Concomitant Chemo-radiotherapy Plus VIDL Chemotherapy in NK/T-cell Lymphoma

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

Intervention(s) in this Clinical Trial

• Other: concomitant chemo-radiotherapy followed by VIDL chemotherapy with risk-based application of autologous stem cell transplantation
  • concomitant chemo-radiotherapy followed by VIDL (VP-16, Ifosfamide, Dexamethasone, L-asparaginase) chemotherapy with risk-based application of autologous stem cell transplantation

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Patients who are planned to be treated with CCRT plus VIDL chemotherapy and/or autologous stem cell transplantation

Primary Measures

• Compete response rate
  • Time Frame: Within 3 weeks after the completion fo treatment
    Safety Issue?: No

Secondary Measures

• Overall response rate, survival, toxicity
  • Time Frame: Up to 5 years after the completion of treatment
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Samsung Medical Center Other

Overall Clinical Trial Officials and Contacts

Won Seog Kim, MD, PhD Principal Investigator Samsung Medical Center  

Overall Contact: Won Seog Kim, MD, PhD 82234106548 wskimsmc@skku.edu

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01007526

Study ID Number: 2008-04-033

ClinicalTrials.gov Identifier: NCT01007526

Health Authority: Korea: Food and Drug Administration