None listed
Conditions
Interventions
Drug : A. Test group : Decitabine + Gemcitabine + Oxaliplatin + Dulastin dosing group
Gemcitabine 1,000 mg/m2 miv over 100 minutes (mixed with normal saline 150 ml) D1, D8
Oxaliplatin 100 mg/m2 miv ov
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients who diagnosed Peripheral T cell lymphoma by pathologically and recurred after receiving the primary chemotherapy or have experienced disease progression without responding the primary chemotherapy. (2) Age more than 19 years old (3) ECOG performance status = 2 (4) Patients with adequate bone marrow function : White blood cells = 3,000/uL Absolute neutrophil counts = 2,000/uL Platelets = 75,000/uL Hemoglobin = 8.0 g/dL : Blood transfustion within 1 week of screening is not allowed. (5) Patients with adequate kidney fuction : serum creatinine = 1.5 times the upper limit of normal (ULN) (6) Patients with adequate liver fuction : serum total bilirubin = 1.5 times the upper limit of normal (ULN) AST (SGOT) ? ALT (SGPT)= 2.5 X ULN or In case of the subject has liver metastasis, = 5 X ULN : It is allowed to participate in study by physician decision, when liver failure is deemed to be caused by disease. (7) Patients with measurable disease (8) Patients who understand the description and give written informed consent (9) Willingness and ability to comply with visit schedules, treatment plans, laboratory assessments in trial and other study procedures. (10) hCG test result should be negative for female subjects of child-bearing potential (within 3 weeks of administration). (11) Patients who can observe contraception using efficient contraceptive method(Barrier mothod) within 4 weeks of enroll in study and throughout the study period.
Exclusion criteria
Exclusion criteria: (1) Patients who have been diagnosed with other malignant diseases other than lymphoma in the last three years. (2) In case of 3rd or more anti-cancer chemotherapy is performed for lymphoma (However, if an autologous hematopoietic stem cell transplantation is performed, the autologous hematopoietic stem cell transplantation is considered as part of one treatment.) (3) Evidence of uncontrolled central nerve system involvement (4) Patients is known to have congenital immune disease or human immunodeficiency virus infection. (5) Patients who have received an organ transplant(including allogenic bone marrow transplant). (6) In case of uncontrolled convulsion or psychiatric disorders (7) Female subjects who is pregnant or brest-feeding (8) In case a inverstigator judges another serious illness or medical condition (9) Peripheral neuropathy above the grade III (10) Patients who have not passed more than 2 weeks since the last chemotherapy (11) Patients who executed chemotherapy for lymphoma including Gemcitabine. (12) Patients has known history of HIV or an uncontrolled infection(Bacterial, viral or fungal) (13) Patient has had surgery within 14 days prior to the study erollment: In case of failure to recover from post-operative complications cannot be erolled in study even if the patient undergone surgery before 14 days. (14) HBV positive patient: HbsAg positive patient cannot be enrolled, and HbcAb positive patient must be verified as HBV negative through PCR test. In case of anti-HBc positive patient enrolled, effective anti-HBV prophylaxis shoudl be implemented. (15) Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded (16) Known history of drug-specific hypersensitivity or anaphylaxis to study drug (including active product or excipient components). (17) Patients with a history of hypersensitivity reaction to Decitabine, Gemcitabine, Oxaliplatin and other platinum agents (18) epileptic pneumonia or pulmonary fibrosis patients with clear chest x-ray images and clinical symptoms (19) The patient who undergoing radiotherapy for the chest (20) Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| complete response rate;time to response;progression free survival;overall survival;adverse drug reaction;neurotoxicity;hematologic response rate | — |
Countries
Korea, Republic of
Contacts
Public ContactSung-Soo Yoon
Seoul National University Hospital
Outcome results
None listed