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

NCT02544425 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2020-10-22

No results posted yet for this study

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.

Conditions

  • Extranodal NK-T-Cell Lymphoma

Interventions

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

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • won-Seog Kim, MD,Ph.D · Samsung Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-21
Primary Completion
2021-08-31
Completion
2021-11-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02544425 on ClinicalTrials.gov