Extranodal NK/T-cell Lymphoma, Nasal TypePhase 3NCT02631239
MESA Versus ESA in the Treatment of Early Stage NK/T-cell Lymphoma
A Phase 3 study testing Methotrexate, Etoposide and Dexamethasone in people with Extranodal NK/T-cell Lymphoma, Nasal Type, run by Ruijin Hospital at 1 site in China.
Trial summary
Extranodal natural killer (NK)/T-cell lymphoma (ENKTL), nasal type, is a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for 5%~10%. The frequency of ENKTL among NHL patients is significantly higher in Asia than in Western countries, with poor prognosis. Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Extranodal NK/T-cell Lymphoma, Nasal Type
- What is being tested?
- Methotrexate, Etoposide and Dexamethasone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2016to 17 Jul 2022
- Phase
- Phase 3
- 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 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pathological diagnosis of extranodal NK/T cell lymphoma, nasal type, previously untreated
- Age 14 ~ 70 years old
- ECOG(Eastern Cooperative Oncology Group）performance status 0~2
- Stage I to II
- Life expectancy>6 months
- Informed consented
Who cannot join
- Chemotherapy before
- Bone marrow transplantation before
- History of malignancy
- Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
- LVEF≤50%
- Other uncontrollable medical condition that may that may interfere the participation of the study
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- Lab at enrollment ALT or AST >3*ULN, AKP or bilirubin >2.5*ULN Creatinine>1.5*ULN
- Not able to comply to the protocol for mental or other unknown reasons
- Pregnant or lactation
- HIV infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of Etoposide, Dexamethasone, Peg-asparaginase or Plus Methotrexate With Sandwiched Radiotherapy in the Treatment of Stage I to II Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type
Extranodal natural killer (NK)/T-cell lymphoma (ENKTL), nasal type, is a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for 5%~10%. The frequency of ENKTL among NHL patients is significantly higher in Asia than in Western countries, with poor prognosis. Radiotherapy plus chemotherapy has improved the survival for these patients. But the optimal treatment schedule is controversial. The previous protocols usually contained high dose methotrexate, but the application of them is limited for the toxicity.
Read the detailed description
In mid-2016, we had the final evaluation of the phase 2 study of MESA with sandwiched radiotherapy in newly diagnosed early stage NKTCL (NCT02825147). We obtained the final overall response rate of MESA with sandwiched radiotherapy, while the 2-year progression free survival rate was not available at that timepoint. To make the study design of sample size more accurate, we changed the primary outcome endpoint from 2-year progression free survival rate to overall response rate. The change had been approved by the Ethics Committee in August 10, 2016. At that time, only fourteen patients were enrolled in NCT02631239.
- Being tested
- Methotrexate, Etoposide, Dexamethasone, Pegaspargase, Radiotherapy
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
1g/m2/d IV *1d
EtoposideDrug
200mg/d PO *3d
DexamethasoneDrug
40mg/d PO *3d
PegaspargaseDrug
2500IU/m2/d IM *1d
RadiotherapyRadiation
50-56Gy
| Study group | Role | What they receive |
|---|---|---|
| MESA | Active comparator | Methotrexate, etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy Receives: Drug: Methotrexate; Drug: Etoposide; Drug: Dexamethasone; Drug: Pegaspargase; Radiation: Radiotherapy |
| ESA | Experimental | Etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy Receives: Drug: Etoposide; Drug: Dexamethasone; Drug: Pegaspargase; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: 21 days after 4 cycles of chemotherapy
Secondary outcomes (3)
Overall survival
Measured: 2-year
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Measured: Day 1 of each course and then every 3 months for 2 years
Progression free survival
Measured: 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study start16 Mar 2016
- Primary completion5 Mar 2021
- Study completion17 Jul 2022 (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.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
- Investigators
- Weili Zhao, Prof, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631239
- Sponsor's protocol ID
- RJ-NK-2015
- Status last verified
- Aug 2021
- First submitted
- 28 Nov 2015
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Etoposide, Dexamethasone, Peg-asparaginase or Plus Methotrexate With Sandwiched Radiotherapy in the Treatment of Stage I to II Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type
- ClinicalTrials.gov ID
- NCT02631239
- Acronym / sponsor ID
- RJ-NK-2015
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 16 Mar 2016 (actual)
- Primary completion
- 5 Mar 2021 (actual)
- Study completion
- 17 Jul 2022 (estimated)
- First posted
- 16 Dec 2015 (estimated)
- 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.
Extranodal natural killer (NK)/T-cell lymphoma (ENKTL), nasal type, is a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for 5%~10%. The frequency of ENKTL among NHL patients is significantly higher in Asia than in Western countries, with poor prognosis. Radiotherapy plus chemotherapy has improved the survival for these patients. But the optimal treatment schedule is controversial. The previous protocols usually contained high dose methotrexate, but the application of them is limited for the toxicity.
Detailed description
In mid-2016, we had the final evaluation of the phase 2 study of MESA with sandwiched radiotherapy in newly diagnosed early stage NKTCL (NCT02825147). We obtained the final overall response rate of MESA with sandwiched radiotherapy, while the 2-year progression free survival rate was not available at that timepoint. To make the study design of sample size more accurate, we changed the primary outcome endpoint from 2-year progression free survival rate to overall response rate. The change had been approved by the Ethics Committee in August 10, 2016. At that time, only fourteen patients were enrolled in NCT02631239.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MESA | Active comparator | Drug: Methotrexate, Drug: Etoposide, Drug: Dexamethasone, Drug: Pegaspargase, Radiation: RadiotherapyMethotrexate, etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy |
| ESA | Experimental | Drug: Etoposide, Drug: Dexamethasone, Drug: Pegaspargase, Radiation: RadiotherapyEtoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Pathological diagnosis of extranodal NK/T cell lymphoma, nasal type, previously untreated
- Age 14 ~ 70 years old
- ECOG(Eastern Cooperative Oncology Group）performance status 0~2
- Stage I to II
- Life expectancy>6 months
Key exclusion criteria (10 listed)
- Chemotherapy before
- Bone marrow transplantation before
- History of malignancy
- Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
- LVEF≤50%
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 |
|---|---|---|
| Methotrexate1g/m2/d IV *1d | Drug | MESA |
| Etoposide200mg/d PO *3d | Drug | ESA, MESA |
| Dexamethasone40mg/d PO *3d | Drug | ESA, MESA |
| Pegaspargase2500IU/m2/d IM *1d | Drug | ESA, MESA |
| Radiotherapy50-56Gy | Radiation | ESA, MESA |
Primary outcome
Overall response rate
Time frame: 21 days after 4 cycles of chemotherapy
3 secondary outcomes
Overall survival
Time frame: 2-year
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: Day 1 of each course and then every 3 months for 2 years
Progression free survival
Time frame: 2-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
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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.
Weili Zhao, Prof principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methotrexate, Etoposide and Dexamethasone in people with Extranodal NK/T-cell Lymphoma, Nasal Type, run by Ruijin 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 10 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 25 Aug 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: 21 days after 4 cycles of chemotherapy). 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 25 Aug 2021.