Concomitant Chemo-radiotherapy Plus VIDL Chemotherapy in NK/T-cell Lymphoma
Conditions
Stage I/II Extranodal NK/T-cell Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, Extranodal NK-T-Cell - Lymphoma, T-Cell
Conditions: Keywords
Extranodal Lymphoma, Natural killer cell, T cell, Radiotherapy, Chemotherapy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: concomitant chemo-radiotherapy followed by VIDL chemotherapy with risk-based application of autologous stem cell transplantation
Type: Other
Overall Status
Recruiting
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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).

- Informed consent

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.
Location
Samsung Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Start Date
April 2008
Completion Date
December 2012
Sponsors
Samsung Medical Center
Source
Samsung Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page