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Completed

NCT Number: NCT01664975

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.

Completed

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Key information

Age range

14 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oncology Department of The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GDPT regimen

Drug

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.

CHOP regimen

Drug

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 outcomes

  1. Progression-free Survival

    Time frame: up to end of follow-up-phase (approximately 24 months)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mingzhi Zhang

Other

Collaborators

  • Zhengzhou University

Registry information

Official study title

A Randomized Controlled Multi-center Clinical Trial on Treatment of Peripheral T-cell Lymphoma With DGPT Regiment (Gemcitabine,Cisplatin,Prednisone ,Thalidomide )

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Aug 14, 2012
Registry last updated
Oct 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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