Treatment of Peripheral T-cell Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Zhengzhou University
Sponsor:
Collaborator:
Zhengzhou University
Information provided by (Responsible Party):
Mingzhi Zhang, Zhengzhou University
ClinicalTrials.gov Identifier:
NCT01664975
First received: August 10, 2012
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Peripheral T-cell Lymphoma
Drug: GDPT regimen
Drug: CHOP regimen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 )

Resource links provided by NLM:


Further study details as provided by Zhengzhou University:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: up to end of follow-up-phase (approximately 24 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • response rate [ Time Frame: every 6 weeks,up to completion of treatment(approximately 18 weeks ) ] [ Designated as safety issue: No ]
    21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles

  • overall survival [ Time Frame: up to the date of death (approximately 5 years) ] [ Designated as safety issue: No ]
  • median survival time [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   14 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01664975

Contacts
Contact: Mingzhi zhang, Pro,Dr 13838565629 Mingzhi_zhang@126.com

Locations
China, Henan
Oncology Department of The First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450052
Contact: Mingzhi Zhang, Pro,Dr    13838565629    mingzhi_zhang@126.com   
Sponsors and Collaborators
Mingzhi Zhang
Zhengzhou University
Investigators
Principal Investigator: Mingzhi Zhang, Pro,Dr The First Affiliated Hospital of Zhengzhou University
  More Information

No publications provided

Responsible Party: Mingzhi Zhang, the director of oncology department of the first affiliated hospital, Zhengzhou University
ClinicalTrials.gov Identifier: NCT01664975     History of Changes
Other Study ID Numbers: hnslblzlzx2011-3
Study First Received: August 10, 2012
Last Updated: September 19, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Zhengzhou University:
Peripheral T-cell lymphoma;chemotherapy;
RR;PFS;OS

Additional relevant MeSH terms:
Lymphoma, T-Cell
Lymphoma
Lymphoma, T-Cell, Peripheral
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Cisplatin
Prednisone
Thalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on October 01, 2014