CTTNKTL-Ⅲ/Ⅳ: Treatment of Natural Killer/T Cell Lymphoma-Ⅲ/Ⅳ
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 Ⅲ/Ⅳ NK/T cell lymphoma.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DDGP regiment DDGP(gemcitabine,pegaspargase,cisplatin,dexamethasone) regiment |
Drug: DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase)
DDP 20 mg/m2,ivgtt（intravenously guttae）,d1-4;DEX 15mg/m2,ivgtt,d1-5;GEM 800mg/m2,ivgtt,30min,d1,8;Pegasparaginase,im,2500IU/m2 d1.Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles.
Other Names:
|
| Experimental: SMILE Regiment Modified SMILE （methotrexate，hexadecadrol，Ifosfamide，L-AsparaginaseL，Etoposide，Mesna）Regiment |
Drug: Modified SMILE （MTX，DEX，IFO，L-ASP，Etoposide，Mesna）
MTX,2g/m2 (20% ivgtt（intravenously guttae）,2h;80% ivgtt,4h), d1;DEX,40mg,ivgtt,d2-4;IFO,1.5g/m2,ivgtt,d2-4;L-ASP,6000U/m2,ivgtt,d3-9;VP-16,100mg/m2,ivgtt,d2-4; Mesna,0、4、8h after IFO, 240mg/m2,iv,d2-4.Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Progression-free survival [up to end of follow-up-phase (approximately 24 months)]
Secondary Outcome Measures
- response rate [every 6 weeks,up to completion of treatment(approximately 18 weeks )]
21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles.
- overall survival [up to the date of death (approximately 5 years)]
- median survival time [24 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age range 14-70 years old; ECOG performance status 0-2; Estimated survival time > 3 months
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Histological confirmed NK/T cell lymphoma
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None of chemotherapy or radiotherapy has been previously used
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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 )
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At least one measurable lesion
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None of other serious diseases, cardiopulmonary function is normal
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Pregnancy test of women at reproductive age must be negative
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Patients could be followed up
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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
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Patients allergic of any of drug in this regimen or with metabolic disorder
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Pregnant or lactating women
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Serious medical illness likely to interfere with participation
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Serious infection
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Primitive or secondary tumors of central nervous system
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Chemotherapy or radiotherapy contraindication
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The evidence of CNS metastasis
-
History of peripheral nervous disorder or dysphrenia
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patients participating in other clinical trials
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patients taking other antitumor drugs
-
patients estimated to be unsuitable by investigator
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oncology Department of The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China | 450052 |
Sponsors and Collaborators
- Mingzhi Zhang
- Second Hospital of Shanxi Medical University
- Shanxi Province Cancer Hospital
- Wuhan University
- Wuhan TongJi Hospital
- Wuhan Union Hospital, China
- Qingdao University
- Cancer Hospital of Guizhou Province
- Xinyang Central Hospital
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Investigators
- Principal Investigator: Mingzhi Zhang, Pro，Dr, The First Affiliated Hospital of Zhengzhou University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- hnslblzlzx2011-2