ID

36993

Descrição

Study of MEN1112 Intravenous Infusion in Relapsed or Refractory Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT02353143

Link

https://clinicaltrials.gov/show/NCT02353143

Palavras-chave

Versões (1)
  1. 26/06/2019 26/06/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

26 de junho de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Recurrent Adult Acute Myeloid Leukemia NCT02353143

Inglês

Eligibility Recurrent Adult Acute Myeloid Leukemia NCT02353143

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients aged ≥ 18 years.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
documented definitive diagnosis of aml (according to who criteria, 2008) that is relapsed/refractory to standard treatment, for which no standard therapy is available or the patient refuses standard therapy.
Descrição

Leukemia, Myelocytic, Acute | Standard of Care AML recurrent | Standard of Care Refractory AML | Standard of Care Unavailable | Standard of Care Refused

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2,1]
C2936643
UMLS CUI [2,2]
C1142169
UMLS CUI [3,1]
C2936643
UMLS CUI [3,2]
C4528668
UMLS CUI [4,1]
C2936643
UMLS CUI [4,2]
C0686905
UMLS CUI [5,1]
C2936643
UMLS CUI [5,2]
C1705116
wbc count ≤ 10 x 109/l at visit 1 (day 1); hydroyxurea is allowed to lower wbc count up to one day prior the first study drug administration.
Descrição

White Blood Cell Count procedure | Hydroxyurea allowed | Hydroxyurea Lowering White Blood Cell Count

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2,1]
C0020402
UMLS CUI [2,2]
C0683607
UMLS CUI [3,1]
C0020402
UMLS CUI [3,2]
C2003888
UMLS CUI [3,3]
C0023508
eastern cooperative oncology group (ecog) performance status of 0 to 2 at visit 1 (day 1).
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of at least 2 months.
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
adequate renal and hepatic laboratory assessments: aspartate aminotransferase (ast), alanine aminotransferase (alt) and alkaline phosphatase (alp) ≤3.0 × uln, unless considered due to leukemic organ involvement, total bilirubin ≤2.0 × uln, serum creatinine ≤2.0 × uln.
Descrição

Laboratory test renal | Laboratory test hepatic | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Exception Organ Involvement with Leukemia | Serum total bilirubin measurement | Creatinine measurement, serum

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0022646
UMLS CUI [2,1]
C0022885
UMLS CUI [2,2]
C0205054
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201850
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0178784
UMLS CUI [6,3]
C1314939
UMLS CUI [6,4]
C0023418
UMLS CUI [7]
C1278039
UMLS CUI [8]
C0201976
able to give written informed consent before any study related procedure
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
acute promyelocytic leukaemia (french-american-british m3 classification).
Descrição

Acute Promyelocytic Leukemia French-American-British Classification

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023487
UMLS CUI [1,2]
C2984084
active central nervous system involvement.
Descrição

Central Nervous System Involvement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4050309
haematopoietic stem cell transplantation (hsct) performed within 3 months prior to screening visit.
Descrição

Hemopoietic stem cell transplant

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0472699
active infection requiring intravenous antibiotics.
Descrição

Communicable Disease Requirement Antibiotics Intravenous

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003232
UMLS CUI [1,4]
C1522726
life-threatening illnesses other than aml, uncontrolled medical conditions or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety or interfere with the patient's ability to comply with the study activities.
Descrição

Life threatening illness compromises Patient safety | Life threatening illness Interferes with Protocol Compliance | Exception AML | Medical condition Uncontrolled | Organ system Dysfunction

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3846017
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C3846017
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0023467
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0205318
UMLS CUI [5,1]
C0682591
UMLS CUI [5,2]
C3887504
anti-tumour therapy within 14 days of study visit 1 (day 1, excluding hydroxyurea).
Descrição

Cancer treatment | Exception Hydroxyurea

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0020402
prior participation in an investigational study (procedure or device) within 21 days of study visit 1 (day 1).
Descrição

Study Subject Participation Status | Procedure Investigational | Investigational Medical Device

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C1517586
UMLS CUI [3]
C2346570
radiotherapy within 28 days prior to study visit 1 (day 1) or scheduled along the study conduct.
Descrição

Therapeutic radiology procedure | Therapeutic radiology procedure Scheduled

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0205539
known history of human immunodeficiency virus (hiv) or active infection with hepatitis c virus (hcv) or hepatitis b virus (hbv).
Descrição

HIV Infection | Hepatitis C | Hepatitis B

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019163
other active malignancies. history of malignancy in the last 12 months (except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast or non-melanoma skin cancer).
Descrição

Cancer Other | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Breast Carcinoma | Exception Skin carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0678222
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0699893
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Similar models

