A Randomized Controlled Multi-center Clinical Trial on Treatment of Stage Ⅲ/Ⅳ NK/T Cell Lymphoma With DDGP Regiment (Gemcitabine,Pegaspargase,Cisplatin,Dexamethasone)
Overview
- Phase
- Phase 4
- Intervention
- DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase)
- Conditions
- Nasal and Nasal-type NK/T-cell Lymphoma
- Sponsor
- Mingzhi Zhang
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Progression-free survival
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of DDGP regiment (gemcitabine，pegaspargase,cisplatin,dexamethasone) for patients with stage Ⅲ/Ⅳ Natural Killer (NK)/T Cell Lymphoma.
Detailed Description
Patients with NK/T cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy of CHOP. The investigators have been proceeding this trial to evaluate the efficacy and safety of the combination chemotherapy regiment DDGP (gemcitabine，pegaspargase, cisplatin, dexamethasone) in the patients with stage Ⅲ/Ⅳ NK/T cell lymphoma.
Investigators
Mingzhi Zhang
the director of oncology department of the first affiliated hospital
Zhengzhou University
Eligibility Criteria
Inclusion Criteria
- •Age range 14-70 years old; ECOG performance status 0-2; Estimated survival time \> 3 months
- •Histological confirmed NK/T cell lymphoma
- •None of chemotherapy or radiotherapy has been previously used
- •None of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT and AST ≤ 2×ULN, serum bilirubin ≤ 1.5×ULN, serum creatine ≤ 1.5×upper limitation of normal (ULN), Serum Albumin ≥ 30g/L, serum plasminogen is normal (Inclusion Criteria of 1,3,6 groups )
- •At least one measurable lesion
- •None of other serious diseases, cardiopulmonary function is normal
- •Pregnancy test of women at reproductive age must be negative
- •Patients could be followed up
- •None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments.
- •volunteers who signed informed consent.
Exclusion Criteria
- •Disagreement on blood sample collection
- •Patients allergic of any of drug in this regimen or with metabolic disorder
- •Pregnant or lactating women
- •Serious medical illness likely to interfere with participation
- •Serious infection
- •Primitive or secondary tumors of central nervous system
- •Chemotherapy or radiotherapy contraindication
- •The evidence of CNS metastasis
- •History of peripheral nervous disorder or dysphrenia
- •patients participating in other clinical trials
Arms & Interventions
DDGP regiment
DDGP(gemcitabine,pegaspargase,cisplatin,dexamethasone) regiment
Intervention: DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase)
SMILE Regiment
Modified SMILE （methotrexate，hexadecadrol，Ifosfamide，L-AsparaginaseL，Etoposide，Mesna）Regiment
Intervention: Modified SMILE （MTX，DEX，IFO，L-ASP，Etoposide，Mesna）
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: up to end of follow-up-phase (approximately 24 months)
Secondary Outcomes
- median survival time(24 months)
- response rate(every 6 weeks,up to completion of treatment(approximately 18 weeks ))
- overall survival(up to the date of death (approximately 5 years))