Hepatosplenic T-cell Lymphoma Clinical Trial
Official title:
CEOP/IVE/GDP Compared With CEOP as the First-line Therapy for Newly Diagnosed Adult Patients With Peripheral T-cell Lymphoma (PTCL)
Peripheral T-cell Lymphoma (PTCL) is a heterogenic malignancy with poor outcome. Five-year PFS and OS for these patients received classic CHOP regimen (cyclophosphamide, vincristin, doxorubicin and prednisone) 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. The novel regimen IVE/MTX (ifosfamide,
etoposideļ¼epirubucin/methotrexate)-ASCT(autologous stem-cell transplantation ) was piloted
for patients eligible for intensive treatment, followed by auto-stem cell transplantation.
Five-years PFS (progression-free survival) and OS (overall survival) were 52% and 60%
respectively, significantly improved compared with the historical group treated with
anthracycline-based chemotherapy. The encouraged results were extended to the peripheral T
cell lymphoma-non specified (PTCL-NOS). Former studies reported that GDP (gemcitabine,
cis-platinum, and dexamethasone) 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 with CHOP. The main side-effect of two regimens is
hematological toxicity. Furthermore, high-dose combined with ASCT has been the first-line
therapy for PTCL. However, only about 30% patients with PTCL have 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 CEOP/IVE/GDP
(cyclophosphamide, vincristin, epirubucin and prednisone/ ifosfamide, epirubucin, and
etoposide/ gemcitabine, cis-platinum, and dexamethasone) with those of CEOP regimen, looking
forward to its superiority in efficacy and safety for the newly diagnosed adult patients with
PTCL.
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