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

Sponsor
Shandong Provincial Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03884205
Collaborator
(none)
120
Enrollment
1
Location
18
Anticipated Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    GDPE/CEOPE Compared With CEOPE as the First-line Therapy for Newly Diagnosed Patients With Peripheral T-Cell Lymphoma
    Anticipated Study Start Date :
    Apr 1, 2019
    Anticipated Primary Completion Date :
    Mar 31, 2020
    Anticipated Study Completion Date :
    Sep 30, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    test group

    patients with PTCL who receive GDPE/CEOPE as the first-line therapy strategy
    control group

    patients with PTCL who receive CEOPE as the first-line therapy strategy

    Outcome Measures

    Primary Outcome Measures

    1. RR [1 year]

      Response Rate (including complete response & partial response)

    Secondary Outcome Measures

    1. PFS [1 year]

      progression free survival

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 75 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yujie MS JIANG Jinan Shandong China 250014

    Sponsors and Collaborators

    • Shandong Provincial Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wang Xin, Department Director, Shandong Provincial Hospital
    ClinicalTrials.gov Identifier:
    NCT03884205
    Other Study ID Numbers:
    • Gemcitabine-PTCL
    First Posted:
    Mar 21, 2019
    Last Update Posted:
    Mar 21, 2019
    Last Verified:
    Mar 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 21, 2019