ID

13235

Description

Safety and Efficacy Study of PD-616 Plus Cytarabine to Treat Acute Myelogenous Leukemia or Myelodysplastic Syndrome; ODM derived from: https://clinicaltrials.gov/show/NCT01795924

Link

https://clinicaltrials.gov/show/NCT01795924

Keywords

Versions (1)
  1. 1/25/16 1/25/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 25, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Myelogenous Leukemia NCT01795924

English

Eligibility Acute Myelogenous Leukemia NCT01795924

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient has newly diagnosed aml and refuses or is not eligible for treatment with aggressive chemotherapy and/or sct; or aml and has relapsed or been refractory to prior therapy; or high-risk mds, defined as ipss intermediate-2 (int-2) or ipss high-risk, and refuses or is not eligible for standard or aggressive chemotherapy and sct or prior experimental therapies; or high-risk mds, defined as ipss int-2 or ipss high risk, and has failed or been refractory to deoxyribonucleic acid (dna) hypomethylating agents (azacitidine or decitabine), lenalidomide, standard/aggressive chemotherapy, sct, or prior experimental therapies.
Description

AML, MDS

Data type

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C3463824
has a bone marrow examination performed within 14 days before baseline (c1d1).
Description

bone marrow examination

Data type

boolean

Alias
UMLS CUI [1]
C0005957
has an ecog performance status score of 0 to 2.
Description

ECOG

Data type

boolean

Alias
UMLS CUI [1]
C1520224
aged between 18 and 75 years, inclusive.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
has a life expectancy of ≥3 months.
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
has the following laboratory parameters within 7 days before baseline (c1d1):serum creatinine ≤2 mg/dl; total bilirubin ≤2.0 mg/dl; alanine transaminase (alt) or aspartate transaminase (ast) <3.0×the upper limit of normal (uln); left ventricular ejection fraction (lvef) >40%; forced expiratory volume in 1 second (fev1) >60% of predicted.
Description

laboratory parameters

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0428772
UMLS CUI [6]
C0748133
if a female of child-bearing potential, has a negative serum pregnancy test result within 14 days before baseline and agrees to abstain from heterosexual intercourse or use a barrier method for contraception from 14 days before baseline (c1d1) through 30 days after the last study drug dose.
Description

pregnancy, contraception

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0700589
if male, agrees to use a latex condom during any sexual contact with a female of child-bearing potential.
Description

contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
able to understand and willing to provide written informed consent.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
has received prior treatment with pd-616 or low-dose cytarabine.
Description

prior treatment with pd-616 or low-dose cytarabine

Data type

boolean

Alias
UMLS CUI [1]
C0010711
has received chemotherapy (except hydroxyurea), biological therapy, radiotherapy or investigational therapy within 4 weeks before baseline (c1d1).
Description

chemotherapy (except hydroxyurea), biological therapy, radiotherapy or investigational therapy within 4 weeks before baseline

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C1531518
UMLS CUI [4]
C1875319
has active central nervous system (cns) involvement (documented by radiologic lesions and/or malignant cells in the cerebrospinal fluid [csf]).
Description

cns leukemia

Data type

boolean

Alias
UMLS CUI [1]
C1332884
has acute promyelocytic leukemia (apl, fab m3).
Description

APL

Data type

boolean

Alias
UMLS CUI [1]
C0023487
has another active systemic malignancy treated with chemotherapy within 12 months before baseline (c1d1).
Description

malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
has known human immunodeficiency virus (hiv) infection.
Description

HIV

Data type

boolean

Alias
UMLS CUI [1]
C0019682
has active graft-versus-host disease (gvhd).
Description

GvHD

Data type

boolean

Alias
UMLS CUI [1]
C0018133
has uncontrolled active infection of any kind. (patients with infections controlled by active antibiotic treatment are eligible).
Description

infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
has significant renal or hepatic disease, uncontrolled or severe cardiovascular or pulmonary diseases, or other uncontrolled medical condition that, based on the investigator's assessment, would compromise the patient's ability to tolerate study treatment or the assessment of treatment response.
Description

comorbidity compromising study protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
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Similar models