Eligibility Recurrent Adult Acute Myeloid Leukemia NCT02353143

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female patients aged ≥ 18 years.
boolean
C0001779 (UMLS CUI [1])
Leukemia, Myelocytic, Acute | Standard of Care AML recurrent | Standard of Care Refractory AML | Standard of Care Unavailable | Standard of Care Refused
Item
documented definitive diagnosis of aml (according to who criteria, 2008) that is relapsed/refractory to standard treatment, for which no standard therapy is available or the patient refuses standard therapy.
boolean
C0023467 (UMLS CUI [1])
C2936643 (UMLS CUI [2,1])
C1142169 (UMLS CUI [2,2])
C2936643 (UMLS CUI [3,1])
C4528668 (UMLS CUI [3,2])
C2936643 (UMLS CUI [4,1])
C0686905 (UMLS CUI [4,2])
C2936643 (UMLS CUI [5,1])
C1705116 (UMLS CUI [5,2])
White Blood Cell Count procedure | Hydroxyurea allowed | Hydroxyurea Lowering White Blood Cell Count
Item
wbc count ≤ 10 x 109/l at visit 1 (day 1); hydroyxurea is allowed to lower wbc count up to one day prior the first study drug administration.
boolean
C0023508 (UMLS CUI [1])
C0020402 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C0020402 (UMLS CUI [3,1])
C2003888 (UMLS CUI [3,2])
C0023508 (UMLS CUI [3,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 to 2 at visit 1 (day 1).
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 2 months.
boolean
C0023671 (UMLS CUI [1])
Laboratory test renal | Laboratory test hepatic | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Exception Organ Involvement with Leukemia | Serum total bilirubin measurement | Creatinine measurement, serum
Item
adequate renal and hepatic laboratory assessments: aspartate aminotransferase (ast), alanine aminotransferase (alt) and alkaline phosphatase (alp) ≤3.0 × uln, unless considered due to leukemic organ involvement, total bilirubin ≤2.0 × uln, serum creatinine ≤2.0 × uln.
boolean
C0022885 (UMLS CUI [1,1])
C0022646 (UMLS CUI [1,2])
C0022885 (UMLS CUI [2,1])
C0205054 (UMLS CUI [2,2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201850 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C0178784 (UMLS CUI [6,2])
C1314939 (UMLS CUI [6,3])
C0023418 (UMLS CUI [6,4])
C1278039 (UMLS CUI [7])
C0201976 (UMLS CUI [8])
Informed Consent
Item
able to give written informed consent before any study related procedure
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Acute Promyelocytic Leukemia French-American-British Classification
Item
acute promyelocytic leukaemia (french-american-british m3 classification).
boolean
C0023487 (UMLS CUI [1,1])
C2984084 (UMLS CUI [1,2])
Central Nervous System Involvement
Item
active central nervous system involvement.
boolean
C4050309 (UMLS CUI [1])
Hemopoietic stem cell transplant
Item
haematopoietic stem cell transplantation (hsct) performed within 3 months prior to screening visit.
boolean
C0472699 (UMLS CUI [1])
Communicable Disease Requirement Antibiotics Intravenous
Item
active infection requiring intravenous antibiotics.
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
C1522726 (UMLS CUI [1,4])
Life threatening illness compromises Patient safety | Life threatening illness Interferes with Protocol Compliance | Exception AML | Medical condition Uncontrolled | Organ system Dysfunction
Item
life-threatening illnesses other than aml, uncontrolled medical conditions or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety or interfere with the patient's ability to comply with the study activities.
boolean
C3846017 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C3846017 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0023467 (UMLS CUI [3,2])
C3843040 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0682591 (UMLS CUI [5,1])
C3887504 (UMLS CUI [5,2])
Cancer treatment | Exception Hydroxyurea
Item
anti-tumour therapy within 14 days of study visit 1 (day 1, excluding hydroxyurea).
boolean
C0920425 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0020402 (UMLS CUI [2,2])
Study Subject Participation Status | Procedure Investigational | Investigational Medical Device
Item
prior participation in an investigational study (procedure or device) within 21 days of study visit 1 (day 1).
boolean
C2348568 (UMLS CUI [1])
C0184661 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C2346570 (UMLS CUI [3])
Therapeutic radiology procedure | Therapeutic radiology procedure Scheduled
Item
radiotherapy within 28 days prior to study visit 1 (day 1) or scheduled along the study conduct.
boolean
C1522449 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
HIV Infection | Hepatitis C | Hepatitis B
Item
known history of human immunodeficiency virus (hiv) or active infection with hepatitis c virus (hcv) or hepatitis b virus (hbv).
boolean
C0019693 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
Cancer Other | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Breast Carcinoma | Exception Skin carcinoma
Item
other active malignancies. history of malignancy in the last 12 months (except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast or non-melanoma skin cancer).
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0678222 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0699893 (UMLS CUI [6,2])
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