Chidamide Plus CHOEP Combined With Upfront ASCT in Untreated Peripheral T-cell Lymphoma

Summary

The purpose of this study is to determine determine the maximum tolerated dose (MTD) and safety of the combination of Chidamide combined with CHOEP(cyclophosphamide， epirubicin,vindesine, etoposide and prednisone) regimen as first line treatment in newly-diagnosed T-NHL.

Conditions

• T Cell Non-Hodgkin's Lymphoma

Interventions

DRUG

Chidamide

Six cycles of therapy will be administered,and each cycle of treatment is 28 days. Phase I: Patients were treated at the following dose levels: 15, 20, and 25 mg twice per week to determine the MDT Phase II: If MTD was not reached at 25mg dose level of Chidamide. The followed study will use 20mg twice per week as experimental dose.

DRUG

Cyclophosphamide

Cyclophosphamide(750mg/m2) was administered intravenously on d1

DRUG

Epirubicin

epirubicin (70mg/m2)was administered intravenously on d1;

DRUG

Vindesine

vindesine (4mg)was administered intravenously on d1;

DRUG

Etoposide

etoposide (100mg) was administered intravenously on d1,2,3.

DRUG

Prednisone

prednisone (60mg/m2)was administered intravenously by oral d1-5.

Sponsors & Collaborators

• Chinese PLA General Hospital

  collaborator OTHER

• Peking University First Hospital

  collaborator OTHER

• Peking University Third Hospital

  collaborator OTHER

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Tianjin Medical University Cancer Institute and Hospital

  collaborator OTHER

• Peking Union Medical College Hospital

  lead OTHER

Principal Investigators

• Daobin Zhou, M.D · Peking Union Medical College Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-03-31

Primary Completion

2020-03-31

Completion

2023-03-31

Countries

• China

Study Locations