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ID
13999
Beschreibung
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
Stichworte
Versionen (1)
- 21.03.16 21.03.16 -
Hochgeladen am
21. März 2016
DOI
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Lizenz
Creative Commons BY 4.0
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Eligibility Acute Myeloid Leukemia NCT01702155
Eligibility Acute Myeloid Leukemia NCT01702155
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Acute Myeloid Leukemia NCT01702155
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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])
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])
C0700589 (UMLS CUI [2])
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])
C2711110 (UMLS CUI [2])
Blood Coagulation Disorders
Item
Documented or known clinically significant bleeding disorder
boolean
C0005779 (UMLS CUI [1])