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Clinical Trial of Chidamide Combined With CHOP in Peripheral T-cell Lymphoma Patients

NCT02809573 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-07-24

No results posted yet for this study

Summary

The purpose of this dose-escalation study is to assess the safety and tolerability of treatment with Chidamide in a range of doses combined with CHOP in fixed dose in patients with newly diagnosed peripheral T-cell lymphoma.

Conditions

  • Peripheral T-cell Lymphoma

Interventions

DRUG

Chidamide

In the lead-in period, patients take a single dose of Chidamide tablet on the first day and then off for 3 days before the first cycle begins. In the subsequent treatment cycles, Chidamide tablets are given orally on Day 1,4,8 and 11 of each cycle.

DRUG

cyclophosphamide

On Day 1, cyclophosphamide is given in a 20-minute intravenous (IV) infusion at 750 mg/m\^2 in 5 minutes after chidamide administration

DRUG

adriacin

On Day 1, Adriacin is given in a 20-minute IV infusion at 50 mg/m\^2 soon after cyclophosphamide administration.

DRUG

vincristine

On Day 1, vincristine is given in IV infusion at 1.4 mg/m\^2 after adriacin administration.

DRUG

prednisone

On Day 1 to 5, prednisone is given orally at 100 mg once a day

Sponsors & Collaborators

  • Chipscreen Biosciences, Ltd.

    lead INDUSTRY

Principal Investigators

  • Yuankai Shi, MD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-11
Primary Completion
2019-01-08
Completion
2019-01-08

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT02809573 on ClinicalTrials.gov