Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 and up

Purinostat mesylate injections versus oral selinexor for relapsed or refractory diffuse large B‑cell lymphoma

Official title: A Randomized, Controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of the Purinostat Mesylate for Injection (PM) Compared to Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)

Run by Chengdu Zenitar Biomedical Technology Co., Ltd · NCT07011056 · Data updated 2026-11-12

This study tests whether purinostat mesylate injections work better than oral selinexor for adults with relapsed or refractory diffuse large B‑cell lymphoma.

More Diffuse Large B Cell Lymphoma trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment390 (estimated)
SponsorChengdu Zenitar Biomedical Technology Co., Ltd
Industry-sponsored
Locations1 site (Chengdu, Sichuan)
StatusRecruiting
StartedJuly 18, 2025
Main results expectedJune 30, 2029
Study endsJune 30, 2029
Registry record updatedSeptember 19, 2025
Trial IDNCT07011056 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18 or older with histologically confirmed relapsed or refractory DLBCL after at least two prior systemic therapies, measurable disease, ECOG performance status ≤2, and adequate organ function are appropriate candidates.

Probably not a fit

Patients with double/triple‑hit B‑cell lymphoma, prior transplantation, active or reactivated infections, pregnancy or breastfeeding, or other serious illnesses that make participation unsafe are unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with relapsed or refractory diffuse large B‑cell lymphoma who have received at least two prior systemic therapies are enrolled and assigned to receive one of two treatments. The experimental arm receives purinostat mesylate intravenously (11.2 mg/m2 on days 1, 4, 8 and 11 of a 21‑day cycle) for up to six cycles, while the control arm receives oral selinexor 60 mg twice weekly in 4‑week cycles. The main outcomes are objective response rate and overall survival as determined by a blinded independent central review (BICR). Safety and tolerability are monitored throughout treatment.

Why it matters

Potential benefit: If successful, this treatment could provide higher response rates and longer survival than current selinexor therapy for people with relapsed or refractory DLBCL.

How similar studies have gone: Selinexor has shown activity in relapsed/refractory DLBCL in prior studies, while purinostat mesylate has more limited early‑phase data and this Phase III comparison aims to clarify its benefit.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Age ≥ 18 years, no gender restrictions;
2. Histologically-confirmed DLBCL, Participants must have relapsed or failed to respond to at least two lines of prior systemic therapy (2-5 lines);
3. Participants must have measurable disease;
4. ECOG≤2;
5. Adequate organ function

Exclusion Criteria:

1. Pregnancy or breastfeeding;
2. Previous history of transplantation;
3. Double/Triple Hit B cell lymphoma;
4. Patient with known active infection, or reactivation of a latent infection;
5. Any serious diseases that investigator deems inappropriate to participate.

Where it's running

  • West China Hospital Sichuan University
    Chengdu, Sichuan, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.