Back to resultsMESA Versus ESA in the Treatment of Early Stage NK/T-cell Lymphoma
Primary Purpose
Extranodal NK/T-cell Lymphoma, Nasal Type
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Methotrexate
Etoposide
Dexamethasone
Pegaspargase
Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Extranodal NK/T-cell Lymphoma, Nasal Type
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Ruijin Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
MESA
ESA
Arm Description
Methotrexate, etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy
Etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy
Outcomes
Primary Outcome Measures
Overall response rate
Secondary Outcome Measures
Overall survival
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Progression free survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02631239
Brief Title
MESA Versus ESA in the Treatment of Early Stage NK/T-cell Lymphoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 16, 2016 (Actual)
Primary Completion Date
March 5, 2021 (Actual)
Study Completion Date
July 17, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extranodal NK/T-cell Lymphoma, Nasal Type
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
256 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MESA
Arm Type
Active Comparator
Arm Description
Methotrexate, etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy
Arm Title
ESA
Arm Type
Experimental
Arm Description
Etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
1g/m2/d IV *1d
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
200mg/d PO *3d
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
40mg/d PO *3d
Intervention Type
Drug
Intervention Name(s)
Pegaspargase
Intervention Description
2500IU/m2/d IM *1d
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
50-56Gy
Primary Outcome Measure Information:
Title
Overall response rate
Time Frame
21 days after 4 cycles of chemotherapy
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
2-year
Title
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
Title
Progression free survival
Time Frame
2-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weili Zhao, Prof
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200021
Country
China
12. IPD Sharing Statement
Learn more about this trial
MESA Versus ESA in the Treatment of Early Stage NK/T-cell Lymphoma
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