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Treatment of Peripheral T-cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01664975
Recruitment Status : Completed
First Posted : August 14, 2012
Results First Posted : October 5, 2016
Last Update Posted : October 5, 2016
Zhengzhou University
Information provided by (Responsible Party):
Mingzhi Zhang, Zhengzhou University

Brief Summary:

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 )
Study Start Date : August 2011
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma Steroids

Arm Intervention/treatment
Experimental: GDPT regimen
GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) 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
CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) 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.

Primary Outcome Measures :
  1. Progression-free Survival [ Time Frame: up to end of follow-up-phase (approximately 24 months) ]

Secondary Outcome Measures :
  1. 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

  2. Overall Survival [ Time Frame: up to the date of death (approximately 5 years) ]
  3. Median Survival Time [ Time Frame: 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Age range 14-70 years old; ECOG performance status 0-2; Estimated survival time > 3 months Histological confirmed Peripheral 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 investigato

Information from the National Library of Medicine

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 identifier (NCT number): NCT01664975

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China, Henan
Oncology Department of The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Sponsors and Collaborators
Mingzhi Zhang
Zhengzhou University
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Principal Investigator: Mingzhi Zhang, Pro,Dr The First Affiliated Hospital of Zhengzhou University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mingzhi Zhang, the director of oncology department of the first affiliated hospital, Zhengzhou University Identifier: NCT01664975    
Other Study ID Numbers: hnslblzlzx2011-3
First Posted: August 14, 2012    Key Record Dates
Results First Posted: October 5, 2016
Last Update Posted: October 5, 2016
Last Verified: August 2016
Keywords provided by Mingzhi Zhang, Zhengzhou University:
Peripheral T-cell lymphoma;chemotherapy;
Additional relevant MeSH terms:
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Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin