ID

13999

Descripción

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

Palabras clave

Versiones (1)
  1. 21/3/16 21/3/16 -
Subido en

21 de marzo de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Acute Myeloid Leukemia NCT01702155

Inglés

Eligibility Acute Myeloid Leukemia NCT01702155

1 formularios  
Inclusion Criteria
Descripción

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.
Descripción

Acute leukemia

Tipo de datos

boolean

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

Age

Tipo de datos

boolean

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

ECOG Performance Status

Tipo de datos

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).
Descripción

Laboratory Results

Tipo de datos

boolean

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

CNS involvement status

Tipo de datos

boolean

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

Communicable Diseases

Tipo de datos

boolean

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

Informed Consent

Tipo de datos

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.
Descripción

Contraceptive methods

Tipo de datos

boolean

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

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.
Descripción

Cytotoxic agent

Tipo de datos

boolean

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

Cytotoxic Chemotherapy

Tipo de datos

boolean

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

Bone Marrow

Tipo de datos

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.
Descripción

Concomitant conditions

Tipo de datos

boolean

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

A pregnant or lactating woman

Tipo de datos

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.
Descripción

Malignant Neoplasms

Tipo de datos

boolean

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

Acute Promyelocytic Leukemia

Tipo de datos

boolean

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

HIV, Hepatitis B and hepatitis C

Tipo de datos

boolean

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

Blood Coagulation Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005779
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Similar models

Eligibility Acute Myeloid Leukemia NCT01702155

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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