ID

13349

Description

PF-05212384 (PKI-587) for t-AML/MDS or de Novo Relapsed or Refractory Acute Myeloid Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT02438761

Link

https://clinicaltrials.gov/show/NCT02438761

Keywords

Versions (1)
  1. 2/7/16 2/7/16 -
Uploaded on

February 7, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Therapy-related Acute Myeloid Leukemia and Myelodysplastic Syndrome NCT02438761

English

Eligibility Therapy-related Acute Myeloid Leukemia and Myelodysplastic Syndrome NCT02438761

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Patients belong to one of three categories:
Description

Patients belong to one of three categories:

Data type

boolean

Alias
UMLS CUI [1]
C2827031
Myeloid neoplasm secondary to chemo-radiotherapy (t-aml/mds) aged 60 and over with unfavorable cytogenetics (european leukemia network definition 2010), the first cancer must have been in remission for more than two years, except in situ carcinoma, basal cell carcinoma and squamous cell carcinoma
Description

Myeloid neoplasm secondary to chemo-radiotherapy (t-aml/mds)

Data type

boolean

Alias
UMLS CUI [1]
C0280449
relapsed or refractory de novo aml aged 18 and over (multiple relapses allowed), regardless of the risk group, provided not being eligible for allogeneic bone marrow transplantation
Description

Relapsed or refractory de novo aml

Data type

boolean

Alias
UMLS CUI [1]
C1275661
UMLS CUI [2]
C0023467
De novo aml at diagnosis, aged 60 and over and considered unfit to benefit from induction chemotherapy associated with aplasia (at the discretion of the investigator)
Description

De novo aml at diagnosis

Data type

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C3179010
Adequate glycemic control defined by glycated hemoglobin ≤ 8%
Description

Adequate glycemic balance

Data type

boolean

Alias
UMLS CUI [1]
C0017853
Female of childbearing potential (fcbp) should receive effective contraception: a negative pregnancy blood test is required within 2 weeks before starting experimental treatment.
Description

Female of childbearing potential (fcbp)

Data type

boolean

Alias
UMLS CUI [1]
C3831118
Eastern cooperative oncology group (ecog) performance status (ps) ≤ 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Absence of severe or active infection
Description

Absence of severe or active infection

Data type

boolean

Alias
UMLS CUI [1]
C2712105
Adequate systolic cardiac function : left ventricular ejection fraction (lvef) ≥ 50%
Description

Systolic cardiac function

Data type

boolean

Alias
UMLS CUI [1]
C0438176
UMLS CUI [2]
C0428772
Adequate hepatic function: aspartate aminotransferase test (ast) and alanine aminotransferase test (alt) ≤ 3 times the upper limit of normal (uln), bilirubin ≤ 1,5 * upper limit of normall
Description

Adequate hepatic function

Data type

boolean

Alias
UMLS CUI [1]
C1848676
Adequate renal function: serum creatinine ≤ 1.5 x uln or calculated creatinine clearance > 60 ml/min.
Description

Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232805
Signed informed consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Glucose intolerance or diabetes mellitus, treated or untreated
Description

Glucose intolerance or diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0271650
UMLS CUI [2]
C0011849
First cancer in evolution (solid tumor or lymphoma) or in remission for less than two years, except in situ carcinoma, basal cell carcinoma and squamous cell carcinoma
Description

First cancer

Data type

boolean

Alias
UMLS CUI [1]
C3172269
Aml secondary to mds or myeloproliferative syndrome (who 2008 definitions)
Description

Aml secondary to mds

Data type

boolean

Alias
UMLS CUI [1]
C3463824
Acute promyelocytic leukaemia (apl or aml french american british (fab) classification 3) de novo or secondary to treatment (t-apl)
Description

Acute promyelocytic leukaemia

Data type

boolean

Alias
UMLS CUI [1]
C0023487
De novo or secondary core binding factor (cbf)/aml
Description

De novo or secondary core binding factor (cbf)/aml

Data type

boolean

Alias
UMLS CUI [1]
C0212320
De novo or secondary philadelphia chromosome (ph) 1 positive aml defined by the presence of a t(9.22) or a breakpoint cluster region-abelson murine leukemia viral oncogene homolog (bcr-abl) transcript
Description

