Clinical Trial: Clinical Trial of Chidamide Combined With CHOP in Peripheral T-cell Lymphoma Patients
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: An Open-label, Multi-center, Phase Ib Clinical Trial of Chidamide Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphoma Patients
Brief 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 Summary: 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.
Sponsor: Chipscreen Biosciences, Ltd.
Current Primary Outcome: dose-limiting toxicity (DLT) [ Time Frame: Day 1 - 21 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Adverse events [ Time Frame: About 21 weeks ]
- complete response rate [ Time Frame: About 21 weeks ]
- Duration of response [ Time Frame: About 21 weeks ]
- Progression free survival [ Time Frame: About 21 weeks ]
- Objective response rate [ Time Frame: About 21 weeks ]
- Overall survival [ Time Frame: About 21 weeks ]
- Area under the concentration versus time curve (AUC) [ Time Frame: Day 1 of the lead-in period and Day 1 of the combination therapy ]
- Peak plasma concentration (Cmax) [ Time Frame: Day 1 of the lead-in period and Day 1 of the combination therapy ]
- Time of Cmax (Tmax) [ Time Frame: Day 1 of the lead-in period and Day 1 of the combination therapy ]
Original Secondary Outcome: Same as current
Information By: Chipscreen Biosciences, Ltd.
Dates:
Date Received: June 17, 2016
Date Started: July 2016
Date Completion: December 2019
Last Updated: June 20, 2016
Last Verified: June 2016
