Lymphoma, Extranodal NK-T-CellPhase 2MTNNCT01933282
MESA Treatment for NK/T Cell Lymphoma
A Phase 2 study testing MESA chemotherapy and MESA in people with Lymphoma, Extranodal NK-T-Cell, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
Study on the efficacy and safety of MESA chemotherapy for treating NK/T cell lymphoma Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Lymphoma, Extranodal NK-T-Cell
- What is being tested?
- MESA chemotherapy and MESA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Jan 2015
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pathological diagnosis is NK/T cell lymphoma；
- At least one objective evaluation ( measurable ) lesions
- Age 15 ~ 60 years old, men and women are not limited
- ECOG(Eastern Cooperative Oncology Group）performance status 0~3，Expected to survive more than 3 months;
- Heart, kidney function in the normal range
- Liver function: transminase< 2 times the normal value
- pregnancy tests of women childbearing age must be negative; Men and women agree to use effective contraception during the treatment and the following year
- Before the test sign the written informed consent
Who cannot join
- The early use of methotrexate or/and L-asparaginase;
- Pregnant or nursing, psychiatric patients complicated with malignant tumor
- At the same time the application of other trial drug, drug contraindications exist in research;
- Serious infection or metabolic diseases
- Liver dysfunction, serum direct bilirubin, indirect bilirubin, transaminase 2 times higher than normal; serum total protein or albumin below normal;
- Renal insufficiency, creatinine clearance rate was 2 times higher than normal, especially the creatinine clearance rate is less than 30ml/min;
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- Before entering the group, blood: White blood cell< 3×10E9/L; absolute neutrophil count<1.5×10E9/L; platelet<100×10E9/L ( bone marrow is not violated ); platelet count <75×10E9/L ( bone marrow invasion ); hemoglobin<100g/L.
- In the 6 months before entering the group, patients with uncontrolled or serious cardiovascular diseases, including myocardial infarction, III-IV class heart failure, uncontrolled angina or clinically significant pericardial disease, and diabetes and phlebitis;
- HIV antibody positive, HBsAg positive after antiviral HBV(hepatitis B virus) DNA titer in 104copies/ml the following groups. HIV antibody positive, HBsAg+ and DNA titer in 104copies/ml after antiviral HBV therapy
- Coagulation abnormalities.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Hemaology, Xi jing Hospital,The Fourth Military Medical University
Xi'an, Shaanxi, 710032
rong liang, associate professor, 86 13384933870, rongliang1017@gmail.com
Li Zhu, nurse, 86 29 775202, xueyeke@fmmu.edu.cn
About this study
Official title: Phase II Study of MESA Chemotherapy in Patients With Natural Killer/T Cell Lymphoma
Study on the efficacy and safety of MESA chemotherapy for treating NK/T cell lymphoma
Read the detailed description
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. Despite radiotherapy and chemotherapy, the prognosis for ENKTL patients is poor, with 5-year median survival time for primary nasal site was 5 years, for non-nasal extranodal sites 6 months. ENKTL is so aggressive and has high mortality rate and till now there is no standard therapy. In recent years SMILE chemotherapy has clinical efficacy and is one of first line therapy for ENKTL. However it is apparent that this regimen is extremely toxic with grade 4 neutropenia especially for Asian patients. On these grounds, new therapy MESA is used for Asian patients with ENKTL in order to achieve good efficacy and safety.
- Conditions
- Lymphoma, Extranodal NK-T-Cell
- Being tested
- MESA chemotherapy, MESA
- Keywords
- MESA, chemotherapy,NK/T cell lymphoma
- 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.
MESA chemotherapyDrug
Methotrexate 2g/ m2，IV d1 etoposide 100mg/ m2，VD d2，d3，d4， dexamethasone 20mg/ m2，VD d2，d3，d4, d5 Polyehylene glycol-asparaginase muscular injection 2500IU/ m2, d5
MESADrug
Methotrexate etoposide dexamethasone Polyehylene glycol-asparaginase
| Study group | Role | What they receive |
|---|---|---|
| MESA chemotherapy | Experimental | Methotrexate etoposide dexamethasone Polyehylene glycol-asparaginase Methotrexate 2g/ m2，IV d1 etoposide 100mg/ m2，VD d2，d3，d4 dexamethasone 20mg/ m2，VD d2，d3，d4，d5 Polyehylene glycol-asparaginase muscular injection 2500IU/ m2, d5 Receives: Drug: MESA chemotherapy; Drug: MESA |
What is being measured
The primary outcome is the main question the study is designed to answer.
response criteria for CR(complete remission)by physical examination,lymph nodes masses and bone marrow test.
