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

  • STATUS
    Recruiting
  • End date
    Nov 30, 2021
  • participants needed
    27
  • sponsor
    Samsung Medical Center
Updated on 26 January 2021
platelet count
stem cell transplantation
ejection fraction
etoposide
dexamethasone
neutrophil count

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.

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.

Details
Condition Angiocentric T-cell lymphoma, T-Cell Lymphoma, extranodal nk/t-cell lymphoma
Treatment etoposide, busulfan, ifosfamide, melphalan, Dexamethasone, L-asparaginase
Clinical Study IdentifierNCT02544425
SponsorSamsung Medical Center
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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/L and platelet count 75,000/L, 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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note