NCT02809573

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

An Open-label, Multi-center, Phase Ib Clinical Trial of Chidamide Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphoma Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Chipscreen Biosciences, Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this study is to assess the tolerability and safety include adverse events, vital signs, laboratory tests, etc., of a range of doses of chidamide combined with CHOP in peripheral T-cell lymphoma patients, and to determine the dose limit toxicity and the maximum tolerable dose.

Conditions

• Peripheral T-cell Lymphoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-08-11
• Primary completion: 2019-01-08
• Completion: 2019-01-08
• First posted: 2016-06-22
• Last updated: 2019-07-24

Locations

1 site across 1 country: China