ID

30993

Beschrijving

Dose Escalation Safety and Pharmacokinetic Study of AVE9633 as Single Agent in Relapsed/Refractory CD33-Positive Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00543972

Link

https://clinicaltrials.gov/show/NCT00543972

Trefwoorden

Versies (2)
  1. 7/8/18 7/8/18 -
  2. 7/9/18 7/9/18 -
Houder van rechten

See clinicaltrials.gov

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July 9, 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Myeloid Leukemia NCT00543972

Engels

Eligibility Myeloid Leukemia NCT00543972

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with cd33-positive acute myeloid leukemia, refractory or relapsed after standard treatment with no curative option available
Beschrijving

Refractory Acute Myeloid Leukemia CD33 Positive | Acute Myelocytic Leukemia Relapse CD33 Positive | Status post Standard of Care | Curative treatment Lacking

Datatype

boolean

Alias
UMLS CUI [1,1]
C4528668
UMLS CUI [1,2]
C4329511
UMLS CUI [2,1]
C0023467
UMLS CUI [2,2]
C0035020
UMLS CUI [2,3]
C4329511
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C2936643
UMLS CUI [4,1]
C1273390
UMLS CUI [4,2]
C0332268
ecog performance status 0 to 2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
therapy with gemtuzumab ozogamicin (mylotarg) within 6 months prior to inclusion
Beschrijving

Gemtuzumab ozogamicin | Mylotarg

Datatype

boolean

Alias
UMLS CUI [1]
C1533699
UMLS CUI [2]
C0876099
allogenic transplantation within 6 months prior to inclusion
Beschrijving

Transplantation, Homologous

Datatype

boolean

Alias
UMLS CUI [1]
C0040739
prior therapy (chemotherapy, targeted agents, radiotherapy) within 3 weeks except for hydroxyurea and for leukophoresis
Beschrijving

Prior Therapy | Chemotherapy | Targeted Therapy | Therapeutic radiology procedure | Exception Hydroxyurea | Exception Leukapheresis

Datatype

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C0392920
UMLS CUI [3]
C2985566
UMLS CUI [4]
C1522449
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0020402
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0023416
previous treatment with ave9633
Beschrijving

AVE9633

Datatype

boolean

Alias
UMLS CUI [1]
C3501972
poor kidney, liver and bone marrow functions
Beschrijving

Renal function Poor | Liver function Poor | Poor bone marrow function

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0542537
UMLS CUI [2,1]
C0232741
UMLS CUI [2,2]
C0542537
UMLS CUI [3]
C1389329
any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study
Beschrijving

Disease Serious Interferes with Patient safety | Comorbidity Serious Interferes with Patient safety | Disease Serious Interferes with Protocol Compliance | Comorbidity Serious Interferes with Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C1113679
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C1113679
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C0525058
UMLS CUI [4,1]
C0009488
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C0521102
UMLS CUI [4,4]
C0525058
pregnant or breast-feeding women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patient with reproductive potential without effective birth control methods
Beschrijving

Females & males of reproductive potential Contraceptive methods Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Beschrijving

Eligibility Criteria Additional

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Myeloid Leukemia NCT00543972

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Refractory Acute Myeloid Leukemia CD33 Positive | Acute Myelocytic Leukemia Relapse CD33 Positive | Status post Standard of Care | Curative treatment Lacking
Item
patients with cd33-positive acute myeloid leukemia, refractory or relapsed after standard treatment with no curative option available
boolean
C4528668 (UMLS CUI [1,1])
C4329511 (UMLS CUI [1,2])
C0023467 (UMLS CUI [2,1])
C0035020 (UMLS CUI [2,2])
C4329511 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C2936643 (UMLS CUI [3,2])
C1273390 (UMLS CUI [4,1])
C0332268 (UMLS CUI [4,2])
ECOG performance status
Item
ecog performance status 0 to 2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Gemtuzumab ozogamicin | Mylotarg
Item
therapy with gemtuzumab ozogamicin (mylotarg) within 6 months prior to inclusion
boolean
C1533699 (UMLS CUI [1])
C0876099 (UMLS CUI [2])
Transplantation, Homologous
Item
allogenic transplantation within 6 months prior to inclusion
boolean
C0040739 (UMLS CUI [1])
Prior Therapy | Chemotherapy | Targeted Therapy | Therapeutic radiology procedure | Exception Hydroxyurea | Exception Leukapheresis
Item
prior therapy (chemotherapy, targeted agents, radiotherapy) within 3 weeks except for hydroxyurea and for leukophoresis
boolean
C1514463 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C2985566 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0020402 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0023416 (UMLS CUI [6,2])
AVE9633
Item
previous treatment with ave9633
boolean
C3501972 (UMLS CUI [1])
Renal function Poor | Liver function Poor | Poor bone marrow function
Item
poor kidney, liver and bone marrow functions
boolean
C0232804 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2,1])
C0542537 (UMLS CUI [2,2])
C1389329 (UMLS CUI [3])
Disease Serious Interferes with Patient safety | Comorbidity Serious Interferes with Patient safety | Disease Serious Interferes with Protocol Compliance | Comorbidity Serious Interferes with Protocol Compliance
Item
any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C1113679 (UMLS CUI [2,4])
C0012634 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0525058 (UMLS CUI [3,4])
C0009488 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C0525058 (UMLS CUI [4,4])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Females & males of reproductive potential Contraceptive methods Absent
Item
patient with reproductive potential without effective birth control methods
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Eligibility Criteria Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C1516637 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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