Concomitant Chemo-radiotherapy Followed by MIDLE Chemotherapy in Stage I/II Extranodal NK/T-cell Lymphoma

Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01238159
• Other study ID #: 2010-06-019
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2010
• Last updated: March 1, 2015
• Start date: August 2010
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of concomitant chemoradiation followed by MIDLE chemotherapy for stage I/II extranodal NK/T cell lymphoma.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type
• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, T-Cell

Intervention

Radiation:
• CCRT+MIDLE chemotherapy
Patients are planned to be treated with CCRT plus MIDLE chemotherapy

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (5)

Lead Sponsor	Collaborator
Samsung Medical Center	Asan Medical Center, Chonnam National University, Seoul National University, Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response	The response criteria was based on the International Working Group Report (1999).	Within 4 weeks after the completion of planned treatment	No
Secondary	Overall response rate	Overall response rate includes complete and partial response.	Up to 2 years	Yes
Secondary	overall survival	Overall survival is defined as the time interval between the date of diagnosis and the date of death with any cause.	up to 2 years	Yes
Secondary	Progression-free survival	Progression-free survival is defined as the time interval between the the date of diagnosis and the date of death with any cause or disease progression/relapse.	up to 2 years	Yes