NK/T-cell Lymphoma of Nasal Cavity Clinical Trial
Official title:
Open-labeled, Multicenter Phase II Study of Concomitant Chemo-radiotherapy Followed by VIDL Chemotherapy With Risk-based Application of Autologous Stem Cell Transplantation in Stage I/II Extranodal NK/T-cell Lymphoma
This study is to evaluate the efficacy of risk-adapted treatment strategy for stage I/II extranodal NK/T cell lymphoma. The risk stratification is based on the Korean NK prognostic index. Thus, the group I/II will receive concomitant chemoradiation followed by VIDL chemotherapy. The group III/IV will receive high dose-chemotherapy followed by autologous stem cell transplantation after the completion of VIDL chemotherapy.
1. Concomitant chemo-radiotherapy:
Radiotherapy 36-44 Gy/18-22 fractions
+ weekly cisplatin 30 mg/m2 for 4 weeks
2. Rest period: 3 weeks
3. VIDL combination chemotherapy: (total 2 cycles) VP-16 (etoposide) 100mg/m2 I.V. D1-3
Ifosfamide 1.2g/m2 I.V. D1-3 Dexamethasone 40mg/day D1-3 L-asparaginase 4000IU/m2 IM D8,
10, 12, 14, 16, 18, 20 Repeated every 28 days
4. Peripheral blood stem cell mobilization G-CSF 400ug/m2/day or 10ug/kg/day S.C. or I.V.
for 4-6 days followed by stem cell collection (Minimum requirement of CD34+ cells >
2×106/kg)
5. High-dose chemotherapy with autologous stem cell transplantation Busulfex 3.2mg/kg/day
from day -7 to day -5 Etoposide 400mg/m2/day on day -5, -4 Cyclophosphamide 50mg/kg/day
on day -3, -2 Followed by stem cell infusion
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04414969 -
Anti-PD-1 Antibody Combined With Peg-Asparaginase and Chidamide for the Early Stage of NK/T Cell Lymphoma
|
Phase 2 |