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Not yet recruiting NCT07724782

Multi-Cohort Study of Zeprumetostat Combinations for Relapsed/Refractory PTCL

Phase I / Phase II Interventional PTCL-NOS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Zeprumetostat( an EZH2 inhibitor) + X.
Who it may be relevant to
Registry conditions: PTCL-NOS. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Multi Cohort Exploratory Clinical Study of the EZH2 Inhibitor Zeprumetostat Combination Regimen in Relapsed/Refractory Peripheral T Cell Lymphoma

Overview

This is a single-arm, multi-cohort, multicenter, phase Ib/IIa clinical study designed to evaluate the safety and efficacy of Zeprumetostat (an EZH2 inhibitor) in combination with different therapeutic agents/regimens - specifically, the JAK1 inhibitor golidocitinib and the GemOx chemotherapy regimen (gemcitabine plus oxaliplatin) - in patients with relapsed or refractory peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS) and T-follicular helper cell lymphoma (TFHL). The trial comprises a phase Ib dose-escalation phase and a phase IIa dose-expansion phase. Two combination cohorts are established: Cohort A (zemitostatin + golidocitinib) and Cohort B (zemitostatin + GemOx). Subjects will be randomly assigned to either Cohort A or Cohort B.

Interventions

  • Drug Zeprumetostat( an EZH2 inhibitor) + X
    Zeprumetostat( an EZH2 inhibitor) + JAK1 inhibitor or GemOx

Primary outcome measures

  • Summary of DLT events (Phase Ib) [Time frame: At the end of Cycle 1 (each cycle is 21 days)]
  • Overall response rate (Phase Ⅱ) [Time frame: Through study completion, an average of 2 years after EZH2+JAK1/GemOx (Day 1)]
Secondary outcome measures (5)
  • Complete response rate [Time frame: Through study completion, an average of 2 years after EZH2+JAK1/GemOx (Day 1)]
  • Duration of response [Time frame: Through study completion, an average of 2 years after EZH2+JAK1/GemOx (Day 1)]
  • Progression free survival [Time frame: Through study completion, an average of 2 years after EZH2+JAK1/GemOx (Day 1)]
  • Overall survival [Time frame: Through study completion, an average of 3 years after EZH2+JAK1/GemOx (Day 1)]
  • Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE [Time frame: Through study completion, an average of 2 years after EZH2+JAK1/GemOx (Day 1)]

Eligibility criteria

Inclusion criteria

  • Age 18 years or older, both males and females are eligible;
  • Histologically confirmed peripheral T-cell lymphoma (PTCL) including PTCL-NOS and TFHL that has relapsed or is refractory after at least one line of systemic therapy. The definitions are as follows:

Relapse: Patients who achieved a Complete Response (CR) in previous treatments and have new lesions at the original site or elsewhere; Refractory: Patients who did not achieve CR after adequate treatment. For nasal-type NK/T-cell lymphoma, previous treatments must have included a chemotherapy regimen containing asparaginase;

  • Patients who have undergone prior hematopoietic stem cell transplantation are allowed;
  • ECOG PS 0-2
  • Life expectancy greater than 3 months.
  • Adequate organ function
  • Contraception during study
  • Informed consented

Exclusion criteria

  • Prior treatment with EZH2 inhibitors or EZH1/2 inhibitors before enrollment;
  • Peripheral T-cell lymphoma of subtypes other than PTCL-NOS and TFHL;
  • History of other primary invasive malignancies that have not been in remission or have been in remission for no more than 3 years;
  • Central nervous system involvement (meningeal or parenchymal);
  • Known hypersensitivity to any study drugs;
  • Participation in another clinical trial of an investigational drug within 4 weeks prior to the start of the study.
  • Pregnant or lactation
  • Active infection.
  • Diseases and medical history:
  • Requires continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers
  • Has multiple factors affecting oral medication administration (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
  • Has a history of psychoactive substance abuse that cannot be discontinued
  • Has any severe and/or uncontrolled disease.
  • Uncontrollable autoimmune disease,
  • Not able to comply to the protocol for mental or other unknown reasons
  • Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tianjin Cancer Hospital — Tianjin

Identifiers

NCT: NCT07724782 · MA-PTCL-II-003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