Extranodal NK-T-Cell LymphomaPhase 2VIDL+ASCTNCT02544425
VP-16, Ifosfamide, Dexamethasone, L-asparaginase Chemotherapy in Patients With Extranodal Natural Killer T Cell Lymphoma (VIDL+ASCT)
A Phase 2 study testing Etoposide, Ifosfamide and Dexamethasone in people with Extranodal NK-T-Cell Lymphoma, run by Samsung Medical Center at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Extranodal NK-T-Cell Lymphoma
- What is being tested?
- Etoposide, Ifosfamide and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 21 Feb 2016to 30 Nov 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Samsung Medical Center
Seoul, Seoul, Korea, Republic of, 135-710
WonSeog Kim, M.D, Ph. D, 234106548 ext. 82, wskimsmc@skku.edu
SeokJin Kim, M.D,Ph. D, 234101766 ext. 82, seokjin88.kim@samsung.com
- Recruiting
Samsung Medical Center
Seoul, 135-710
Wonseog Kim, M.D., Ph.D., 82-2-3410-6548, wonseog.kim@samsung.com
Seokjin Kim, M.D., Ph.D., seokjin88.kim@samsung.com
About this study
Official title: 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.
Read the 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
- Being tested
- Etoposide, Ifosfamide, Dexamethasone, L-asparaginase, Busulfan
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtoposideDrug
Also called VP-16
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.
IfosfamideDrug
It will be administered1.2g/m2 + 5% dextrose in water 100 mL intravenous over 1 hr D1-3
DexamethasoneDrug
It will be administered 40mg/day PO or IV D1-3
L-asparaginaseDrug
It will be administered 4000 IU/m2 intramuscular D8, 10, 12, 14, 16, 18, 20
BusulfanDrug
Conditioning regimen for autologous stem cell transplantation:
Busulfan 3.2 mg/kg D -8, -7, -6
MelphalanDrug
Conditioning regimen for autologous stem cell transplantation:
Melphalan 70 mg/m2 D -3, -2
| Study group | Role | What they receive |
|---|---|---|
| VIDL+ASCT | Experimental | 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 Receives: Drug: Etoposide; Drug: Ifosfamide; Drug: Dexamethasone; Drug: L-asparaginase; Drug: Busulfan; Drug: Melphalan |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival (PFS)
Measured: 2 years
Secondary outcomes (3)
objective overall response rate
Measured: 2 years
Number of subjects with Adverse Events as a Measure of safety and tolerability
Measured: 2 years
overall survival
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study start21 Feb 2016
- Primary completion31 Aug 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extranodal NK-T-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Seog Kim, Samsung Medical Center
- Investigators
- won-Seog Kim, MD,Ph.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544425
- Sponsor's protocol ID
- 2015-05-035
- Acronym
- VIDL+ASCT
- Status last verified
- Oct 2020
- First submitted
- 6 Sep 2015
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02544425
- Acronym / sponsor ID
- VIDL+ASCT / 2015-05-035
- Conditions
- Extranodal NK-T-Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 21 Feb 2016 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 9 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VIDL+ASCT | Experimental | Drug: Etoposide, Drug: Ifosfamide, Drug: Dexamethasone, Drug: L-asparaginase, Drug: Busulfan, Drug: Melphalan1. 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 |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtoposideAlso: VP-16Subjects 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 | VIDL+ASCT |
| IfosfamideIt will be administered1.2g/m2 + 5% dextrose in water 100 mL intravenous over 1 hr D1-3 | Drug | VIDL+ASCT |
| DexamethasoneIt will be administered 40mg/day PO or IV D1-3 | Drug | VIDL+ASCT |
| L-asparaginaseIt will be administered 4000 IU/m2 intramuscular D8, 10, 12, 14, 16, 18, 20 | Drug | VIDL+ASCT |
| BusulfanConditioning regimen for autologous stem cell transplantation: Busulfan 3.2 mg/kg D -8, -7, -6 | Drug | VIDL+ASCT |
| MelphalanConditioning regimen for autologous stem cell transplantation: Melphalan 70 mg/m2 D -3, -2 | Drug | VIDL+ASCT |
Primary outcome
progression-free survival (PFS)
Time frame: 2 years
3 secondary outcomes
objective overall response rate
Time frame: 2 years
Number of subjects with Adverse Events as a Measure of safety and tolerability
Time frame: 2 years
overall survival
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
won-Seog Kim, MD,Ph.D principal investigator
Samsung Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Etoposide, Ifosfamide and Dexamethasone in people with Extranodal NK-T-Cell Lymphoma, run by Samsung Medical Center at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact won-Seog Kim, MD,Ph.D. (2-3410-6548 ext. 82, wonseog.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (PFS) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.