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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Stage I/II Extranodal NK/T-cell Lymphoma

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Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Compete response rate

Outcome Time Frame:

Within 3 weeks after the completion fo treatment

Safety Issue:

No

Principal Investigator

Won Seog Kim, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center

Authority:

Korea: Food and Drug Administration

Study ID:

2008-04-033

NCT ID:

NCT01007526

Start Date:

April 2008

Completion Date:

December 2012

Related Keywords:

  • Stage I/II Extranodal NK/T-cell Lymphoma
  • Extranodal Lymphoma
  • Natural killer cell
  • T cell
  • Radiotherapy
  • Chemotherapy
  • Lymphoma
  • Lymphoma, T-Cell

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