Treatment of Peripheral T-cell Lymphoma
The purpose of this study is to evaluate the efficacy and safety of GDPT regiment (gemcitabine，cisplatin,Prednisone ,Thalidomide
) for patients with Peripheral T-cell lymphoma.
|Peripheral T-cell Lymphoma||Drug: GDPT regimen Drug: CHOP regimen||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Multi-center Clinical Trial on Treatment of Peripheral T-cell Lymphoma With DGPT Regiment (Gemcitabine,Cisplatin,Prednisone ,Thalidomide )|
- Progression-free Survival [ Time Frame: up to end of follow-up-phase (approximately 24 months) ]
- Response Rate [ Time Frame: 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 [ Time Frame: up to the date of death (approximately 5 years) ]
- Median Survival Time [ Time Frame: 24 months ]
|Study Start Date:||August 2011|
|Study Completion Date:||April 2016|
|Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Experimental: GDPT regimen
Drug: GDPT regimen
GDPT regimen(Gemcitabine,Cisplatin,Prednisone ,Thalidomide) Cisplatin(DDP) 25 mg/m2,ivgtt（intravenously guttae）,d1-3;Prednisone 60mg/m2,p.o,d1-5;Gemcitabine(GEM) 800mg/m2,ivgtt,30min,d1,8;Thalidomide,p.o,200mg/d,Continued use to the end of chemotherapy .Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles.
Experimental: CHOP regimen
Drug: CHOP regimen
CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5.
Patients with Peripheral 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 GDPT regiment (gemcitabine，cisplatin,Prednisone ,Thalidomide
) in the patients with Peripheral T-cell lymphoma.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664975
|Oncology Department of The First Affiliated Hospital of Zhengzhou University|
|Zhengzhou, Henan, China, 450052|
|Principal Investigator:||Mingzhi Zhang, Pro,Dr||The First Affiliated Hospital of Zhengzhou University|