None listed
Conditions
Interventions
Drug, Biological/Vaccine, Non-Stem Cell : 1. name: DNP001
2. starting dose: 0.1mg/kg (only first subjet is 0.01 plus 0.09mg/kg)
3. escalating dose:1, 2, 4, 8, 16 mg/ kg
4. administration route: IV
5
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion 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
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 11. Women who are pregnant or breastfeeding, or fertile men or women who did ont consent to effective contraceptive method during or after the treatment up to 6 months 12. Patients who were administered with biologics including hematopoietic growth factor within 1 week period prior to start of trial 13. Patients with evidence of rapid proliferating disease treated with other study drug within 5 times the half-life period prior to be selected for trial, or if half-life is not known within 30 days of treatment 14. Patients with other relate disease or adverse clinical symptom who are deemed inappropriate to participate in the clinical study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Limiting Toxicity;Maximum Tolerated Dose(MTD);Adverse event | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy evaluation;PharmacoKinetics evaluation;PharmacoDynamics evaluation | — |
Countries
Korea, Republic of
Contacts
Public ContactJe-Hwan Lee
Asan Medical Center
Outcome results
None listed