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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- NK/T-cell Lymphoma of Nasal Cavity
- Sponsor
- Samsung Medical Center
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Compete Response Rate
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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
Investigators
Won Seog Kim
Professor
Samsung Medical Center
Eligibility Criteria
Inclusion Criteria
- •patients were required to have a biopsy-proven diagnosis of nasal ENKTL
- •at least 18 years old
- •Ann Arbor stage IE or IIE
- •measurable disease
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •life expectancy greater than 12 weeks
- •adequate hematologic (hemoglobin \> 9.0 g/dL, absolute neutrophil count \> 1,500/uL and platelets \> 100,000/uL)
- •renal (serum creatinine \< 1.5 mg/dL, creatinine clearance \> 50 mL/min)
- •hepatic (total bilirubin \< 2 times of upper limit of normal and aspartate transferase \< 3 times of upper limit of normal) function
- •Diagnosis of ENKTL is based on the presence of histological features and immunophenotypes compatible with ENKTL (e.g., cytoplasmic CD3+, CD20-, CD56+, positive for cytotoxic molecules, positive for EBV by in situ hybridization).
Exclusion Criteria
- •prior or concomitant malignant tumors
- •any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.
- •ENKTL with non-nasal sites such as skin or gastrointestinal tract was excluded even if it is localized.
- •Other subtypes of non-Hodgkin lymphoma (NHL), including myeloid/NK cell precursor acute leukemia, blastic NK cell lymphoma/precursor NK cell lymphoblastic leukemia, aggressive NK cell leukemia, and peripheral T cell lymphoma, unspecified, were excluded.
Outcomes
Primary Outcomes
Compete Response Rate
Time Frame: Within 3 weeks after the completion fo treatment
Response was determined by the revised response criteria for malignant lymphoma (Cheson BD et al. J Clin Oncol. 2007 Feb 10;25(5):579-86.): 1) Complete response 2) Partial response 3) Stable disease 4) Progressive disease
Secondary Outcomes
- Overall Response Rate, Survival, Toxicity(Up to 5 years after the completion of treatment)