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

Nasal and Nasal-type NK/T-cell Lymphoma Clinical Trial

— CTTNKTL-I/II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01501136
• Other study ID #: hnslblzlzx2011
• Status: Recruiting
• Phase: Phase 4
• First received: November 25, 2011
• Last updated: July 15, 2015
• Start date: January 2011
• Est. completion date: May 2019

Study information

• Verified date: July 2015
• Source: Zhengzhou University
• Contact: Mingzhi Zhang, Pro,Dr
• Phone: 13838565629
• Email: mingzhi_zhang[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2019
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.
• 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.
• 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

Locations

Country	Name	City	State
China	Oncology Department of The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (10)

Lead Sponsor	Collaborator
Mingzhi Zhang	Cancer Hospital of Guizhou Province, Qingdao University, Second Hospital of Shanxi Medical University, Shanxi Province Cancer Hospital, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Wuhan TongJi Hospital, Wuhan Union Hospital, China, Wuhan University, Xinyang Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		up to end of follow-up-phase (approximately 24 months)	No
Secondary	Response rate	21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles.	every 6 weeks,up to completion of treatment(approximately 18 weeks )	No
Secondary	overall survival		up to the date of death (approximately 5 years)	No
Secondary	median survival time		5 years	No