ID

13999

Description

Phase I/II Study of DFP-10917 in Patients With Acute Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01702155

Link

https://clinicaltrials.gov/show/NCT01702155

Keywords

Versions (1)
  1. 3/21/16 3/21/16 -
Uploaded on

March 21, 2016

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 Acute Myeloid Leukemia NCT01702155

English

Eligibility Acute Myeloid Leukemia NCT01702155

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Patients must have pathologically-confirmed acute leukemia, refractory or relapsed after standard therapy for the disease or for which conventional systemic chemotherapy is not reliably effective or no effective therapy is available phase ii only: patient must have histologically or pathologically confirmed diagnosis of aml based on who classification that is refractory after standard therapy, or for which conventional systemic chemotherapy is not reliably effective, or no effective therapy is available. patients aged 60 years or older with newly diagnosed aml who are not eligible for, or who refuse, standard care are also eligible.
Description

Acute leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0085669
Aged ≥ 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Ecog performance status of 0, 1 or 2
Description

ECOG Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Adequate clinical laboratory values (i.e., plasma creatinine <= 1.5 x upper limit of normal (uln) for the institution, bilirubin <=1.5 x uln, alanine transaminase (alt) and aspartate transaminase (ast) <= 2.5 x uln).
Description

Laboratory Results

Data type

boolean

Alias
UMLS CUI [1]
C1254595
Absence of cns involvement by leukemia.
Description

CNS involvement status

Data type

boolean

Alias
UMLS CUI [1]
C0449389
Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.
Description

Communicable Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0026766
Signed informed consent prior to the start of any study specific procedures.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Women of child-bearing potential must have a negative serum or urine pregnancy test. male and female patients must agree to use acceptable contraceptive methods for the duration of the study and for at least one month after the last drug administration.
Description

Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0232973
UMLS CUI [2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
The interval from prior treatment to time of study drug administration is < 2 weeks for cytotoxic agents or < 5 half-lives for noncytotoxic agents. exceptions: use of hydroxyurea is allowed before the start of study and may be administered up to day 5 of the first cycle.
Description

Cytotoxic agent

Data type

boolean

Alias
UMLS CUI [1]
C0304497
Any >grade 1 persistent clinically significant toxicities from prior chemotherapy.
Description

Cytotoxic Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0677881
Extensive prior radiotherapy to more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation.
Description

Bone Marrow

Data type

boolean

Alias
UMLS CUI [1]
C0005953
Any concomitant condition that in the opinion of the investigator could compromise the objectives of this study and the patient's compliance.
Description

Concomitant conditions

Data type

boolean

Alias
UMLS CUI [1]
C0243086
A pregnant or lactating woman
Description

A pregnant or lactating woman

Data type

boolean

Alias
UMLS CUI [1]
C3242212
Current malignancies of another type. exceptions: patients may participate if they have previously treated and currently controlled prostate cancer, adequately treated in situ cervical cancer and basal cell skin cancer or other malignancies with no evidence of disease for 2 years or more.
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
Patient has acute promyelocytic leukemia (apl).
Description

Acute Promyelocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0023487
Patients with known hiv, hbv or hcv infection (note: testing for these infections is not required).
Description

HIV, Hepatitis B and hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C2711110
Documented or known clinically significant bleeding disorder
Description

Blood Coagulation Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0005779
Back to the top of the page

Similar models

Eligibility Acute Myeloid Leukemia NCT01702155

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Acute leukemia
Item
Patients must have pathologically-confirmed acute leukemia, refractory or relapsed after standard therapy for the disease or for which conventional systemic chemotherapy is not reliably effective or no effective therapy is available phase ii only: patient must have histologically or pathologically confirmed diagnosis of aml based on who classification that is refractory after standard therapy, or for which conventional systemic chemotherapy is not reliably effective, or no effective therapy is available. patients aged 60 years or older with newly diagnosed aml who are not eligible for, or who refuse, standard care are also eligible.
boolean
C0085669 (UMLS CUI [1])
Age
Item
Aged ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG Performance Status
Item
Ecog performance status of 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
Laboratory Results
Item
Adequate clinical laboratory values (i.e., plasma creatinine <= 1.5 x upper limit of normal (uln) for the institution, bilirubin <=1.5 x uln, alanine transaminase (alt) and aspartate transaminase (ast) <= 2.5 x uln).
boolean
C1254595 (UMLS CUI [1])
CNS involvement status
Item
Absence of cns involvement by leukemia.
boolean
C0449389 (UMLS CUI [1])
Communicable Diseases
Item
Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.
boolean
C0009450 (UMLS CUI [1])
C0026766 (UMLS CUI [2])
Informed Consent
Item
Signed informed consent prior to the start of any study specific procedures.
boolean
C0021430 (UMLS CUI [1])
Contraceptive methods
Item
Women of child-bearing potential must have a negative serum or urine pregnancy test. male and female patients must agree to use acceptable contraceptive methods for the duration of the study and for at least one month after the last drug administration.
boolean
C0232973 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Cytotoxic agent
Item
The interval from prior treatment to time of study drug administration is < 2 weeks for cytotoxic agents or < 5 half-lives for noncytotoxic agents. exceptions: use of hydroxyurea is allowed before the start of study and may be administered up to day 5 of the first cycle.
boolean
C0304497 (UMLS CUI [1])
Cytotoxic Chemotherapy
Item
Any >grade 1 persistent clinically significant toxicities from prior chemotherapy.
boolean
C0677881 (UMLS CUI [1])
Bone Marrow
Item
Extensive prior radiotherapy to more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation.
boolean
C0005953 (UMLS CUI [1])
Concomitant conditions
Item
Any concomitant condition that in the opinion of the investigator could compromise the objectives of this study and the patient's compliance.
boolean
C0243086 (UMLS CUI [1])
A pregnant or lactating woman
Item
A pregnant or lactating woman
boolean
C3242212 (UMLS CUI [1])
Malignant Neoplasms
Item
Current malignancies of another type. exceptions: patients may participate if they have previously treated and currently controlled prostate cancer, adequately treated in situ cervical cancer and basal cell skin cancer or other malignancies with no evidence of disease for 2 years or more.
boolean
C0006826 (UMLS CUI [1])
Acute Promyelocytic Leukemia
Item
Patient has acute promyelocytic leukemia (apl).
boolean
C0023487 (UMLS CUI [1])
HIV, Hepatitis B and hepatitis C
Item
Patients with known hiv, hbv or hcv infection (note: testing for these infections is not required).
boolean
C0019682 (UMLS CUI [1])
C2711110 (UMLS CUI [2])
Blood Coagulation Disorders
Item
Documented or known clinically significant bleeding disorder
boolean
C0005779 (UMLS CUI [1])
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