MESA Versus ESA in the Treatment of Early Stage NK/T-cell Lymphoma
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
1 other identifier
interventional
256
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2016
Longer than P75 for phase_3
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
November 28, 2015
CompletedFirst Posted
Study publicly available on registry
December 16, 2015
CompletedStudy Start
First participant enrolled
March 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 17, 2022
CompletedAugust 25, 2021
August 1, 2021
5 years
November 28, 2015
August 19, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Overall response rate
21 days after 4 cycles of chemotherapy
Secondary Outcomes (3)
Overall survival
2-year
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Day 1 of each course and then every 3 months for 2 years
Progression free survival
2-year
Study Arms (2)
MESA
ACTIVE COMPARATORMethotrexate, etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy
ESA
EXPERIMENTALEtoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
Study Sites (1)
Ruijin Hospital
Shanghai, Shanghai Municipality, 200021, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Weili Zhao, Prof
Ruijin Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 28, 2015
First Posted
December 16, 2015
Study Start
March 16, 2016
Primary Completion
March 5, 2021
Study Completion
July 17, 2022
Last Updated
August 25, 2021
Record last verified: 2021-08