NCT02631239

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 256 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 14 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Extranodal NK/T-cell Lymphoma, Nasal Type

Interventions

Type	Name	Description
DRUG	Methotrexate	1g/m2/d IV \*1d
DRUG	Etoposide	200mg/d PO \*3d
DRUG	Dexamethasone	40mg/d PO \*3d
DRUG	Pegaspargase	2500IU/m2/d IM \*1d
RADIATION	Radiotherapy	50-56Gy

Timeline

• Start date: 2016-03-16
• Primary completion: 2021-03-05
• Completion: 2022-07-17
• First posted: 2015-12-16
• Last updated: 2021-08-25

Locations

1 site across 1 country: China