Open-labeled, multicenter phase II study of VIDL (VP-16, Ifosfamide, Dexamethasone, L-asparaginase) chemotherapy followed by high-dose chemotherapy and autologous stem cell transplantation in patients with stage III/IV extranodal NK/T-cell Lymphoma.
Extranodal NK/T cell lymphoma (ENKTL) is a rare and aggressive lymphoma subtype, but standard front-line therapy has not been established. The clinical outcome of patients (pts) with ENKTL after the treatment of conventional chemotherapy, especially pts with advanced stage, was generally poor. Therefore, high-dose chemotherapy followed by autologous stem cell transplantation (ASCT) as a consolidation could be one of promising strategies to improve the outcome of ENKTL. However, there have been few studies reporting the survival outcome or prognostic significances of front-line ASCT in pts with ENKTL. Thus, the aim of this study was to investigate the outcome of patients with advanced-stage ENKTL who had undergone front-line ASCT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Subjects will receive Etoposide 100 mg/m2 + 5% dextrose in water 500 mL intravenous over 90 mins D1-3 of VIDL chemotherapy. After that, Etoposide will be administered 375mg/m2 D1-2 with G-colony stimulating factor (10 ug/kg) injection in step of Peripheral Blood Stem Cell Collection. Also It will be administered 400mg/m2 on conditioning regimen.
It will be administered1.2g/m2 + 5% dextrose in water 100 mL intravenous over 1 hr D1-3
It will be administered 40mg/day PO or IV D1-3
Samsung Medical Center
Seoul, Seoul, Korea, Republic of, South Korea
RECRUITINGSamsung Medical Center
Seoul, South Korea
RECRUITINGprogression-free survival (PFS)
Time frame: 2 years
objective overall response rate
Time frame: 2 years
Number of subjects with Adverse Events as a Measure of safety and tolerability
Time frame: 2 years
overall survival
Time frame: 4 years
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It will be administered 4000 IU/m2 intramuscular D8, 10, 12, 14, 16, 18, 20
Conditioning regimen for autologous stem cell transplantation: Busulfan 3.2 mg/kg D -8, -7, -6
Conditioning regimen for autologous stem cell transplantation: Melphalan 70 mg/m2 D -3, -2