Extranodal NK/T-cell Lymphoma, Nasal TypePhase 2NCT04405375
GPED Regimen for Relapsed/Refractory or Advanced ENKTCL
A Phase 2 study testing gemcitabin, Pegaspargase and Etoposide in people with Extranodal NK/T-cell Lymphoma, Nasal Type, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of gemcitabine, pegaspargase, etoposide, and dexamethasone (GPED) in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients (ENKTCL). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Extranodal NK/T-cell Lymphoma, Nasal Type
- What is being tested?
- gemcitabin, Pegaspargase and Etoposide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2020to 30 Apr 2023
- Phase
- Phase 2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathology and immunohistochemistry confirmed diagnosis of NK/Tcell lymphoma according to WHO 2016 criteria.
- refractory or relapsed after initial remission, or stage III-IV de novo patients
- PET/CT or CT/MRI with at least one objectively evaluable lesion.
- General status ECOG score 0-3 points.
- The laboratory test within 1 week before enrollment meets the following conditions:
- Blood routine: Hb>80g/L, PLT>50×10e9/L.
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- Liver function: ALT, AST, TBIL ≤2 times the upper limit of normal.
- Renal function: Cr is normal.
- Cardiac function: LVEF≥50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking.
- Sign the informed consent form
Who cannot join
- Active infection requires ICU treatment. Concomitant HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time are notexcluded.
- Significant organ dysfunction Pregnant and lactating women.
- Those who were known to be allergic to drugs in the study regimen.
- Patients with other tumors who require surgery or chemotherapy within 6 months.
- Other experimental drugs are being used.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tongren Hospital
Beijing, 100730
Liang Wang, MD, +8615001108693, wangliangtrhos@126.com
About this study
Official title: Gemcitabine, Pegaspargase, Etoposide, and Dexamethasone (GPED) for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma : a Single Arm,Open-lable,Phase II Study
The purpose of this study is to evaluate the efficacy and safety of gemcitabine, pegaspargase, etoposide, and dexamethasone (GPED) in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients (ENKTCL).
Read the detailed description
Pegaspargase is the cornor stone for the treatment of ENKTCL, and gemcitabine has been shown to be active in ENKTCL. For several patients with relapsed/refractory or advance ENKTCL, hemophagocytic sysdrome (HPS) occurs, and the prognosis is very poor. Studies have found that etoposide and dexamethasone may be effective in controlling HPS. Thus, this study aims to evaluate the role of gemcitabine, pegaspargase, etoposide, and dexamethasone (GPED) in the treatment of relapsed/refractory or advance ENKTCL, wishing to improve the prognosis for these patients.
- Being tested
- gemcitabin, Pegaspargase, Etoposide, Dexamethasone
- Keywords
- extranodal NK/T-cell lymphoma, gemcitabine, etoposide, dexamethasone, pegaspargase, hemophagocytic syndrome
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell, Lymphohistiocytosis, Hemophagocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabinDrug
1.25g/㎡ d1, repeated every 21 days
PegaspargaseDrug
2500IU/㎡ d1, total dose=<3750IU, repeated every 21 days
EtoposideDrug
75mg/㎡ d1-3, repeated every 21 days
DexamethasoneDrug
20mg d1-4
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | gemcitabine 1.25g/㎡ d1, pegaspargase 2500IU/㎡ d1 (max dose =<3750IU) etoposide 75mg/㎡ d1-3 dexamethasone 20mg d1-4 repeated every 21 days, up to 6 cycles. Receives: Drug: gemcitabin; Drug: Pegaspargase; Drug: Etoposide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year progression free survival (PFS) rate
PFS is defined as date of enrollment to date of disease progression, relapse, death of any reason, or last follow-up, whichever comes first.
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcomes (3)
Overall response rate (ORR)
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
Measured: evaluated every 2 cycles of treamtent, up to one month after the end of treatment
Complete response rate (CRR)
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
Measured: evaluated every 2 cycles of treamtent, up to one month after the end of treatment
2-year overall survial (OS) rate
OS is defined as date of enrollment to date of death of any reason, or last follow-up, whichever comes first.
