Treatment of Peripheral T-cell Lymphoma

• ClinicalTrials.gov Identifier: NCT01664975
• Recruitment Status: Completed
• First Posted: August 14, 2012
• Results First Posted: October 5, 2016
• Last Update Posted: October 5, 2016
• Sponsor: Mingzhi Zhang
• Collaborator: Zhengzhou University
• Information provided by (Responsible Party): Mingzhi Zhang, Zhengzhou University

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.

Condition or disease	Intervention/treatment	Phase
Peripheral T-cell Lymphoma	Drug: GDPT regimen; Drug: CHOP regimen	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• 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 )
• Study Start Date: August 2011
• Actual Primary Completion Date: April 2016
• Actual Study Completion Date: April 2016

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Progression-free Survival [ Time Frame: up to end of follow-up-phase (approximately 24 months) ]

Secondary Outcome Measures :

1. 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
2. Overall Survival [ Time Frame: up to the date of death (approximately 5 years) ]
3. Median Survival Time [ Time Frame: 24 months ]

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 70 Years (Child, Adult, Older Adult)
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Mingzhi Zhang, the director of oncology department of the first affiliated hospital, Zhengzhou University
• ClinicalTrials.gov Identifier: NCT01664975
• Other Study ID Numbers: hnslblzlzx2011-3
• First Posted: August 14, 2012
• 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