ID

13723

Description

A Study of Decitabine in Combination With Escalating Doses of Rapamycin in Patients With Relapsed or Refractory Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00861874

Link

https://clinicaltrials.gov/show/NCT00861874

Keywords

Versions (1)
  1. 3/1/16 3/1/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

March 1, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT00861874

English

Eligibility Acute Myeloid Leukemia NCT00861874

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age greater than or equal to 18 years
Description

age greater than or equal to 18 years

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of aml according to who criteria except acute promyelocytic leukemia and
Description

diagnosis of aml according to who criteria except acute promyelocytic leukemia and

Data type

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C0023487
refractory aml defined as a failure to achieve cr after 2 cycles of induction chemotherapy or persistence of > 40% bone marrow blasts after one cycle of chemotherapy induction or
Description

refractory aml defined as a failure to achieve cr after 2 cycles of induction chemotherapy or persistence of > 40% bone marrow blasts after one cycle of chemotherapy induction or

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0205269
UMLS CUI [2]
C1982687
relapsed aml defined as any evidence of disease recurrence within 12 months of achieving first cr or
Description

relapsed aml defined as any evidence of disease recurrence within 12 months of achieving first cr or

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0277556
relapsed aml after stem cell transplantation 100 days must have elapsed between transplant and emergence of recurrent aml
Description

relapsed aml after stem cell transplantation 100 days must have elapsed between transplant and emergence of recurrent aml

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0277556
UMLS CUI [2]
C1504389
ecog performance status <3 (appendix 1)
Description

ecog performance status <3 (appendix 1)

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
abnormal renal function as evidenced by a calculated creatinine clearance ≤ 30ml/min (cockcroft-gault formula (appendix 2)
Description

abnormal renal function as evidenced by a calculated creatinine clearance ≤ 30ml/min (cockcroft-gault formula (appendix 2)

Data type

boolean

Alias
UMLS CUI [1]
C0373595
abnormal liver function: bilirubin >2.0 mg/dl, transaminase more than 2.5x the upper limits of normal
Description

abnormal liver function: bilirubin >2.0 mg/dl, transaminase more than 2.5x the upper limits of normal

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0002594
active systemic infection
Description

active systemic infection

Data type

boolean

Alias
UMLS CUI [1]
C0009488
known chronic liver disease
Description

known chronic liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0341439
known diagnosis of human immunodeficiency virus infection (hiv)
Description

known diagnosis of human immunodeficiency virus infection (hiv)

Data type

boolean

Alias
UMLS CUI [1]
C0019682
patients who are post-allogeneic transplantation should not have active gvhd greater than grade 1 of skin
Description

patients who are post-allogeneic transplantation should not have active gvhd greater than grade 1 of skin

Data type

boolean

Alias
UMLS CUI [1,1]
C0018133
UMLS CUI [1,2]
C1123023
pregnant or breast feeding female subjects
Description

pregnant or breast feeding female subjects

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Acute Myeloid Leukemia NCT00861874

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
age greater than or equal to 18 years
boolean
C0001779 (UMLS CUI [1])
AML except APL
Item
diagnosis of aml according to who criteria except acute promyelocytic leukemia and
boolean
C0023467 (UMLS CUI [1])
C0023487 (UMLS CUI [2])
refractory aml
Item
refractory aml defined as a failure to achieve cr after 2 cycles of induction chemotherapy or persistence of > 40% bone marrow blasts after one cycle of chemotherapy induction or
boolean
C0023467 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C1982687 (UMLS CUI [2])
relapsed aml
Item
relapsed aml defined as any evidence of disease recurrence within 12 months of achieving first cr or
boolean
C0023467 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
relapsed aml after stem cell transplantation
Item
relapsed aml after stem cell transplantation 100 days must have elapsed between transplant and emergence of recurrent aml
boolean
C0023467 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
C1504389 (UMLS CUI [2])
ECOG
Item
ecog performance status <3 (appendix 1)
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
renal function
Item
abnormal renal function as evidenced by a calculated creatinine clearance ≤ 30ml/min (cockcroft-gault formula (appendix 2)
boolean
C0373595 (UMLS CUI [1])
liver function
Item
abnormal liver function: bilirubin >2.0 mg/dl, transaminase more than 2.5x the upper limits of normal
boolean
C1278039 (UMLS CUI [1])
C0002594 (UMLS CUI [2])
active systemic infection
Item
active systemic infection
boolean
C0009488 (UMLS CUI [1])
chronic liver disease
Item
known chronic liver disease
boolean
C0341439 (UMLS CUI [1])
hiv
Item
known diagnosis of human immunodeficiency virus infection (hiv)
boolean
C0019682 (UMLS CUI [1])
patients who are post-allogeneic transplantation should not have active gvhd greater than grade 1 of skin
Item
patients who are post-allogeneic transplantation should not have active gvhd greater than grade 1 of skin
boolean
C0018133 (UMLS CUI [1,1])
C1123023 (UMLS CUI [1,2])
pregnancy or breast feeding
Item
pregnant or breast feeding female subjects
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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