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TR115 VS Investigator's Choice in Relapsed/Refractory Peripheral T/NK Cell Lymphoma

ConditionsPTCLNK T-Cell Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTarapeutics Science Inc.

About this trial

This is a randomized, open-label, multicenter Phase III study evaluating the efficacy and safety of TR115, an EZH2 inhibitor, versus investigator's choice (chidamide, golidocitinib, mitoxantrone liposome, or gemcitabine) in patients with relapsed and/or refractory peripheral T/NK-cell lymphoma. Approximately 180 patients will be randomized in a 1:1 ratio. The primary endpoint is progression-free survival (PFS) assessed by an Independent Review Committee (IRC). The key secondary endpoint is overall survival (OS). The study is being conducted at approximately 40 to 60 centers across China.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed peripheral T-cell lymphoma (PTCL), including PTCL-NOS, AITL, ALCL, or NKTCL

Received at least one prior systemic therapy and prior exposure to at least one novel agent (e.g., chidamide, pralatrexate, brentuximab vedotin, etc.) or refractory/intolerant to such therapies

Age ≥18 years

ECOG performance status 0-1

Disqualifiers

Prior treatment with EZH2 or EZH1/2 inhibitors resulting in disease progression (intolerance permitted)

Known central nervous system involvement of lymphoma

Active uncontrolled infection requiring systemic therapy

Significant or uncontrolled cardiovascular disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • TR115

    Drug

    TR115 will be administered orally twice daily until documented disease progression, unacceptable toxicity, withdrawal of consent, death, or study discontinuation.

  • Investigator's Choice

    Drug

    Investigator's choice treatment with chidamide, golidocitinib, mitoxantrone hydrochloride liposome, or gemcitabine hydrochloride administered according to the respective approved prescribing information.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: TR115 tabletExperimental treatment 1 intervention
Group B: Investigator's ChoiceActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

Assessed by Independent Review Committee (IRC) per Lugano 2014 criteria

Time frame
From randomization to disease progression or death from any cause, whichever occurs first, assessed up to 36 months.

Secondary outcomes

1

Overall Survival (OS)

Time from randomization to death from any cause.

Time frame
From randomization to death from any cause, assessed up to 36 months.
2

Objective Response Rate (ORR)

Proportion of participants achieving complete response (CR) or partial response (PR) as assessed by Independent Review Committee (IRC) and investigator according to Lugano 2014 criteria.

Time frame
Up to 36 months
3

Disease Control Rate (DCR)

Proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) as assessed by IRC and investigator according to Lugano 2014 criteria.

Time frame
Up to 36 months
4

Duration of Response (DOR)

Time from first documented response (CR or PR) to disease progression or death from any cause, whichever occurs first, as assessed by IRC and investigator according to Lugano 2014 criteria.

Time frame
From first documented response to disease progression or death, assessed up to 36 months.

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Peking University Cancer Hospital Status unavailable 100142, Beijin, Beijing MunicipalityChinaChina

Sponsors and contacts

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

Tarapeutics Science Inc.

Lead sponsor

Source ClinicalTrials.gov

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