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Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of High dose of Methotrexate combined with gemcitabine, pegaspargase and dexamethasone (GAD-M regimen) as first-line treatment in patients with de novo extranodal NK/T cell lymphoma.


Clinical Trial Description

Studies have shown that effects of P glycoprotein mediated chemotherapy resistance reduce the therapeutic efficacy of anthracycline-based chemotherapy of NK/T cell lymphoma, and agents like pegaspargase and large doses of Methotrexate is not affected by the P glycoprotein. A number of reports suggest that gemcitabine combined with other chemotherapy drugs has good application prospect in the treatment of lymphomas. Dexamethasone is used in combination with other agents for the treatment of lymphomas which may be implicated in the development or growth of some cancers. So we explored to evaluate the efficacy and safety of High dose of methotrexate combined with gemcitabine, pegaspargase and dexamethasone (GAD-M regimen) as first-line treatment in patients with untreated extranodal NK/T cell lymphoma. ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01991158
Study type Interventional
Source Sun Yat-sen University
Contact
Status Active, not recruiting
Phase Phase 2
Start date November 2013
Completion date November 2020

See also
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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
Active, not recruiting NCT02631239 - MESA Versus ESA in the Treatment of Early Stage NK/T-cell Lymphoma Phase 3
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
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Completed NCT03493451 - Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms Phase 2