Purinostat mesylate injections versus oral selinexor for relapsed or refractory diffuse large B‑cell lymphoma
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)
PHASE3 · Chengdu Zenitar Biomedical Technology Co., Ltd · NCT07011056
This study tests whether purinostat mesylate injections work better than oral selinexor for adults with relapsed or refractory diffuse large B‑cell lymphoma.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 390 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chengdu Zenitar Biomedical Technology Co., Ltd (industry) |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT07011056 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Chengdu, Sichuan
- West China Hospital Sichuan University — Chengdu, Sichuan, China (RECRUITING)
Study contacts
- Study coordinator: Liangkun Sun
- Email: liangkunsun@zenitar.cn
- Phone: 86+15885742617
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Recurrent and Refractory Diffuse Large B-cell Lymphoma