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Open-labeled, Multicenter Phase II Study of Concomitant Chemo-radiotherapy Followed by MIDLE (Methotrexate, Ifosfamide, Dexamethasone, L-asparaginase, Etoposide) Chemotherapy in Stage I/II Extranodal NK/T-cell Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type

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Trial Information

Open-labeled, Multicenter Phase II Study of Concomitant Chemo-radiotherapy Followed by MIDLE (Methotrexate, Ifosfamide, Dexamethasone, L-asparaginase, Etoposide) Chemotherapy in Stage I/II Extranodal NK/T-cell Lymphoma


Concomitant chemo-radiotherapy:

Radiation 36-44 Gy/18-22 fractions (2 Gy/fraction) Weekly Cisplatin 30mg/m2 + N/S 100ml MIV
over 30min Tri-weekly L-asparaginase 4000 IU IV (D1, 3, 5)

Rest period: 3 weeks

MIDLE chemotherapy: Repeated every 28 days for 2 cycles D1 Methotrexate 3g/m2 + D5W 500ml
MIV over 6 hours D2-D3 Etoposide 100mg/m2 + D5W 500ml MIV over 90mins D2-D3 Ifosfamide
1000mg/m2 + D5W 100ml MIV over 1hr D2-D3 Mesna 300mg/m2 + D5W 100ml MIV over 15mins (-15min,
4hrs and 8hrs after ifosfamide, total 3 doses) D1-D4 Dexamethasone 40mg/d PO or IV D4, 6, 8,
14, 10 L-asparaginase 6000IU/m2 + D5W 500ml MIV over 2hours


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:

Complete response

Outcome Description:

The response criteria was based on the International Working Group Report (1999).

Outcome Time Frame:

Within 4 weeks after the completion of planned treatment

Safety Issue:

No

Principal Investigator

Won Seog Kim, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center

Authority:

Korea: Institutional Review Board

Study ID:

2010-06-019

NCT ID:

NCT01238159

Start Date:

August 2010

Completion Date:

December 2013

Related Keywords:

  • Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type
  • Natural killer cell
  • T cell
  • Lymphoma
  • Radiation
  • Chemotherapy
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, Extranodal NK-T-Cell

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