [3])
Exclusion Central nervous system leukaemia
Item
no active cns leukemia
boolean
C2828389 (UMLS CUI [1,1])
C1332884 (UMLS CUI [1,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
WHO performance status scale
Item
who performance status 0-2
boolean
C1298650 (UMLS CUI [1])
Life Expectancy
Item
life expectancy ≥ 4 weeks
boolean
C0023671 (UMLS CUI [1])
Serum total bilirubin measurement
Item
serum total bilirubin ≤ 1.5 times upper limit of normal (uln)*
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast and alt ≤ 2.5 times uln*
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum | Estimated Glomerular Filtration Rate
Item
serum creatinine ≤ 1.0 mg/dl* or estimated glomerular filtration rate > 60 ml/min
boolean
C0201976 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
Exclusion Sepsis Uncontrolled
Item
no active uncontrolled systemic infection
boolean
C2828389 (UMLS CUI [1,1])
C0243026 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Exclusion Cancer Other
Item
no concurrent active malignancy
boolean
C2828389 (UMLS CUI [1,1])
C1707251 (UMLS CUI [1,2])
Exclusion HIV Seropositivity
Item
no hiv positivity
boolean
C2828389 (UMLS CUI [1,1])
C0019699 (UMLS CUI [1,2])
Exclusion Criteria | Other medical condition Severe Study Subject Participation Status Excluded | Mental disorders Severe Study Subject Participation Status Excluded | Exception Organ involvement Leukemia
Item
no severe concurrent medical condition or psychiatric disorder that would preclude study participation note: *unless due to organ leukemic involvement
boolean
C0680251 (UMLS CUI [1])
C3843040 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0332196 (UMLS CUI [2,4])
C0004936 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0332196 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0457576 (UMLS CUI [4,2])
C0023418 (UMLS CUI [4,3])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.18
Item
see disease characteristics
boolean
Myelosuppressive Chemotherapy Previous
Item
more than 2 weeks since prior myelosuppressive chemotherapy
boolean
C1513793 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Hydroxyurea Previous
Item
at least 48 hours since prior hydroxyurea
boolean
C0020402 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Exclusion Criteria | clofarabine | temsirolimus
Item
no prior clofarabine or temsirolimus
boolean
C0680251 (UMLS CUI [1])
C0092777 (UMLS CUI [2])
C1707080 (UMLS CUI [3])
Exclusion Allogeneic Hematopoietic Stem Cell Transplantation
Item
no prior allogeneic stem cell transplantation
boolean
C2828389 (UMLS CUI [1,1])
C1705576 (UMLS CUI [1,2])
Exclusion Investigational New Drugs
Item
no investigational drug within the past 30 days
boolean
C2828389 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
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