NCT01664975

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 10, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
6 months until next milestone

Results Posted

Study results publicly available

October 5, 2016

Completed
Last Updated

October 5, 2016

Status Verified

August 1, 2016

Enrollment Period

4.7 years

First QC Date

August 10, 2012

Results QC Date

August 10, 2016

Last Update Submit

August 10, 2016

Conditions

Peripheral T-cell Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Progression-free Survival

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

Secondary Outcomes (3)

  • Response Rate

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

  • Overall Survival

    up to the date of death (approximately 5 years)

  • Median Survival Time

    24 months

Study Arms (2)

GDPT regimen

EXPERIMENTAL

GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) regimen

Drug: GDPT regimen

CHOP regimen

EXPERIMENTAL

CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen

Drug: CHOP regimen

Interventions

GDPT regimenDRUG

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.

GDPT regimen
CHOP regimenDRUG

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.

CHOP regimen

Eligibility Criteria

Age14 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • volunteers who signed informed consent.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncology Department of The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Related Publications (2)

  • 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.

    PMID: 32550864DERIVED

  • 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.

    PMID: 28597542DERIVED

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

VAP-cyclo protocol

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Results Point of Contact

Title
Mingzhi Zhang
Organization
Zhengzhou University
mingzhi_zhang@126.com
0371-66295564

Study Officials

  • Mingzhi Zhang, Pro,Dr

    The First Affiliated Hospital of Zhengzhou University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
the director of oncology department of the first affiliated hospital

Study Record Dates

First Submitted

August 10, 2012

First Posted

August 14, 2012

Study Start

August 1, 2011

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

October 5, 2016

Results First Posted

October 5, 2016

Record last verified: 2016-08

Locations

CN(1)