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 â…¢ 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 range18 Years – 80 Years
SexALL
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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.
✕. 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).
✕. 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.