ID

13592

Description

Study of XL999 in Patients With Acute Myeloid Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT00322673

Link

https://clinicaltrials.gov/show/NCT00322673

Keywords

Versions (1)
  1. 2/18/16 2/18/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

February 18, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT00322673

English

Eligibility Acute Myeloid Leukemia NCT00322673

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of acute myeloid leukemia (except aml fab-m3 or acute promyelocytic leukemia [apl]) based on the world health organization (who) classification of ≥ 20% blasts in the bone marrow or peripheral blood at initial diagnosis (prior to start of standard chemotherapy)
Description

diagnosis of acute myeloid leukemia (except aml fab-m3 or acute promyelocytic leukemia [apl]) based on the world health organization (who) classification of ≥ 20% blasts in the bone marrow or peripheral blood at initial diagnosis (prior to start of standard chemotherapy)

Data type

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C1982687
UMLS CUI [3]
C0368761
ecog performance status of 0 or 1
Description

ecog performance status of 0 or 1

Data type

boolean

Alias
UMLS CUI [1]
C1520224
subjects with newly-diagnosed aml or subjects with relapsed aml after at least 2 chemotherapy regimens.
Description

subjects with newly-diagnosed aml or subjects with relapsed aml after at least 2 chemotherapy regimens.

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C1518321
UMLS CUI [2,1]
C0023467
UMLS CUI [2,2]
C0277556
adequate liver and renal function
Description

adequate liver and renal function

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0232804
signed informed consent
Description

signed informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
anticancer therapy including chemotherapeutic, biologic, or investigative agents within 30 days of xl999 treatment
Description

anticancer therapy including chemotherapeutic, biologic, or investigative agents within 30 days of xl999 treatment

Data type

boolean

Alias
UMLS CUI [1]
C0920425
hematopoietic stem cell transplantation within the previous 6 weeks
Description

hematopoietic stem cell transplantation within the previous 6 weeks

Data type

boolean

Alias
UMLS CUI [1]
C1504389
immunosuppressive therapy (eg, cyclosporine, steroids, tacrolimus) for graft-versus-host disease (gvhd) within 30 days prior to the start of xl999
Description

immunosuppressive therapy (eg, cyclosporine, steroids, tacrolimus) for graft-versus-host disease (gvhd) within 30 days prior to the start of xl999

Data type

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C0018133
the subject has not recovered to grade ≤ 1 or to within 10% of baseline from adverse events due to investigational or chemotherapeutic drugs or stem cell transplantation which were administered > 4 weeks prior to study enrollment
Description

the subject has not recovered to grade ≤ 1 or to within 10% of baseline from adverse events due to investigational or chemotherapeutic drugs or stem cell transplantation which were administered > 4 weeks prior to study enrollment

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2004454
uncontrolled and/or concomitant illness
Description

uncontrolled and/or concomitant illness

Data type

boolean

Alias
UMLS CUI [1]
C0009488
pregnant or breastfeeding females
Description

pregnant or breastfeeding females

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
known hiv
Description

known hiv

Data type

boolean

Alias
UMLS CUI [1]
C0019682
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Similar models

Eligibility Acute Myeloid Leukemia NCT00322673

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML
Item
diagnosis of acute myeloid leukemia (except aml fab-m3 or acute promyelocytic leukemia [apl]) based on the world health organization (who) classification of ≥ 20% blasts in the bone marrow or peripheral blood at initial diagnosis (prior to start of standard chemotherapy)
boolean
C0023467 (UMLS CUI [1])
C1982687 (UMLS CUI [2])
C0368761 (UMLS CUI [3])
ecog
Item
ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
subjects with newly-diagnosed aml or subjects with relapsed aml after at least 2 chemotherapy regimens.
Item
subjects with newly-diagnosed aml or subjects with relapsed aml after at least 2 chemotherapy regimens.
boolean
C0023467 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
C0023467 (UMLS CUI [2,1])
C0277556 (UMLS CUI [2,2])
liver and renal function
Item
adequate liver and renal function
boolean
C0232741 (UMLS CUI [1,1])
C0232804 (UMLS CUI [1,2])
signed informed consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
anticancer therapy
Item
anticancer therapy including chemotherapeutic, biologic, or investigative agents within 30 days of xl999 treatment
boolean
C0920425 (UMLS CUI [1])
stem cell transplantation
Item
hematopoietic stem cell transplantation within the previous 6 weeks
boolean
C1504389 (UMLS CUI [1])
immunosuppressive therapy
Item
immunosuppressive therapy (eg, cyclosporine, steroids, tacrolimus) for graft-versus-host disease (gvhd) within 30 days prior to the start of xl999
boolean
C0021079 (UMLS CUI [1])
C0018133 (UMLS CUI [2])
adverse events recovery
Item
the subject has not recovered to grade ≤ 1 or to within 10% of baseline from adverse events due to investigational or chemotherapeutic drugs or stem cell transplantation which were administered > 4 weeks prior to study enrollment
boolean
C0877248 (UMLS CUI [1,1])
C2004454 (UMLS CUI [1,2])
uncontrolled and/or concomitant illness
Item
uncontrolled and/or concomitant illness
boolean
C0009488 (UMLS CUI [1])
pregnant or breastfeeding females
Item
pregnant or breastfeeding females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
hiv
Item
known hiv
boolean
C0019682 (UMLS CUI [1])
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