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

NK/T-cell Lymphoma of Nasal Cavity Clinical Trial

— CCRT-VIDL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01007526
• Other study ID #: 2008-04-033
• Status: Completed
• Phase: Phase 2
• Start date: April 2008
• Est. completion date: December 2012

Study information

• Verified date: September 2018
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• 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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• NK/T-cell Lymphoma of Nasal Cavity

Intervention

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

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
Samsung Medical Center	Asan Medical Center, National Cancer Center, Korea, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compete Response Rate	Response was determined by the revised response criteria for malignant lymphoma (Cheson BD et al. J Clin Oncol. 2007 Feb 10;25(5):579-86.): 1) Complete response 2) Partial response 3) Stable disease 4) Progressive disease	Within 3 weeks after the completion fo treatment
Secondary	Overall Response Rate, Survival, Toxicity		Up to 5 years after the completion of treatment