GDPE/CEOPE Compared With CEOPE for Newly Diagnosed Patients With PTCL
1 other identifier
observational
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2019
CompletedFirst Posted
Study publicly available on registry
March 21, 2019
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedMarch 21, 2019
March 1, 2019
1 year
March 16, 2019
March 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
RR
Response Rate (including complete response \& partial response)
1 year
Secondary Outcomes (1)
PFS
1 year
Study Arms (2)
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
Eligibility Criteria
Newly Diagnosed Patients with Peripheral T-cell Lymphoma (PTCL)
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yujie MS JIANG
Jinan, SD, 250014, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department Director
Study Record Dates
First Submitted
March 16, 2019
First Posted
March 21, 2019
Study Start
April 1, 2019
Primary Completion
March 31, 2020
Study Completion
September 30, 2020
Last Updated
March 21, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share