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

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ClinicalTrials.gov Identifier: NCT03884205
Recruitment Status : Unknown
Verified March 2019 by Wang Xin, Shandong Provincial Hospital.
Recruitment status was:  Recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Wang Xin, Shandong Provincial Hospital

Study Description
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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
PTCL Gemcitabine

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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: GDPE/CEOPE Compared With CEOPE as the First-line Therapy for Newly Diagnosed Patients With Peripheral T-Cell Lymphoma
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  1. RR [ Time Frame: 1 year ]
    Response Rate (including complete response & partial response)


Secondary Outcome Measures :
  1. PFS [ Time Frame: 1 year ]
    progression free survival


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Newly Diagnosed Patients with Peripheral T-cell Lymphoma (PTCL)
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884205


Contacts
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Contact: Yujie MS JIANG, Dr 8613370506886 ext 8613370506886 yujiejiang05@126.com
Contact: Xin Wang 8613370506886 ext 8613370506886 xinw007@126.com

Locations
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China, Shandong
Yujie MS JIANG Recruiting
Jinan, Shandong, China, 250014
Contact: Yujie M JIANG    8613370506886 ext 8613370506886    yujiejiang05@126.com   
Sponsors and Collaborators
Shandong Provincial Hospital
More Information
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Additional Information:

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Responsible Party: Wang Xin, Department Director, Shandong Provincial Hospital
ClinicalTrials.gov Identifier: NCT03884205    
Other Study ID Numbers: Gemcitabine-PTCL
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No