De novo or secondary philadelphia chromosome (ph) 1 positive aml

Data type

boolean

Alias
UMLS CUI [1]
C0856536
Leukocytes above 30.000/mm3 (30 g/l) at enrollment
Description

Leukocytes above 30.000/mm3

Data type

boolean

Alias
UMLS CUI [1]
C0152009
Antileukemic treatment within 15 days before enrollment, with the exception of hydroxyurea
Description

Antileukemic treatment

Data type

boolean

Alias
UMLS CUI [1]
C2825306
Central nervous system leukemic involvement
Description

Central nervous system leukemic involvement

Data type

boolean

Alias
UMLS CUI [1]
C0449389
Pregnant or lactating women, or women of childbearing potential without effective contraception
Description

Pregnant or lactating women

Data type

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C2828358
Prior history of allogeneic bone marrow transplantation
Description

Prior history of allogeneic bone marrow transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0149615
Prior history of organ transplantation or other cause of severe or chronic immunodeficiency human
Description

Prior history of organ transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0029216
Seropositivity for human immunodeficiency virus (hiv) or human t-lymphotropic virus-1 (htlv-1) viruses, active b or c hepatitis
Description

Hiv, Htlv, Hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0086427
UMLS CUI [3]
C0744827
Inclusion in another experimental anti-cancer clinical trial
Description

Inclusion in another experimental anti-cancer clinical trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Patients unable to undergo medical monitoring for geographical, social or psychological issues
Description

Patients unable to undergo medical monitoring for geographical, social or psychological issues

Data type

boolean

Alias
UMLS CUI [1]
C3899573
Person under a legal protection measure
Description

Person under a legal protection measure

Data type

boolean

Alias
UMLS CUI [1,1]
C1301860
UMLS CUI [1,2]
C1545588
No social security
Description

No social security

Data type

boolean

Alias
UMLS CUI [1]
C0037435
For ethical reasons, the exclusion period before considering the possibility of participating in another clinical study with a new experimental molecule cannot be determined, yet each case will be discussed on an individual basis with the study coordinator.
Description

Ethical issues

Data type

boolean

Alias
UMLS CUI [1]
C0086264
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Similar models

Eligibility Therapy-related Acute Myeloid Leukemia and Myelodysplastic Syndrome NCT02438761

