NCT01501136

Treatment of Natural Killer/T Cell Lymphoma-I/II

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Mingzhi Zhang · Academic / Other
• Sex: All
• Age: 14 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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 I/II NK/T cell lymphoma.

Conditions

• Nasal and Nasal-type NK/T-cell Lymphoma

Interventions

Type	Name	Description
OTHER	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. Completion of chemotherapy is followed by radiotherapy 50Gy.Efficacy was evaluated every two cycles.
OTHER	VIPD（cisplatin，Etoposide，Ifosfamide， dexamethasone，Mesna）	DDP,33mg/m2,ivgtt（intravenously guttae）,d1-3；VP-16,100mg/m2,ivgtt,d1-3；IFO,1.2g/m2,ivgtt,d1-3；DEX,40mg,ivgtt,d1-4；Mesna,0、4、8h after IFO,240mg/m2,iv,d1-3.Every 21 days for one cycle and three cycles are required. Completion of chemotherapy is followed by radiotherapy 50Gy.Efficacy was evaluated every two cycles.
OTHER	gemcitabine,pegaspargase,cisplatin,dexamethasone	Radiotherapy 50Gy is followed by chemotherapy(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	cisplatin,Etoposide,Ifosfamide,dexamethasone,Mesna	Radiotherapy 50Gy is followed by chemotherapy(DDP,33mg/m2,ivgtt（intravenously guttae）,d1-3；VP-16,100mg/m2,ivgtt,d1-3；IFO,1.2g/m2,ivgtt,d1-3；DEX,40mg,ivgtt,d1-4；Mesna,0、4、8h after IFO,240mg/m2,iv,d1-3.Every 21 days for one cycle and three cycles are required ).Efficacy was evaluated every two cycles.
RADIATION	Radiotherapy	Suitable type intensity-modulated radiation therapy(IMRT)50Gy

Timeline

• Start date: 2011-01-01
• Primary completion: 2015-12-01
• Completion: 2019-05-01
• First posted: 2011-12-29
• Last updated: 2015-07-17

Locations

1 site across 1 country: China