Treatment of Natural Killer/T Cell Lymphoma-I/II
CTTNKTL-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)
1 other identifier
interventional
200
1 country
1
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 Cell Lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2011
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 25, 2011
CompletedFirst Posted
Study publicly available on registry
December 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedJuly 17, 2015
July 1, 2015
4.9 years
November 25, 2011
July 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival
up to end of follow-up-phase (approximately 24 months)
Secondary Outcomes (3)
Response rate
every 6 weeks,up to completion of treatment(approximately 18 weeks )
overall survival
up to the date of death (approximately 5 years)
median survival time
5 years
Study Arms (5)
sequential trial,DDGP, radiotherapy
EXPERIMENTALsequential DDGP(gemcitabine,pegaspargase,cisplatin,dexamethasone) regiment followed by radiotherapy
sequential trial,VIPD, radiotherapy
EXPERIMENTALsequential VIPD（cisplatin，Etoposide,Ifosfamide,dexamethasone，Mesna） regiment followed by radiotherapy
sequential trial, radiotherapy,DDGP
EXPERIMENTALsequential radiotherapy followed by DDGP(gemcitabine,pegaspargase,cisplatin,dexamethasone) regiment
sequential trial,radiotherapy, VIPD
EXPERIMENTALsequential radiotherapy followed by VIPD（cisplatin,Etoposide,Ifosfamide,dexamethasone,Mesna）regiment chemotherapy
Radiotherapy
EXPERIMENTALSuitable type intensity-modulated radiation therapy (IMRT) 50GY
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mingzhi Zhanglead
- Second Hospital of Shanxi Medical Universitycollaborator
- Shanxi Province Cancer Hospitalcollaborator
- Wuhan Universitycollaborator
- Wuhan TongJi Hospitalcollaborator
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technologycollaborator
- Qingdao Universitycollaborator
- Cancer Hospital of Guizhou Provincecollaborator
- Xinyang Central Hospitalcollaborator
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicinecollaborator
Study Sites (1)
Oncology Department of The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Related Publications (1)
Zhang L, Wang Y, Li X, Li L, Wang X, Sun Z, Wu J, Fu X, Zhang X, Yu H, Wang G, Chang Y, Yan J, Zhou Z, Wu X, Nan F, Li W, Zhang M. Radiotherapy vs sequential pegaspargase, gemcitabine, cisplatin and dexamethasone and radiotherapy in newly diagnosed early natural killer/T-cell lymphoma: A randomized, controlled, open-label, multicenter study. Int J Cancer. 2021 Mar 15;148(6):1470-1477. doi: 10.1002/ijc.33329. Epub 2020 Oct 19.
PMID: 33034052DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mingzhi Zhang, Pro,Dr
The First Affiliated Hospital of Zhengzhou University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- the director of oncology department of the first affiliated hospital
Study Record Dates
First Submitted
November 25, 2011
First Posted
December 29, 2011
Study Start
January 1, 2011
Primary Completion
December 1, 2015
Study Completion
May 1, 2019
Last Updated
July 17, 2015
Record last verified: 2015-07