PTCLNCT03884205
GDPE/CEOPE Compared With CEOPE for Newly Diagnosed Patients With PTCL
An observational study of PTCL and Gemcitabine, run by Shandong Provincial Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- PTCL, Gemcitabine
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 30 Sep 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- Child, Adult, Older adult
Study population: Newly Diagnosed Patients with Peripheral T-cell Lymphoma (PTCL)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yujie MS JIANG
Jinan, SD, 250014
Yujie M JIANG, 8613370506886 ext. 8613370506886, yujiejiang05@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- PTCL, Gemcitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
RR
Response Rate (including complete response \& partial response)
Measured: 1 year
Secondary outcomes (1)
PFS
progression free survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion31 Mar 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTCLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wang Xin, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884205
- Sponsor's protocol ID
- Gemcitabine-PTCL
- Status last verified
- Mar 2019
- First submitted
- 16 Mar 2019
- Last updated
- 21 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GDPE/CEOPE Compared With CEOPE as the First-line Therapy for Newly Diagnosed Patients With Peripheral T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03884205
- Acronym / sponsor ID
- Gemcitabine-PTCL
- Conditions
- PTCL, Gemcitabine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Newly Diagnosed Patients with Peripheral T-cell Lymphoma (PTCL)
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
RR
Time frame: 1 year
Response Rate (including complete response \& partial response)
1 secondary outcome
PFS
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTCL and Gemcitabine, run by Shandong Provincial Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yujie MS JIANG, Dr (8613370506886 ext. 8613370506886, yujiejiang05@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RR (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.