Tucidinostat in Combination With CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChipscreen Biosciences, Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone)
  • Tucidinostat
  • Placebo

Treatment groups

224 Participants
are divided into 2 treatment groups

Sponsors and collaborators