Eligibility Acute Myelogenous Leukemia NCT01795924

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML, MDS
Item
patient has newly diagnosed aml and refuses or is not eligible for treatment with aggressive chemotherapy and/or sct; or aml and has relapsed or been refractory to prior therapy; or high-risk mds, defined as ipss intermediate-2 (int-2) or ipss high-risk, and refuses or is not eligible for standard or aggressive chemotherapy and sct or prior experimental therapies; or high-risk mds, defined as ipss int-2 or ipss high risk, and has failed or been refractory to deoxyribonucleic acid (dna) hypomethylating agents (azacitidine or decitabine), lenalidomide, standard/aggressive chemotherapy, sct, or prior experimental therapies.
boolean
C0023467 (UMLS CUI [1])
C3463824 (UMLS CUI [2])
bone marrow examination
Item
has a bone marrow examination performed within 14 days before baseline (c1d1).
boolean
C0005957 (UMLS CUI [1])
ECOG
Item
has an ecog performance status score of 0 to 2.
boolean
C1520224 (UMLS CUI [1])
age
Item
aged between 18 and 75 years, inclusive.
boolean
C0001779 (UMLS CUI [1])
life expectancy
Item
has a life expectancy of ≥3 months.
boolean
C0023671 (UMLS CUI [1])
laboratory parameters
Item
has the following laboratory parameters within 7 days before baseline (c1d1):serum creatinine ≤2 mg/dl; total bilirubin ≤2.0 mg/dl; alanine transaminase (alt) or aspartate transaminase (ast) <3.0×the upper limit of normal (uln); left ventricular ejection fraction (lvef) >40%; forced expiratory volume in 1 second (fev1) >60% of predicted.
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0428772 (UMLS CUI [5])
C0748133 (UMLS CUI [6])
pregnancy, contraception
Item
if a female of child-bearing potential, has a negative serum pregnancy test result within 14 days before baseline and agrees to abstain from heterosexual intercourse or use a barrier method for contraception from 14 days before baseline (c1d1) through 30 days after the last study drug dose.
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
contraception
Item
if male, agrees to use a latex condom during any sexual contact with a female of child-bearing potential.
boolean
C0700589 (UMLS CUI [1])
informed consent
Item
able to understand and willing to provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
prior treatment with pd-616 or low-dose cytarabine
Item
has received prior treatment with pd-616 or low-dose cytarabine.
boolean
C0010711 (UMLS CUI [1])
chemotherapy (except hydroxyurea), biological therapy, radiotherapy or investigational therapy within 4 weeks before baseline
Item
has received chemotherapy (except hydroxyurea), biological therapy, radiotherapy or investigational therapy within 4 weeks before baseline (c1d1).
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C1531518 (UMLS CUI [3])
C1875319 (UMLS CUI [4])
cns leukemia
Item
has active central nervous system (cns) involvement (documented by radiologic lesions and/or malignant cells in the cerebrospinal fluid [csf]).
boolean
C1332884 (UMLS CUI [1])
APL
Item
has acute promyelocytic leukemia (apl, fab m3).
boolean
C0023487 (UMLS CUI [1])
malignancy
Item
has another active systemic malignancy treated with chemotherapy within 12 months before baseline (c1d1).
boolean
C0006826 (UMLS CUI [1])
HIV
Item
has known human immunodeficiency virus (hiv) infection.
boolean
C0019682 (UMLS CUI [1])
GvHD
Item
has active graft-versus-host disease (gvhd).
boolean
C0018133 (UMLS CUI [1])
infection
Item
has uncontrolled active infection of any kind. (patients with infections controlled by active antibiotic treatment are eligible).
boolean
C0009450 (UMLS CUI [1])
comorbidity compromising study protocol
Item
has significant renal or hepatic disease, uncontrolled or severe cardiovascular or pulmonary diseases, or other uncontrolled medical condition that, based on the investigator's assessment, would compromise the patient's ability to tolerate study treatment or the assessment of treatment response.
boolean
C2348563 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
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