Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07372352

Zeprumetostat, Azacitidine Combined With Lipo-MIT in R/R PTCL

Led by The First Affiliated Hospital of Soochow University · Updated on 2026-01-28

26

Participants Needed

1

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This clinical trial is a Phase II study investigating the effectiveness and safety of a three-drug combination-Zeprumetostat, Azacitidine, and Mitoxantrone Hydrochloride Liposome-in adults with relapsed or refractory peripheral T-cell lymphoma (PTCL). PTCL is an aggressive type of non-Hodgkin lymphoma that has limited treatment options after the first line of therapy. The study aims to enroll approximately 26 patients at a single center in China. Eligible participants will receive up to 6 cycles of induction therapy with all three drugs, followed by up to 2 years of maintenance therapy with Zeprumetostat alone if they respond to treatment. The main goal is to evaluate the overall response rate (how many patients experience tumor shrinkage). Secondary goals include assessing how long patients live without their disease getting worse, how long they survive overall, and the safety profile of this treatment combination. The study will also explore whether specific genetic markers or viral infections are linked to how well patients respond. This study is important because it tests a novel, potentially less toxic, and more effective combination for a patient population with high unmet medical need. All participants will be closely monitored for treatment response and side effects throughout the trial.

CONDITIONS

Official Title

Zeprumetostat, Azacitidine Combined With Lipo-MIT in R/R PTCL

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Relapsed or refractory peripheral T-cell lymphoma after first-line or higher treatment.
  • Age 18 years or older.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
  • Presence of measurable target lesions (lesions with longest diameter > 1.5 cm and longest perpendicular diameter  1.0 cm, up to six lesions).
  • Adequate major organ function including:
    • Hemoglobin  70 g/L, platelet count  50 x 10^9/L, neutrophil count  1.0 x 10^9/L (without recent transfusions or growth factors within 1 week before screening).
    • Echocardiographic left ventricular ejection fraction  50%.
    • Creatinine  132 umol/L or creatinine clearance  60 ml/min.
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)  3 times the upper limit of normal.
  • Negative pregnancy test for women of childbearing potential.
  • Agreement by both male and female patients to use effective contraception during treatment and for 1 year after.
  • Life expectancy greater than 3 months.
  • Voluntary signed informed consent form.
Not Eligible

You will not qualify if you...

  • Major surgery or severe trauma within 2 weeks before enrollment, or ongoing significant adverse effects.
  • Other malignancies within 3 years before enrollment, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostatic intraepithelial neoplasia, or cervical carcinoma in situ.
  • History of stroke or intracranial hemorrhage within the past 3 months.
  • Severe cardiovascular diseases (e.g., NYHA class III/IV heart disease, recent myocardial infarction, unstable arrhythmias or angina).
  • Severe pulmonary diseases such as severe obstructive pulmonary disease or symptomatic bronchospasm.
  • HIV infection or uncontrolled active hepatitis B or C virus infection.
  • Uncontrolled active infection.
  • Pregnant or breastfeeding women.
  • Life-threatening diseases or organ dysfunction posing safety risks as judged by the investigator.
  • Conditions interfering with absorption or metabolism of study drugs or risking study results.
  • Lymphoma involving the central nervous system.
  • Conditions interfering with full study participation or interpretation of data as judged by the investigator.

AI-Screening

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215000

Actively Recruiting

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Research Team

T

Ting Xu, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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