- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02544425
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
Status
Unknown
Conditions
Intervention / Treatment
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
- Name: won-Seog Kim, MD,Ph.D.
- Phone Number: 82 2-3410-6548
- Email: wonseog.kim@samsung.com
Study Contact Backup
- Name: Seok-Jin Kim, MD,Ph.D.
- Phone Number: 82 2-3410-1766
- Email: seokjin88.kim@samsung.com
Study Locations
-
-
-
Seoul, Korea, Republic of, 135-710
- Recruiting
- Samsung Medical Center
-
Contact:
- Wonseog Kim, M.D., Ph.D.
- Phone Number: 82-2-3410-6548
- Email: wonseog.kim@samsung.com
-
Contact:
- Seokjin Kim, M.D., Ph.D.
- Email: seokjin88.kim@samsung.com
-
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:
- WonSeog Kim, M.D, Ph. D
- Phone Number: 82 234106548
- Email: wskimsmc@skku.edu
-
Contact:
- SeokJin Kim, M.D,Ph. D
- Phone Number: 82 234101766
- Email: seokjin88.kim@samsung.com
-
-
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
|
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:
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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
- Lymphoma, Extranodal NK-T-Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Dexamethasone
- Etoposide
- Ifosfamide
- Melphalan
- Asparaginase
- Busulfan
Other Study ID Numbers
- 2015-05-035
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
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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