Treatment of Natural Killer/T Cell Lymphoma-Ⅲ/Ⅳ

• Status: Unknown status
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mingzhi Zhang
• Collaborators: Cancer Hospital of Guizhou Province; Qingdao University; Second Hospital of Shanxi Medical University; Shanxi Province Cancer Hospital; The First Affiliated Hospital of Henan University of Traditional Chinese Medicine; Wuhan TongJi Hospital; Wuhan Union Hospital, China; Wuhan University; Xinyang Central Hospital
• Treatments: Asparaginase; BB 1101; Cisplatin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Etoposide; Etoposide phosphate; Gemcitabine; Mesna; Pegaspargase

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