NCT02544425

VP-16, Ifosfamide, Dexamethasone, L-asparaginase Chemotherapy in Patients With Extranodal Natural Killer T Cell Lymphoma (VIDL+ASCT)

Phase II Study of VIDL (VP-16, Ifosfamide, Dexamethasone, L-asparaginase) Chemotherapy Followed by High-dose Chemotherapy and Autologous Stem Cell Transplantation in Patients With Stage III/IV Extranodal NK-T-Cell Lymphoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Open-labeled, multicenter phase II study of VIDL (VP-16, Ifosfamide, Dexamethasone, L-asparaginase) chemotherapy followed by high-dose chemotherapy and autologous stem cell transplantation in patients with stage III/IV extranodal NK/T-cell Lymphoma.

Detailed description

Extranodal NK/T cell lymphoma (ENKTL) is a rare and aggressive lymphoma subtype, but standard front-line therapy has not been established. The clinical outcome of patients (pts) with ENKTL after the treatment of conventional chemotherapy, especially pts with advanced stage, was generally poor. Therefore, high-dose chemotherapy followed by autologous stem cell transplantation (ASCT) as a consolidation could be one of promising strategies to improve the outcome of ENKTL. However, there have been few studies reporting the survival outcome or prognostic significances of front-line ASCT in pts with ENKTL. Thus, the aim of this study was to investigate the outcome of patients with advanced-stage ENKTL who had undergone front-line ASCT.

Conditions

• Extranodal NK-T-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Etoposide	Subjects will receive Etoposide 100 mg/m2 + 5% dextrose in water 500 mL intravenous over 90 mins D1-3 of VIDL chemotherapy. After that, Etoposide will be administered 375mg/m2 D1-2 with G-colony stimulating factor (10 ug/kg) injection in step of Peripheral Blood Stem Cell Collection. Also It will be administered 400mg/m2 on conditioning regimen.
DRUG	Ifosfamide	It will be administered1.2g/m2 + 5% dextrose in water 100 mL intravenous over 1 hr D1-3
DRUG	Dexamethasone	It will be administered 40mg/day PO or IV D1-3
DRUG	L-asparaginase	It will be administered 4000 IU/m2 intramuscular D8, 10, 12, 14, 16, 18, 20
DRUG	Busulfan	Conditioning regimen for autologous stem cell transplantation: Busulfan 3.2 mg/kg D -8, -7, -6
DRUG	Melphalan	Conditioning regimen for autologous stem cell transplantation: Melphalan 70 mg/m2 D -3, -2

Timeline

• Start date: 2016-02-21
• Primary completion: 2021-08-31
• Completion: 2021-11-30
• First posted: 2015-09-09
• Last updated: 2020-10-22

Locations

2 sites across 1 country: South Korea