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

October 21, 2020 updated by: Won Seog Kim, Samsung Medical Center

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Seoul, Korea, Republic of, 135-710
        • Recruiting
        • Samsung Medical Center
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Seokjin Kim, M.D., Ph.D.
        • Principal Investigator:
          • Wonseog Kim, M.D. Ph.D
    • Seoul, Korea, Republic Of
      • Seoul, Seoul, Korea, Republic Of, Korea, Republic of, 135-710
        • Recruiting
        • Samsung Medical Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed extranodal NK/T cell lymphoma
  • Aged between 19 and 65 years
  • Previously untreated history
  • Performance status: Eastern Cooperative Oncology Group 0-2
  • Ann Arbor stage III and IV
  • At least one in positron emission tomograph(PET)/CT positive lesion or in 2-dimensional computerized tomography

    • mass lesions more than 2 cm by conventional CT or more than 1 cm by spiral CT
    • Skin lesions or physically detected mass more than 2 cm
  • Cardiac ejection fraction ≥ 45 % as measured by multiple gated acquisition scan(MUGA) or 2D echogram(ECHO) without clinically significant abnormalities
  • Adequate liver functions: Transaminase (AST/ALT) < 3 X upper normal value(or < 5 x upper limit of normal in the presence of NK/T lymphoma involvement of the liver)
  • Bilirubin < 2 X upper normal value(or < 5 x upper limit of normal in the presence of DLBCL involvement of the liver)
  • Serum Creatinine < 2.0 mg/dL
  • Adequate bone marrow functions: hemoglobin ≥ 9 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 75,000/μL, unless abnormalities are due to bone marrow involvement by lymphoma
  • Expected life is more than 180 days (more than 6 months)
  • A negative serum or urine pregnancy test prior to treatment must be available both for pre-menopausal women and for women who are < 1years after the onset of menopause. Premenopausal women should be treated with appropriate contraception such as hormone contraception, intra-uterine device, spermicidal condom and etc. during and one month after the treatment.
  • Voluntarily signed the informed consent including fully understand of clinical procedures and processing steps for the clinical trial

Exclusion Criteria:

  • Patients who have serious medical condition, abnormal laboratory results or psychiatric problems
  • Other subtypes non-Hodgkin's lymphoma than NK/T cell lymphoma
  • Patients who have aggressive NK/T cell leukemia
  • NK/T cell lymphoma with Primary Central Nervous System (CNS) involvement. However, patients who have only had prophylactic intrathecal chemotherapy against CNS disease are eligible.
  • Patients with a known history of HIV seropositivity or hepatitis C virus (HCV) (+). Patients who have carrier hepatitis B virus (HBV) (+) are eligible. However, primary prophylaxis using antiviral agents is recommended for HBV carrier to prevent HBV reactivation during whole treatment period.
  • Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
  • Pregnant or lactating women, women of childbearing potential not employing adequate contraception
  • Other serious illness or medical conditions i. Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry ii. History of significant neurologic or psychiatric disorders including dementia or seizures iii. Active uncontrolled infection (viral, bacterial or fungal infection) iv. Other serious medical illnesses
  • Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.
  • Serious allergy history for experimental drugs
  • Patients who contraindication to the study drug use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VIDL+ASCT
  1. VIDL Induction (repeated 28 days) : VP-16, Ifosfamide, Dexamethasone, L-asparaginase
  2. Peripheral blood stem cell mobilization:Etoposide
  3. Conditioning regimen for autologous stem cell transplantation:Busulfan,Melphalan,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.
Other Names:
  • VP-16
It will be administered1.2g/m2 + 5% dextrose in water 100 mL intravenous over 1 hr D1-3
It will be administered 40mg/day PO or IV D1-3
It will be administered 4000 IU/m2 intramuscular D8, 10, 12, 14, 16, 18, 20

Conditioning regimen for autologous stem cell transplantation:

Busulfan 3.2 mg/kg D -8, -7, -6

Conditioning regimen for autologous stem cell transplantation:

Melphalan 70 mg/m2 D -3, -2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression-free survival (PFS)
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
objective overall response rate
Time Frame: 2 years
2 years
Number of subjects with Adverse Events as a Measure of safety and tolerability
Time Frame: 2 years
2 years
overall survival
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: won-Seog Kim, MD,Ph.D, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2016

Primary Completion (Anticipated)

August 31, 2021

Study Completion (Anticipated)

November 30, 2021

Study Registration Dates

First Submitted

September 6, 2015

First Submitted That Met QC Criteria

September 6, 2015

First Posted (Estimate)

September 9, 2015

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 21, 2020

Last Verified

October 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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