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Treatment of Peripheral T-cell Lymphoma

Primary Purpose

Peripheral T-cell Lymphoma

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

GDPT regimen

CHOP regimen

About this trial

This is an interventional treatment trial for Peripheral T-cell Lymphoma focused on measuring Peripheral T-cell lymphoma;chemotherapy;, RR;PFS;OS

Eligibility Criteria

14 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Oncology Department of The First Affiliated Hospital of Zhengzhou University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

GDPT regimen

CHOP regimen

Arm Description

GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) regimen

CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen

Outcomes

Primary Outcome Measures

Progression-free Survival

Secondary Outcome Measures

Response Rate

21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles

Overall Survival

Median Survival Time

Full Information

NCT ID

NCT01664975

First Posted

August 10, 2012

Last Updated

August 10, 2016

Sponsor

Mingzhi Zhang

Collaborators

Zhengzhou University

1. Study Identification

Unique Protocol Identification Number

NCT01664975

Brief Title

Treatment of Peripheral T-cell Lymphoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mingzhi Zhang

Collaborators

Zhengzhou University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral T-cell Lymphoma

Keywords

Peripheral T-cell lymphoma;chemotherapy;, RR;PFS;OS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GDPT regimen

Arm Type

Experimental

Arm Description

GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) regimen

Arm Title

CHOP regimen

Arm Type

Experimental

Arm Description

CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen

Intervention Type

Drug

Intervention Name(s)

GDPT regimen

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

CHOP regimen

Intervention Description

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 Measure Information:

Title

Progression-free Survival

Time Frame

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

Secondary Outcome Measure Information:

Title

Response Rate

Description

21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles

Time Frame

every 6 weeks,up to completion of treatment(approximately 18 weeks )

Title

Overall Survival

Time Frame

up to the date of death (approximately 5 years)

Title

Median Survival Time

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mingzhi Zhang, Pro,Dr

Organizational Affiliation

The First Affiliated Hospital of Zhengzhou University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oncology Department of The First Affiliated Hospital of Zhengzhou University

City

Zhengzhou

State/Province

Henan

ZIP/Postal Code

450052

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

32550864

Citation

Sun Y, Li L, Li X, Zhang L, Wang X, Fu X, Sun Z, Zhang X, Li Z, Wu J, Yu H, Chang Y, Yan J, Wu X, Zhou Z, Nan F, Tian L, Zhang M. Outcomes of GDPT (gemcitabine, cisplatin, prednisone, thalidomide) versus CHOP in newly diagnosed peripheral T-cell lymphoma patients. Ther Adv Med Oncol. 2020 May 27;12:1758835920923829. doi: 10.1177/1758835920923829. eCollection 2020.

Results Reference

derived

PubMed Identifier

28597542

Citation

Li L, Duan W, Zhang L, Li X, Fu X, Wang X, Wu J, Sun Z, Zhang X, Chang Y, Nan F, Yan J, Li Z, Young KH, Zhang M. The efficacy and safety of gemcitabine, cisplatin, prednisone, thalidomide versus CHOP in patients with newly diagnosed peripheral T-cell lymphoma with analysis of biomarkers. Br J Haematol. 2017 Sep;178(5):772-780. doi: 10.1111/bjh.14763. Epub 2017 Jun 9.

Results Reference

derived

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Treatment of Peripheral T-cell Lymphoma

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