Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

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

• patients taking other antitumor drugs

• patients estimated to be unsuitable by investigator

Trial Contact Information

Trial Lead Organizations/Sponsors

Mingzhi Zhang

Mingzhi Zhang, Pro,Dr

Principal Investigator

Mingzhi Zhang, Pro，Dr		Ph: 13838565629
		Email: mingzhi_zhang@126.com

China
	Zhengzhou
	First Affiliated Hospital of Zhengzhou University
		Mingzhi Zhang, Pro,Dr	Ph: 13838565629
			Email: mingzhi_zhang@126.com
		Mingzhi Zhang, Pro,Dr	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01501136
Information obtained from ClinicalTrials.gov on August 12, 2012

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