None listed
Conditions
Interventions
Drug : Patients will be administered orally 10mg/day(5.0 mg prior to breakfast + 5.0 mg prior to dinner) of kominox before food intake.
Duration of treatment is 2cycles. (1cycle=28days) No wash-out pe
Sponsors
Komipharm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Non-Hodgkin’s lymphoma confirmed histologically or cytologically 2) Patients who did not achieve a complete remission with second-line chemotherapy or who relapse after chemotherapy. (However, patients who is not the subject of the secondary chemotherapy after primary chemotherapy can participate) 3) Patients who is unsuited or failed to high dose chemotherapy or stem cell transplantation 4) Age over 20 years 5) ECOG performance status = 2 6) At least one unidimensionally measurable lesion 7) Adequate hematological, hepatic, and renal functions were required : - ANC =1500/mm3, Platelets =75,000/mm3 - Nomal serum creatinine range or CCr =60ml/min (by Cockcroft-Gault equation) - Normal serum electrolytes (including calcium, magnesium, phosphorus, potassium) calcium: 8.3~10.5mg/dl, magnesium: 1.58~3.0mg/dl, phosphorus: 2.4~4.5mg/dl, potassium: 3.3~5.5mmol/L - Serum bilirubin <2? upper normal limit (ULN), AST/ALT <2.5?ULN, ALP <5?ULN 8) Corrected QT interval < 0.48 sec 9) Informed consent given in written form after being provided with detailed information about the nature, risks and scope of the clinical trial as well as the expected desirable and adverse effects of the drug
Exclusion criteria
Exclusion criteria: 1) Central nervous system involvement or testicular involvement of non-Hodgkin’s lymphoma 2) History of major gastrointestinal surgery or pathology likely to influence absorption of the study medication 3) Patients previously treated with arsenic compounds 4) Active infection requiring treatment with parenteral antibiotics within 7 day) (Exception : topical antibiotics) 5) Any concomitant other cancer type (exception: basal cell carcinoma or in situ uterine cervical cancer or papillary thyroid cancer patients within 5 years before participation in clinical) 6) =Grade 2 peripheral neuropathy patients 7) Known history of increased risk for torsade de pointes (TdP) like hypokalemia, family history of Long-QT syndrome 8) Myocardial infarction within 6 months before participation in this clinical study, New York Heart Association criteria (NYHA) class 3 or 4 of congestive heart failure, uncontrolled hypertension (diastolic BP >100 or uncontrolled hypertention and unstable angina of systolic >180 or cardiomyopathy and arrhythmia of ejection fraction) 9) Pregnant or lactating women 10) Patients who don’t agree on contraception. 11) Patients with uncontrolled chronic diseases (e.g. chronic hepatitis, Chronic kidney disease, uncontrolled diabetes) 12) Participation in another clinical trials 13) Known hypersensitivity to any of the active or inactive components of the final product 14) HIV positive patients 15) Patients who take drugs that have been reported to cause the QT prolongation and/or torsades de pointes (e.g. Indapamide, Dobutamine, Amiodarone, Ibutilide etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR(%);Safety parameters consisted of adverse events (AE) and laboratory data. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS), Progression free survival (PFS) | — |
Countries
Korea, Republic of
Contacts
Public ContactYangmi Yeo
Hanyang University Seoul Hospital
Outcome results
None listed