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Treatment of Peripheral T-cell Lymphoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01664975
First Posted: August 14, 2012
Last Update Posted: October 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Zhengzhou University
Information provided by (Responsible Party):
Mingzhi Zhang, Zhengzhou University
  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
Intervention Model: Parallel Assignment
Masking: None (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 Mingzhi Zhang, Zhengzhou University:

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: up to end of follow-up-phase (approximately 24 months) ]

Secondary Outcome Measures:
  • 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

  • Overall Survival [ Time Frame: up to the date of death (approximately 5 years) ]
  • Median Survival Time [ Time Frame: 24 months ]

Enrollment: 100
Study Start Date: August 2011
Study Completion Date: April 2016
Primary Completion Date: April 2016 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01664975


Locations
China, Henan
Oncology Department of The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Sponsors and Collaborators
Mingzhi Zhang
Zhengzhou University
Investigators
Principal Investigator: Mingzhi Zhang, Pro,Dr The First Affiliated Hospital of Zhengzhou University
  More Information

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
First Submitted: August 10, 2012
First Posted: August 14, 2012
Results First Submitted: August 10, 2016
Results First Posted: October 5, 2016
Last Update Posted: October 5, 2016
Last Verified: August 2016

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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Gemcitabine
Cisplatin
Prednisone
Thalidomide
Cyclophosphamide
Doxorubicin
Prednisolone
Vincristine
Antineoplastic 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