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

NCT01007526 | Completed Phase 2 Results

• 1 other identifier: 2008-04-033
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

NK/T-cell Lymphoma of Nasal Cavity

Keywords

Extranodal Lymphoma; Natural killer cell; T cell; Radiotherapy; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall Response Rate, Survival, Toxicity

  Up to 5 years after the completion of treatment

Study Arms (1)

CCRT plus VIDL

EXPERIMENTAL

CCRT followed by VIDL chemotherapy Concomitant chemo-radiotherapy followed by VIDL chemotherapy with risk-based application of autologous stem cell transplantation Patients who are planned to be treated with CCRT plus VIDL chemotherapy and/or autologous stem cell transplantation

Other: CCRT followed by VIDL chemotherapy

Interventions

CCRT followed by VIDL chemotherapy OTHER

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

CCRT plus VIDL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead
• Asan Medical Center: collaborator
• National Cancer Center, Korea: collaborator
• Severance Hospital: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Results Point of Contact

• Title: Won Seog Kim
• Organization: Samsung Medical Center

wskimsmc@skku.edu

82234106548

Study Officials

• Won Seog Kim, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Concomitant Chemo-radiotherapy Plus VIDL Chemotherapy
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: VIDL (Etoposide, ifosfamide, dexamethasone and L-asparaginase)

Study Record Dates

• First Submitted: November 2, 2009
• First Posted: November 4, 2009
• Study Start: April 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 7, 2019
• Results First Posted: February 7, 2019

Record last verified: 2018-09

Locations

KR (1)