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Patients belong to one of three categories:
Item
Patients belong to one of three categories:
boolean
C2827031 (UMLS CUI [1])
Myeloid neoplasm secondary to chemo-radiotherapy (t-aml/mds)
Item
Myeloid neoplasm secondary to chemo-radiotherapy (t-aml/mds) aged 60 and over with unfavorable cytogenetics (european leukemia network definition 2010), the first cancer must have been in remission for more than two years, except in situ carcinoma, basal cell carcinoma and squamous cell carcinoma
boolean
C0280449 (UMLS CUI [1])
Relapsed or refractory de novo aml
Item
relapsed or refractory de novo aml aged 18 and over (multiple relapses allowed), regardless of the risk group, provided not being eligible for allogeneic bone marrow transplantation
boolean
C1275661 (UMLS CUI [1])
C0023467 (UMLS CUI [2])
De novo aml at diagnosis
Item
De novo aml at diagnosis, aged 60 and over and considered unfit to benefit from induction chemotherapy associated with aplasia (at the discretion of the investigator)
boolean
C0023467 (UMLS CUI [1])
C3179010 (UMLS CUI [2])
Adequate glycemic balance
Item
Adequate glycemic control defined by glycated hemoglobin ≤ 8%
boolean
C0017853 (UMLS CUI [1])
Female of childbearing potential (fcbp)
Item
Female of childbearing potential (fcbp) should receive effective contraception: a negative pregnancy blood test is required within 2 weeks before starting experimental treatment.
boolean
C3831118 (UMLS CUI [1])
ECOG performance status
Item
Eastern cooperative oncology group (ecog) performance status (ps) ≤ 2
boolean
C1520224 (UMLS CUI [1])
Absence of severe or active infection
Item
Absence of severe or active infection
boolean
C2712105 (UMLS CUI [1])
Systolic cardiac function
Item
Adequate systolic cardiac function : left ventricular ejection fraction (lvef) ≥ 50%
boolean
C0438176 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Adequate hepatic function
Item
Adequate hepatic function: aspartate aminotransferase test (ast) and alanine aminotransferase test (alt) ≤ 3 times the upper limit of normal (uln), bilirubin ≤ 1,5 * upper limit of normall
boolean
C1848676 (UMLS CUI [1])
Renal function
Item
Adequate renal function: serum creatinine ≤ 1.5 x uln or calculated creatinine clearance > 60 ml/min.
boolean
C0232805 (UMLS CUI [1])
Informed consent
Item
Signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Glucose intolerance or diabetes mellitus
Item
Glucose intolerance or diabetes mellitus, treated or untreated
boolean
C0271650 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
First cancer
Item
First cancer in evolution (solid tumor or lymphoma) or in remission for less than two years, except in situ carcinoma, basal cell carcinoma and squamous cell carcinoma
boolean
C3172269 (UMLS CUI [1])
Aml secondary to mds
Item
Aml secondary to mds or myeloproliferative syndrome (who 2008 definitions)
boolean
C3463824 (UMLS CUI [1])
Acute promyelocytic leukaemia
Item
Acute promyelocytic leukaemia (apl or aml french american british (fab) classification 3) de novo or secondary to treatment (t-apl)
boolean
C0023487 (UMLS CUI [1])
De novo or secondary core binding factor (cbf)/aml
Item
De novo or secondary core binding factor (cbf)/aml
boolean
C0212320 (UMLS CUI [1])
De novo or secondary philadelphia chromosome (ph) 1 positive aml
Item
De novo or secondary philadelphia chromosome (ph) 1 positive aml defined by the presence of a t(9.22) or a breakpoint cluster region-abelson murine leukemia viral oncogene homolog (bcr-abl) transcript
boolean
C0856536 (UMLS CUI [1])
Leukocytes above 30.000/mm3
Item
Leukocytes above 30.000/mm3 (30 g/l) at enrollment
boolean
C0152009 (UMLS CUI [1])
Antileukemic treatment
Item
Antileukemic treatment within 15 days before enrollment, with the exception of hydroxyurea
boolean
C2825306 (UMLS CUI [1])
Central nervous system leukemic involvement
Item
Central nervous system leukemic involvement
boolean
C0449389 (UMLS CUI [1])
Pregnant or lactating women
Item
Pregnant or lactating women, or women of childbearing potential without effective contraception
boolean
C0549206 (UMLS CUI [1])
C2828358 (UMLS CUI [2])
Prior history of allogeneic bone marrow transplantation
Item
Prior history of allogeneic bone marrow transplantation
boolean
C0149615 (UMLS CUI [1])
Prior history of organ transplantation
Item
Prior history of organ transplantation or other cause of severe or chronic immunodeficiency human
boolean
C0029216 (UMLS CUI [1])
Hiv, Htlv, Hepatitis
Item
Seropositivity for human immunodeficiency virus (hiv) or human t-lymphotropic virus-1 (htlv-1) viruses, active b or c hepatitis
boolean
C0019682 (UMLS CUI [1])
C0086427 (UMLS CUI [2])
C0744827 (UMLS CUI [3])
Inclusion in another experimental anti-cancer clinical trial
Item
Inclusion in another experimental anti-cancer clinical trial
boolean
C2348568 (UMLS CUI [1])
Patients unable to undergo medical monitoring for geographical, social or psychological issues
Item
Patients unable to undergo medical monitoring for geographical, social or psychological issues
boolean
C3899573 (UMLS CUI [1])
Person under a legal protection measure
Item
Person under a legal protection measure
boolean
C1301860 (UMLS CUI [1,1])
C1545588 (UMLS CUI [1,2])
No social security
Item
No social security
boolean
C0037435 (UMLS CUI [1])
Ethical issues
Item
For ethical reasons, the exclusion period before considering the possibility of participating in another clinical study with a new experimental molecule cannot be determined, yet each case will be discussed on an individual basis with the study coordinator.
boolean
C0086264 (UMLS CUI [1])
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