Treatment of Natural Killer/T Cell Lymphoma-I/II
Conditions
Nasal and Nasal-type NK/T-cell Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, T-Cell
Conditions: Keywords
NK/T cell lymphoma, chemotherapy, clinical trial, RR, PFS, OS
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase) Type: Other
Name: VIPD(cisplatin,Etoposide,Ifosfamide, dexamethasone,Mesna) Type: Other
Name: gemcitabine,pegaspargase,cisplatin,dexamethasone Type: Other
Name: cisplatin,Etoposide,Ifosfamide,dexamethasone,Mesna Type: Other
Name: Radiotherapy Type: Radiation
Overall Status
Recruiting
Summary
The purpose of this study is to evaluate the efficacy and safety of DDGP regiment (gemcitabine,pegaspargase,cisplatin,dexamethasone) for patients with newly diagnosed stage I/II 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 I/II NK/T cell lymphoma.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 14 Years
Gender: Both
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

- patients taking other antitumor drugs

- patients estimated to be unsuitable by investigator
Location
Oncology Department of The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Status: Recruiting
Contact: Mingzhi Zhang, Pro,Dr - 13838565629 - mingzhi_zhang@126.com
Start Date
January 2011
Completion Date
May 2019
Sponsors
Mingzhi Zhang
Source
Zhengzhou University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page