After 6 cycle of MESA treatment,response assessments for CR,PR(partial remission) and NR(no remission) should include appropriate imaging studies(CT,MRI and PET-CT) based on the type of study performed at initial workup, endoscopy with visual inspection, repeat biopsies and measurement of EBV DNA
Measured: 24 week
Secondary outcomes (1)
rate of survival
prognosis assessment by rates of survival including PFS(Progression-Free-Survival) and OS(Overall survival)at 1 year,2 years,3 years after induction therapies and follow up therapies.
Measured: 1 year, 2 years, 3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Extranodal NK-T-CellStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xie-qun Chen, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933282
- Sponsor's protocol ID
- MESA-NKT2013
- Acronym
- MTN
- Status last verified
- Dec 2013
- First submitted
- 16 Aug 2013
- Last updated
- 24 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of MESA Chemotherapy in Patients With Natural Killer/T Cell Lymphoma
- ClinicalTrials.gov ID
- NCT01933282
- Acronym / sponsor ID
- MTN / MESA-NKT2013
- Conditions
- Lymphoma, Extranodal NK-T-Cell
- Keywords
- MESA, chemotherapy,NK/T cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 2 Sep 2013 (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.
Study on the efficacy and safety of MESA chemotherapy for treating NK/T cell lymphoma
Detailed description
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. Despite radiotherapy and chemotherapy, the prognosis for ENKTL patients is poor, with 5-year median survival time for primary nasal site was 5 years, for non-nasal extranodal sites 6 months. ENKTL is so aggressive and has high mortality rate and till now there is no standard therapy. In recent years SMILE chemotherapy has clinical efficacy and is one of first line therapy for ENKTL. However it is apparent that this regimen is extremely toxic with grade 4 neutropenia especially for Asian patients. On these grounds, new therapy MESA is used for Asian patients with ENKTL in order to achieve good efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MESA chemotherapy | Experimental | Drug: MESA chemotherapy, Drug: MESAMethotrexate etoposide dexamethasone Polyehylene glycol-asparaginase Methotrexate 2g/ m2，IV d1 etoposide 100mg/ m2，VD d2，d3，d4 dexamethasone 20mg/ m2，VD d2，d3，d4，d5 Polyehylene glycol-asparaginase muscular injection 2500IU/ m2, d5 |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Pathological diagnosis is NK/T cell lymphoma；
- At least one objective evaluation ( measurable ) lesions
- Age 15 ~ 60 years old, men and women are not limited
- ECOG(Eastern Cooperative Oncology Group）performance status 0~3，Expected to survive more than 3 months;
- Heart, kidney function in the normal range
Key exclusion criteria (10 listed)
- The early use of methotrexate or/and L-asparaginase;
- Pregnant or nursing, psychiatric patients complicated with malignant tumor
- At the same time the application of other trial drug, drug contraindications exist in research;
- Serious infection or metabolic diseases
- Liver dysfunction, serum direct bilirubin, indirect bilirubin, transaminase 2 times higher than normal; serum total protein or albumin below normal;
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 |
|---|---|---|
| MESA chemotherapyMethotrexate 2g/ m2，IV d1 etoposide 100mg/ m2，VD d2，d3，d4， dexamethasone 20mg/ m2，VD d2，d3，d4, d5 Polyehylene glycol-asparaginase muscular injection 2500IU/ m2, d5 | Drug | MESA chemotherapy |
| MESAMethotrexate etoposide dexamethasone Polyehylene glycol-asparaginase | Drug | MESA chemotherapy |
Primary outcome
response criteria for CR(complete remission)by physical examination,lymph nodes masses and bone marrow test.
Time frame: 24 week
After 6 cycle of MESA treatment,response assessments for CR,PR(partial remission) and NR(no remission) should include appropriate imaging studies(CT,MRI and PET-CT) based on the type of study performed at initial workup, endoscopy with visual inspection, repeat biopsies and measurement of EBV DNA
1 secondary outcome
rate of survival
Time frame: 1 year, 2 years, 3years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
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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 MESA chemotherapy and MESA in people with Lymphoma, Extranodal NK-T-Cell, run by Air Force Military Medical University, China 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 8 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 24 Dec 2013. 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?
Contact RONG LIANG, professor (86 13384933870, rongliang1017@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response criteria for CR(complete remission)by physical examination,lymph nodes masses and bone marrow test. (time frame: 24 week). 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 24 Dec 2013.