Phase 2 N=31 Treatment

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

NK/T-cell Lymphoma of Nasal Cavity

Bottom Line

View on ClinicalTrials.gov: NCT01007526 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2019

Primary outcome: Primary: Compete Response Rate — 31 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: CCRT followed by VIDL chemotherapy (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Samsung Medical Center
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Compete Response Rate	31	—
SECONDARY Overall Response Rate, Survival, Toxicity	—	—

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.

Eligibility Criteria

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01007526). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.