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

NCT03630731 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-08-15

No results posted yet for this study

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.

Conditions

  • Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type

Interventions

DRUG

chidamide

For those who responded to induction chemotherapy, chidamide will be given OR orally 30mg biw for at least half a year

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Mei Dong · Cancer Hospital Chinese Academy of Medical Science

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-31
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03630731 on ClinicalTrials.gov