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

NCT02544425 | Unknown Phase 2

• 1 other identifier: 2015-05-035
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• progression-free survival (PFS)

  2 years

Secondary Outcomes (3)

• objective overall response rate

  2 years

• Number of subjects with Adverse Events as a Measure of safety and tolerability

  2 years

• overall survival

  4 years

Study Arms (1)

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

Drug: Etoposide; Drug: Ifosfamide; Drug: Dexamethasone; Drug: L-asparaginase; Drug: Busulfan; Drug: Melphalan

Interventions

Etoposide DRUG

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.

Also known as: VP-16

VIDL+ASCT

Ifosfamide DRUG

It will be administered1.2g/m2 + 5% dextrose in water 100 mL intravenous over 1 hr D1-3

VIDL+ASCT

Dexamethasone DRUG

It will be administered 40mg/day PO or IV D1-3

VIDL+ASCT

L-asparaginase DRUG

It will be administered 4000 IU/m2 intramuscular D8, 10, 12, 14, 16, 18, 20

VIDL+ASCT

Busulfan DRUG

Conditioning regimen for autologous stem cell transplantation: Busulfan 3.2 mg/kg D -8, -7, -6

VIDL+ASCT

Melphalan DRUG

Conditioning regimen for autologous stem cell transplantation: Melphalan 70 mg/m2 D -3, -2

VIDL+ASCT

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (2)

Samsung Medical Center

Seoul, Seoul, Korea, Republic of, 135-710, South Korea

RECRUITING

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

Etoposide; Ifosfamide; Dexamethasone; Asparaginase; Busulfan; Melphalan

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Butylene Glycols; Glycols; Alcohols; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• won-Seog Kim, MD,Ph.D

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

won-Seog Kim, MD,Ph.D.

CONTACT

2-3410-6548; wonseog.kim@samsung.com

Seok-Jin Kim, MD,Ph.D.

CONTACT

2-3410-1766; seokjin88.kim@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 6, 2015
• First Posted: September 9, 2015
• Study Start: February 21, 2016
• Primary Completion: August 31, 2021
• Study Completion: November 30, 2021
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

KR (2)