drugset / Trial / NCT03630731

Maintenance Treatment of Chidamide in Stage IV or Relapsed/Refractory Extranodal NK/T-cell Lymphoma

NCT03630731 ↗

Phase 2 Unknown 32 enrolled Chinese Academy of Medical Sciences
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Extranodal natural killer/T-cell lymphoma, nasal type (NKTCL) is a highly aggressive peripheral T-cell lymphoma (PTCL). Patients with newly diagnosed stage IV and relapsed/refractory have poor prognosis. 5-year progression-free survival was reported only 55%. Chidamide is a selective histone deacetylase inhibitor which was approved by FDA in treating relapsed or refractory PTCL. In phase I and II studies of chidamide, patients with relapsed or refractory NKTCL achieved a higher overall remission. Patients who obtained complete or partial remission had much favourable duration of remission. Thus, the invesgator design this study to evaluate the role of maintenance treatment of chidamide for induction chemotherapy-responded newly-diagnosed advanced and relapsed/refractory NKTCL patients.

Timeline

Start
2018-08
Primary completion
2020-03
Completion
2020-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Tucidinostat Small molecule 30 mg Oral