Extranodal NK/T-cell Lymphoma, Nasal Type
Conditions
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.
Interventions
DRUGMethotrexate
1g/m2/d IV \*1d
DRUGEtoposide
200mg/d PO \*3d
DRUGDexamethasone
40mg/d PO \*3d
DRUGPegaspargase
2500IU/m2/d IM \*1d
RADIATIONRadiotherapy
50-56Gy
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | 21 days after 4 cycles of chemotherapy |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Outcome results
None listed