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

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.

Study Overview

• Status: Unknown
• Conditions: Gemcitabine; 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.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Yujie MS JIANG, Dr; Phone Number: 8613370506886 8613370506886; Email: yujiejiang05@126.com
• Study Contact Backup: Name: Xin Wang; Phone Number: 8613370506886 8613370506886; Email: xinw007@126.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • Recruiting
      • Yujie MS JIANG
      • Contact: Yujie M JIANG; Phone Number: 8613370506886 8613370506886; Email: yujiejiang05@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Newly Diagnosed Patients with Peripheral T-cell Lymphoma (PTCL)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RR	Response Rate (including complete response & partial response)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	progression free survival	1 year

Collaborators and Investigators

• Sponsor: Shandong Provincial Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): March 31, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: March 16, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): March 21, 2019
• Last Update Submitted That Met QC Criteria: March 19, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Gemcitabine-PTCL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No