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

ConditionLymphoma, T-Cell, Peripheral
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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

    Drug

    Cyclophosphamide 750 mg/m2 , intravenous infusion on day 1 of each 21-day cycle. Doxorubicin 70mg/m2 , intravenous infusion on day 1 of each 21-day cycle, total 6 cycles. Vincristine 1.4mg/m2(Max dose 2mg), intravenous injection on day 1 of each 21-day cycle , total 6 cycles. Prednisone 100 mg, oral, day 1-5 of each 21-day cycle,total 6 cycles.

  • Tucidinostat

    Drug

    oral, taking as prescribed by the protocol

  • Placebo

    Drug

    oral, taking as prescribed by the protocol

Treatment groups

224 Participants
are divided into 2 treatment groups
Group A: C-CHOPExperimental treatment 2 interventions
Group B: CHOPPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

Defined as the duration from the date of randomization to the date of progression, relapse from CR, or death, whichever occurred first.

Time frame
Up to approximately 60 month

Secondary outcomes

1

Complete Response Rate(CRR)

Time frame
Up to approximately 36 months
2

Overall response rate (ORR)

Defined as the proportion of subjects with measurable disease who achieve CR or partial response (PR)

Time frame
Up to approximately 36months
3

Event Free Survival (EFS)

Defined as the duration from the date of randomization to the date of disease progression, initiation of subsequent systemic antilymphoma therapy for residual disease, or death, whichever occurs first.

Time frame
Up to approximately 60 month
4

Disease-Free Survival (DFS)

Defined for participants achieving CR as the period from the date of the initial CR until the date of relapse or death from any cause.

Time frame
Up to approximately 60 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chipscreen Biosciences, Ltd.

Lead sponsor

Source ClinicalTrials.gov
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