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A Randomized Controlled Multi-center Clinical Trial on Treatment of Stage I/II NK/T Cell Lymphoma With DDGP Regiment (Gemcitabine,Pegaspargase,Cisplatin,Dexamethasone)

Phase 4
14 Years
70 Years
Open (Enrolling)
Nasal and Nasal-type NK/T-cell Lymphoma

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Trial Information

A Randomized Controlled Multi-center Clinical Trial on Treatment of Stage I/II NK/T Cell Lymphoma With DDGP Regiment (Gemcitabine,Pegaspargase,Cisplatin,Dexamethasone)

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.

Inclusion Criteria:

- Age range 14-70 years old; ECOG performance status 0-2; Estimated survival time > 3

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

up to end of follow-up-phase (approximately 24 months)

Safety Issue:


Principal Investigator

Mingzhi Zhang, Pro,Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

The First Affiliated Hospital of Zhengzhou University


China: Food and Drug Administration

Study ID:




Start Date:

January 2011

Completion Date:

May 2019

Related Keywords:

  • Nasal and Nasal-type NK/T-cell Lymphoma
  • NK/T cell lymphoma
  • chemotherapy
  • clinical trial
  • RR
  • PFS
  • OS
  • Lymphoma
  • Lymphoma, T-Cell