KCT0002421
Completed
未知
Phase 1 study to evaluate safety and pharmacokinetic property of DNP001 in patients with JL1 postive acute leukemia or myelodysplastic syndrome
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Asan Medical Center
- Enrollment
- 18
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. \=19 years
- •2\. Diagnosed with JL1\-positive\* acute leukemia, acute\-stage chronic leukemia or myelodysplastic syndrome on tissue biopsy and showed recurrence to or non\-responsive to standard therapy, or patients with \=65 years where high\-intensive standard chemotherapy is not adequate (\*JL\-1\-positive is determine as ?10% of JL1 positive cells unon analysis by flow cytometry)
- •3\. Patients who did not have (or recoveredfrom its side effects) opration, radiation therapy, Treitinoin treatment, arsenic trioxide treatment, immunotherapy, methylation inhibitor therapy or chemotherapy within 4 weeks period prior to participating in the study. Except administration of hydroxyurea is permitted but has to be stopped 24 hr prior to the administration of study drug
- •4\. Patients with \= 2 Eastern Cooperative Oncology Group (ECOG) performance status
- •5\. Patients with life expectancy of ?3 months
- •6\. Patients with the following test results prior to treatment
- •1\) Total bilirubin \= 1\.5 x Upper Limit of Normal (Except in the case of Gilbert’s syndrome and when the indirect bilirubinis increased)
- •2\) AST \& ALT \= 3 x Upper Limit of Normal (With the exception of when patient was diagnosed with liver invasion of leukemia)
- •3\) Creatinine clearance (CrCl) \= 30 mL/min (using Cockcroft and Gault’s formula)
- •7\. Patients with their written consent form filled out either by the patient or his/her lawful representative, and can abide to the study requirements prior to the start of clinical trial
Exclusion Criteria
- •1\. Patients with scheduled allogeneic hematopoietic stem cell transplantation during trial period
- •2\. Patients hypersensitive to the components of study drug
- •3\. Patients with active invasion of leukemia to leptomeningeal or central nervous system (CNS)
- •4\. Patients with recent history of major surgery
- •5\. Patients with progression of complication with surgery or wound recovery
- •6\. Patients with hemorrhaging tendency due to reasons other than leukemia or who are being treated with anti\-coagulatory treatment
- •7\. Patients with major complicating disorder or major non\-tumor hepatic disorder (eg, cirrhosis, active chronic hepatitis), or who experienced myocardiac infarction (MI) or unstable angina within 6 months period prior to start of trial, or who has clinically significant heart disease
- •8\. Patients with prior history of major neurological or psychological disorder that could influencepatient adgerencerelated to the evaluation of trial protocol
- •9\. Patients who has uncontrollable infection under progression
- •10\. HIV (human immunodeficiency virus)positive patients
Outcomes
Primary Outcomes
Not specified
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