Measured: From date of enrollment until the date of death from any cause or last follow-up, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start21 Mar 2020
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extranodal NK/T-cell Lymphoma, Nasal TypeStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JING-WEN WANG, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405375
- Sponsor's protocol ID
- TRhos-ENKTCL-6
- Status last verified
- May 2020
- First submitted
- 24 May 2020
- Last updated
- 28 May 2020
- 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 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gemcitabine, Pegaspargase, Etoposide, and Dexamethasone (GPED) for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma : a Single Arm,Open-lable,Phase II Study
- ClinicalTrials.gov ID
- NCT04405375
- Acronym / sponsor ID
- TRhos-ENKTCL-6
- Keywords
- extranodal NK/T-cell lymphoma, gemcitabine, etoposide, dexamethasone, pegaspargase, hemophagocytic syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 21 Mar 2020 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 28 May 2020 (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.
The purpose of this study is to evaluate the efficacy and safety of gemcitabine, pegaspargase, etoposide, and dexamethasone (GPED) in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients (ENKTCL).
Detailed description
Pegaspargase is the cornor stone for the treatment of ENKTCL, and gemcitabine has been shown to be active in ENKTCL. For several patients with relapsed/refractory or advance ENKTCL, hemophagocytic sysdrome (HPS) occurs, and the prognosis is very poor. Studies have found that etoposide and dexamethasone may be effective in controlling HPS. Thus, this study aims to evaluate the role of gemcitabine, pegaspargase, etoposide, and dexamethasone (GPED) in the treatment of relapsed/refractory or advance ENKTCL, wishing to improve the prognosis for these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Drug: gemcitabin, Drug: Pegaspargase, Drug: Etoposide, Drug: Dexamethasonegemcitabine 1.25g/㎡ d1, pegaspargase 2500IU/㎡ d1 (max dose =<3750IU) etoposide 75mg/㎡ d1-3 dexamethasone 20mg d1-4 repeated every 21 days, up to 6 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histopathology and immunohistochemistry confirmed diagnosis of NK/Tcell lymphoma according to WHO 2016 criteria.
- refractory or relapsed after initial remission, or stage III-IV de novo patients
- PET/CT or CT/MRI with at least one objectively evaluable lesion.
- General status ECOG score 0-3 points.
- The laboratory test within 1 week before enrollment meets the following conditions:
Key exclusion criteria (5 listed)
- Active infection requires ICU treatment. Concomitant HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time are notexcluded.
- Significant organ dysfunction Pregnant and lactating women.
- Those who were known to be allergic to drugs in the study regimen.
- Patients with other tumors who require surgery or chemotherapy within 6 months.
- Other experimental drugs are being used.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gemcitabin1.25g/㎡ d1, repeated every 21 days | Drug | treatment arm |
| Pegaspargase2500IU/㎡ d1, total dose=<3750IU, repeated every 21 days | Drug | treatment arm |
| Etoposide75mg/㎡ d1-3, repeated every 21 days | Drug | treatment arm |
| Dexamethasone20mg d1-4 | Drug | treatment arm |
Primary outcome
2-year progression free survival (PFS) rate
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
PFS is defined as date of enrollment to date of disease progression, relapse, death of any reason, or last follow-up, whichever comes first.
3 secondary outcomes
Overall response rate (ORR)
Time frame: evaluated every 2 cycles of treamtent, up to one month after the end of treatment
Complete response rate (CRR)
Time frame: evaluated every 2 cycles of treamtent, up to one month after the end of treatment
2-year overall survial (OS) rate
Time frame: From date of enrollment until the date of death from any cause or last follow-up, assessed up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- 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?
A Phase 2 study testing gemcitabin, Pegaspargase and Etoposide in people with Extranodal NK/T-cell Lymphoma, Nasal Type, run by Beijing Tongren 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 10 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 28 May 2020. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year progression free survival (PFS) rate (time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months). 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 28 May 2020.