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GDPE/CEOPE Compared With CEOPE for Newly Diagnosed Patients With PTCL

GDPE/CEOPE Compared With CEOPE as the First-line Therapy for Newly Diagnosed Patients With Peripheral T-Cell Lymphoma

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03884205
Enrollment
120
Registered
2019-03-21
Start date
2019-04-01
Completion date
2020-09-30
Last updated
2019-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gemcitabine, PTCL

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Shandong Provincial Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 75 Years

Inclusion criteria

* Peripheral T Cell Lymphoma, Not Otherwise Specified * Angioimmunoblastic T Cell Lymphoma * ALK-negative Anaplastic Large Cell Lymphoma * Enteropathy Associated T Cell Lymphoma * Subcutaneous Panniculitis Like T Cell Lymphoma * Acute T-cell Leukemia/Lymphoma

Exclusion criteria

* woman in pregnancy or lactation * allergic to any intervention drug * unsuitable to the study due to severe complication * enrolled to other study during the past 6 months * NK/T lymphoma ALK-positive Anaplastic Large Cell Lymphoma

Design outcomes

Primary

MeasureTime frameDescription
RR1 yearResponse Rate (including complete response & partial response)

Secondary

MeasureTime frameDescription
PFS1 yearprogression free survival

Countries

China

Contacts

Primary ContactYujie MS JIANG, Dr
yujiejiang05@126.com8613370506886
Backup ContactXin Wang
xinw007@126.com8613370506886

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026