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MESA Versus ESA in the Treatment of Early Stage NK/T-cell Lymphoma

Extranodal NK/T-cell Lymphoma, Nasal Type Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02631239
Study type Interventional
Source Ruijin Hospital
Contact
Status Active, not recruiting
Phase Phase 3
Start date March 16, 2016
Completion date July 17, 2022
View Details
See also
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Not yet recruiting NCT04676789 - Anti-PD-1 Antibody and Pegaspargase Combined With Radiotherapy in Early-Stage ENKTL Phase 2
Active, not recruiting NCT01991158 - GAD-M Regimen As First-Line Treatment in Untreated Extranodal NK/T Cell Lymphoma Phase 2
Active, not recruiting NCT03363555 - SHR-1210 in Patients With Relapsed or Refractory Extranodal NK/T Cell Lymphoma Phase 2
Recruiting NCT04405375 - GPED Regimen for Relapsed/Refractory or Advanced ENKTCL Phase 2
Recruiting NCT02742727 - CAR-pNK Cell Immunotherapy in CD7 Positive Leukemia and Lymphoma Phase 1/Phase 2
Recruiting NCT01667302 - Radiotherapy Followed by Adjuvant Chemotherapy in NK/T-cell Lymphoma Phase 2
Terminated NCT01667289 - Radiotherapy Alone Versus Concurrent Chemoradiation in Low Risk NK/T-cell Lymphoma Phase 2
Not yet recruiting NCT04338282 - Maintenance Therapy With Anti-PD-1 Antibody for Patients With NK/T-cell Lymphoma Phase 2
Active, not recruiting NCT04414163 - A Study of IMC-001 in Subjects With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type Phase 2
Recruiting NCT05978141 - A Registry for People With T-cell Lymphoma
Completed NCT02386813 - International Extranodal NK/T-cell Lymphoma Project N/A
Recruiting NCT01921790 - Avastin+ GemAOD As First-Line Treatment in NK/T Cell Lymphoma Phase 2
Completed NCT03493451 - Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms Phase 2