RecruitingPhase 3NCT05075460

Tucidinostat, Azacitidine Combined With CHOP Versus CHOP in Patients With Untreated Peripheral T-cell Lymphoma

A Prospective, Multicenter, Phase III, Non-randomized Study of Tucidinostat, Azacitidine Combined With CHOP Versus CHOP in Patients With Untreated Peripheral T-cell Lymphoma


Sponsor

Peking Union Medical College Hospital

Enrollment

107 participants

Start Date

Oct 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, multicenter, phase III study of Tucidinostat, Azacitidine combined with CHOP versus CHOP in patients with untreated peripheral T-cell lymphoma


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing a standard chemotherapy combination (CHOP) for T-cell lymphoma against the same treatment plus two additional drugs — tucidinostat (an epigenetic drug) and azacitidine — to see if the added drugs improve outcomes. **You may be eligible if...** - You are 18–70 years old - You have newly diagnosed peripheral T-cell lymphoma confirmed by pathology - Your general health is adequate (ECOG 0–2) - Your blood counts and organ function (heart, lungs, liver, kidneys) are within acceptable limits **You may NOT be eligible if...** - You have ALK-positive T-cell lymphoma or NK/T-cell nasal-type lymphoma - You have an uncontrolled active infection - You had a heart attack or unstable chest pain in the last 6 months - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTucidinostat, Azacitidine combined with CHOP

Azacitidine: 200 mg D1200 mg D2100 mg D3 subcutaneous injection Tucidinostat: 20mg / time, D1, 4, 8, 11; Take medicine with 200ml warm boiled water 30 minutes after breakfast. CHOP chemotherapy: * Cyclophosphamide (CTX) 750mg / m2 intravenous infusion, day 1; * Epirubicin (EPI) 70mg / m2 intravenous infusion, day 1; * Vinoresin (VDS) 4mg intravenous infusion, day 1; * Prednisone 100mg orally, day 1-5. Every 21 days is a course of treatment


Locations(1)

Peking Union Medical College Hospital

Beijing, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05075460


Related Trials