Treatment of Peripheral T-cell Lymphoma

Phase 4

Completed

• Conditions: Peripheral T-cell Lymphoma
• Interventions: Drug: GDPT regimen; Drug: CHOP regimen

• Registration Number: NCT01664975
• Lead Sponsor: Mingzhi Zhang

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.

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-08-10
• Study First Submitted QC: 2012-08-10
• Study First Posted: 2012-08-14
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-08
• Results First Submitted: 2016-08-10
• Results First Submitted QC: 2016-08-10
• Last Update Submitted: 2016-08-10
• Results First Posted: 2016-10-05
• Last Update Posted: 2016-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GDPT regimen	GDPT regimen	GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) regimen
CHOP regimen	CHOP regimen	CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen

Primary Outcome Measures

Name	Time	Method
Progression-free Survival	up to end of follow-up-phase (approximately 24 months)

Secondary Outcome Measures

Name	Time	Method
Response Rate	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	up to the date of death (approximately 5 years)
Median Survival Time	24 months

Trial Locations

Locations (1)

Oncology Department of The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China