Trial intelligence / Profile preview

Genotype-guided Therapy in Newly Diagnosed Peripheral T-cell Lymphoma

NCT07706959Phase 2

Key facts

Status: Not yet recruiting
Start: Jul 2026
Primary completion: Jan 2028
Countries: 1
Sponsor: Ruijin Hospital

Drugs: azacitidineselinexordecitabinezeprumetostattucidinostat
Conditions: peripheral T-cell lymphoma (PTCL)

Overview

Phase 2, randomised, open-label trial of azacitidine, selinexor, decitabine, zeprumetostat, tucidinostat and 1 more in peripheral T-cell lymphoma (PTCL) (4 arms), sponsored by Ruijin Hospital. Primary endpoints: Recommended Phase 2 Dose and Complete Response Rate. Planned start Jul 2026; status: not yet recruiting.

Design

4 arms

Study design: RandomizedOpen-label

Subgroup 1 (TET2/RHOA)
Azacitidine + Selinexor + CHOP vs CHOP
Subgroup 2 (TP53)
Decitabine + Selinexor + CHOP vs CHOP
Subgroup 3 (Core epigenetic)
Zeprumetostat + chidamide + CHOP vs CHOP
Subgroup 4 (Other)
Azacitidine + Golidocitinib + CHOP vs CHOP

Who it enrols

Treatment-naive patients with histologically-confirmed Peripheral T-cell lymphoma, evaluable lesions, ECOG 0-2, adequate organ function, and available tumor tissue for NGS. Excludes patients with CNS lymphoma, active infections, HIV, or history of other malignancies.

Endpoints

Primary

Recommended Phase 2 Dose28 days from Cycle 2
Complete Response Rate6-8 weeks after last dose on Day 1 of Cycle 6

Secondary

Progression-Free Survivalup to approximately 2 years
Overall Survivalup to approximately 2 years
Overall Response Rate6-8 weeks after last dose on Day 1 of Cycle 6
Treatment-Related Adverse Eventsup to 4 years

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