An observational study in PTCL and Gemcitabine, sponsored by Shandong Provincial Hospital. Status unknown at 1 site in China. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-03-21.
Sponsored by Shandong Provincial Hospital · Observational
Peripheral T-cell Lymphoma (PTCL) is a heterogenic malignancy with poor outcome. There is no standardized treatment protocol for this kind of lymphoma. So, clinical trials are encouraged by National Comprehensive Cancer Network (NCCN) for those patients. Former studies confirmed that GDP (Gemcitabine, Dexamethasone, and Cis-platinum) is superior with CHOP (Cyclophosphamide, Adriamycin, Vincristine, and Prednisone). Combination with etoposide can improve the outcome of some patients with high risk factors. The aim of our study is to compare the response and survival rate of GDPE/CEOPE (gemcitabine, cis-platinum, etoposide, and dexamethasone/cyclophosphamide, vincristine, pharmorubicin, etoposide, and prednisone) with those of CEOPE regimen, looking forward to its superiority in efficacy and safety for the newly diagnosed adult patients with PTCL.
Peripheral T-cell Lymphoma (PTCL) is a heterogenic malignancy with poor outcome. Five-year PFS (progression-free survival) and OS (overall survival) for these patients received classic CHOP regimen is less than 30%. High-dose intensive chemotherapy doesn't demonstrate better response. At present, there is no standardized treatment protocol for this kind of lymphoma. So, clinical trials are encouraged by NCCN for those patients.
For the less efficacy of CHOP or CHOP-like regimen, multi-drug combination strategy has been the therapy tendency in PTCL. Zhang et al, reported that GDP compared with CHOP as the therapy strategy for PTCL-NOS (Not Otherwise Specified). The response rate was 78.57% in GDP group and 60.00% in CHOP group, respectively. DFS (disease-free survival) was 9.79 and 4.2 months in above two groups. They concluded that GDP is superior to CHOP. The main side-effect of two regimens is hematological toxicity. Combination with etoposide can improve the outcome of some patients with high risk factors. Furthermore, high-dose combined with ASCT (autologous stem cell transplantation) has been the first-line therapy for PTCL. Some refractory/relapsed patients with PTCL will benefit from allogeneic bone marrow transplantation. However, about 30% patients with PTCL have no chance to receive ASCT for multiple reasons. So, it is urgent to explore new combination-therapy regimen to improve the outcome for patients with PTCL.
The aim of our study is to compare the response and survival rate of GDPE/CEOPE (gemcitabine, cis-platinum, etoposide, and dexamethasone/cyclophosphamide, vincristine, pharmorubicin, etoposide, and prednisone) with those of CEOPE (/cyclophosphamide, vincristine, pharmorubicin, etoposide, and prednisone ) regimen, looking forward to its superiority in efficacy and safety for the newly diagnosed adult patients with PTCL.
Shandong Provincial Hospital is the lead sponsor of 61 studies on the registry; 23 are open to participants now.
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Newly Diagnosed Patients with Peripheral T-cell Lymphoma (PTCL)
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Exclusion Criteria:
patients with PTCL who receive GDPE/CEOPE as the first-line therapy strategy
patients with PTCL who receive CEOPE as the first-line therapy strategy
RR
Response Rate (including complete response \& partial response)
Time frame: 1 year
PFS
progression free survival
Time frame: 1 year
Plan to share: No
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Start is estimated for Apr 2019; primary completion for Mar 2020, 11 months later.
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This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Shandong Provincial Hospital