Tucidinostat in Combination With CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma With Follicul… (NCT06947967) | Clinical Trial Compass
RecruitingPhase 3
Tucidinostat in Combination With CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype
China224 participantsStarted 2025-08-12
Plain-language summary
A Randomised, Double-blind, Multicenter Phase Ⅲ Study to Evaluate the Efficacy and Safety of Tucidinostat versus Placebo in Combination with CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma with Follicular Helper of T Cell Phenotype
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provide written informed consent for the study.
. Male or female, age ≥ 18 years and ≤80 years.
. ECOG PS 0,1 or 2.
. Participants with histologically proven peripheral T-cell lymphoma with T-follicular helper phenotype (PTCL-TFH), including: a. angioimmunoblastic T-cell lymphoma, b. follicular helper T-cell lymphoma, follicular type, c. follicular helper T-cell lymphoma, NOS.
. At least one measurable disease according to the Lugano 2014 Classification.
. Laboratory criteria are as follows except that caused by lymphoma assessed by the investigator (without receiving any supportive treatment for the following parameters within 2 weeks from the last dose prior to study entry):
.Expected survival≥6 months.
Exclusion criteria
. Presence of CNS involvement.
. Received prior therapies targeting lymphoma.
. Participants planned for autologous or allogeneic transplant as consolidation after CR.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Participants with any other malignancy in past 5 years, except for local tumors that have been cured.
. Prior treatment with cytotoxic drugs for another condition (e.g., rheumatoid arthritis).
. Any investigational therapy within 3 months.
. Contraindication to any of the individual components of CHOP.
. Corticosteroid use \> 30 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control, and the following conditions for inclusion must be met, a. participants receiving corticosteroid treatment with ≤ 30 mg/day of prednisone or equivalent must be documented to be on a stable dose of at least 4 weeks' duration prior to randomization, b. If glucocorticoid treatment is urgently required for lymphoma symptom control prior to the start of study treatment, prednisone 100 mg or equivalent could be given for a maximum of 7 days, but all tumor assessments must be completed prior to start of glucocorticoid treatment.