ID

30993

Description

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

Keywords

Versions (2)
  1. 7/8/18 7/8/18 -
  2. 7/9/18 7/9/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 9, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Myeloid Leukemia NCT00543972

English

Eligibility Myeloid Leukemia NCT00543972

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

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

Data type

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
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

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

Gemtuzumab ozogamicin | Mylotarg

Data type

boolean

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

Transplantation, Homologous

Data type

boolean

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

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

Data type

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
Description

AVE9633

Data type

boolean

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

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

Data type

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
Description

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

Data type

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
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Females & males of reproductive potential Contraceptive methods Absent

Data type

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.
Description

Eligibility Criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1524062
Back to the top of the page

Similar models

Eligibility Myeloid Leukemia NCT00543972

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial