compare efficacy of chop versus fractionated iced in transplant-eligible patients with previously untreated ptcl

Conditions: Peripheral T-cell Lymphoma

Summary: this study is a randomized phase ii study to compare efficacy of chop versus fractionated iced in transplant-eligible patients with previously untreated peripheral t-cell lymphoma.

it recommends that the chop regimen in the primary t-cell lymphoma therapies currently used but did not get satisfactory effect of therapy (progression-free survival 40%), primarily to consider the clinical trial at nccn guideline.but why the chop regimen is widely used because physicians are accustomed to use. fractionated iced therapy is a therapy by adjusting the original ice regimen.this is how the capacity of ifosfamide divided into three days. (fractionated ifosfamide).original ice therapy has been widely used as a salvage therapy of patients with relapsed or refractory lymphoma for a long time, it has been recommended as part of primary therapy of t-cell lymphoma.but fractionated iced is added to dexamethasone therapy in order to improve the effectiveness as a primary therapy.the recurrent lymphoma in 75 patients with treatment after fractionated ice when the self-stem cell transplantation, showed a more than 40% progression-free survival.thus treatment of fractionated iced targeting previously untreated patients, and if a combination of high-dose dexamethasone to expect to be able to induce a progression-free survival of 60% or more.

Eligibility criteria:
inclusion criteria: 1. age 19-65 years 2. informed consent 3. subject able to adhere to the study visit schedule and other protocol requirements. 4. histologically proven peripheral t-cell lymphoma,no prior chemotherapy for the treatment of peripheral t-cell lymphoma it includes the following subtypes. * ptcl, not otherwise specified * angioimmunoblastic t-cell lymphoma * anaplastic large cell lymphoma, alk-negative type * enteropathy-associated t-cell lymphoma * hepato-splenic t-cell lymphoma * subcutaneous panniculitis-like t-cell lymphoma * primary cutaneous gamma-delta t-cell lymphoma * primary cutaneous cd8+ aggressive epidermotropic lymphoma * other non classifiable t-cell lymphoma 5. performance status (ecog) 0,1 or 2 6. a negative pregnancy test prior to treatment must be available both for pre-menopausal women 7. female of childbearing potential (fcbp) must: contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on ip; and for 3 months following the last dose of ip.male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for 3 months following ip discontinuation. 8. life expectancy≥90day(3months) exclusion criteria: 1. other serious medical illnesses or psychiatric disorders 2. any state that the confusion in the interpretation of test result. 3. other type lymphoma ex) b-cell lymphoma 4. other type t-cell lymphoma * adult t-cell leukemia/lymphoma * nk/t-cell lymphoma, nasal type * alk-positive anaplastic large-cell lymphoma * cutaneous tcell lymphoma * primary cutaneous cd30+ lympho- proliferative disorder * primary cutaneous anaplastic t cell lymphoma 5. previously treated for ptcl(except for a short period before randomization of corticosteroids (a period of not more than 8 days) 6. previous radiation therapy 7. cns involvement. 8. if the contraindication to chemoherapy 9. subject has known historical or active infection with hiv. 10. bm function: anc \ 2 x upper normal value 11. serum creatinine level \> 2.0 x uln 12. any other malignancies within the past 3 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri 13. muga scan \<45% 14. those who administered doxorubicin exceeding 200 mg / m2 15. subject has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy. 16. breast-feeding or pregnant female