NCT06492629

Toripalimab Combined With Chidamide for the Treatment of Relapsed/Refractory Peripheral T-Cell Lymphoma

Phase II Clinical Study of Toripalimab Combined With Chidamide for the Treatment of Relapsed/Refractory Peripheral T-Cell Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of Toripalimab combined with Chidamide in the treatment of relapsed/refractory peripheral T-cell lymphoma.

Detailed description

The study is an open-label, single-arm, single-center, Phase II clinical trial. The trial design adopts the Simon optimal two-stage design. The number of effective cases in the first stage is 15; if fewer than 5 effective cases are observed, the trial will be terminated, otherwise, the trial will continue. The total sample size for the trial is at least 43 cases. All subjects receive treatment with the Toripalimab and Chidamide regimen until the subject has been treated for 2 years, disease progression occurs, intolerable toxic reactions occur, or treatment is terminated for other reasons, whichever comes first. After the end of treatment, subjects are required to complete the end-of-treatment visit within 7 days. Safety follow-up after the last dose is required at 30 days (±7 days) and 90 days (±7 days) after the last dose, with adverse event (AE) collection up to 90 days after the last dose. After the end of dosing, subjects enter the follow-up period with a telephone follow-up every 12 weeks (±7 days) to collect survival information and subsequent anti-tumor treatments until death or loss to follow-up. If a subject discontinues treatment for reasons other than PD (progressive disease), efficacy evaluation should continue at the same frequency as during the dosing period until the subject experiences PD, starts a new anti-tumor treatment, dies, or is lost to follow-up. Treatment should be continued as long as clinical benefit is observed, until the patient is no longer tolerating it, for a maximum of 2 years of treatment. Atypical responses may be observed (for example, a temporary increase in tumor size or the appearance of new small lesions within the first few months, followed by a reduction in tumor size). If the patient's clinical symptoms are stable or continue to improve, even with preliminary evidence of disease progression, based on the overall judgment of clinical benefit, it may be considered to continue treatment with this regimen until disease progression is confirmed.

Conditions

• PTCL

Interventions

Type	Name	Description
DRUG	Toripalimab	Intravenous infusion, 240mg, administered once every 3 weeks, until the subject has been treated for 2 years, disease progression occurs, intolerable toxic reactions are experienced, or treatment is discontinued for other reasons.
DRUG	chidamide	Take 30 mg (6 tablets) each time, and take the medication twice a week, with at least 3 days between doses (such as on Monday and Thursday, Tuesday and Friday, Wednesday and Saturday, etc.), to be taken 30 minutes after meals.

Timeline

• Start date: 2024-04-03
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-07-09
• Last updated: 2024-07-09

Locations

1 site across 1 country: China