Status:
UNKNOWN
Treatment of Natural Killer/T Cell Lymphoma-I/II
Lead Sponsor:
Mingzhi Zhang
Collaborating Sponsors:
Second Hospital of Shanxi Medical University
Shanxi Province Cancer Hospital
Conditions:
Nasal and Nasal-type NK/T-cell Lymphoma
Eligibility:
All Genders
14-70 years
Phase:
PHASE4
Brief 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 ...
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 tri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2019
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01501136
Start Date
January 1 2011
End Date
May 1 2019
Last Update
July 17 2015
Active Locations (1)
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1
Oncology Department of The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052