Treatment of Peripheral T-cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT01664975|
Recruitment Status : Completed
First Posted : August 14, 2012
Results First Posted : October 5, 2016
Last Update Posted : October 5, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Peripheral T-cell Lymphoma||Drug: GDPT regimen Drug: CHOP regimen||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Multi-center Clinical Trial on Treatment of Peripheral T-cell Lymphoma With DGPT Regiment (Gemcitabine,Cisplatin,Prednisone ,Thalidomide )|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|