NCT02856997

Chidamide With ICE Regimen for Relapsed/Refractory Peripheral T Cell Lymphoma

Chidamide With ICE Regimen for Relapsed/Refractory Peripheral T Cell Lymphoma: A Phase II Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Yuankai Shi · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Chidamide with ICE regimen in patients with relapsed/refractory Peripheral T Cell lymphoma.

Detailed description

Efficacy of the combined regimen is evaluated primarily by objective remission rate, including complete remission, unverified complete remission and partial remission, also by duration of remission, progression free survival, and overall survival. Safety is accessed by: 1. The type, incidence, severity of incidents related to the use of the regimen. 2. Laboratory abnormalities, including the type, incidence, severity, relationship with the use of the regimen. 3. Incidence of level 3-4 incidents and laboratory abnormalities.

Conditions

• Peripheral T Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Chidamide with ICE regimen	Chidamide and ICE regimen, dosage described in arm description

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-03-01
• First posted: 2016-08-05
• Last updated: 2016-08-05