Treatment of Peripheral T-cell Lymphoma
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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 ) |
- Progression-free survival [ Time Frame: up to end of follow-up-phase (approximately 24 months) ] [ Designated as safety issue: No ]
- 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 |
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| Contact: Mingzhi zhang, Pro，Dr | 13838565629 | Mingzhi_zhang@126.com |
| 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 | |
| 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: | August 18, 2012 |
| 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 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 Cyclophosphamide Prednisone Thalidomide |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Myeloablative Agonists Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on June 18, 2013