A Phase III Clinical Study of Purinostat Mesylate for Injection in Patients With Diffuse Large B-cell Lymphoma
Recruiting
Phase 3
Interventional Study
Recurrent and Refractory Diffuse Large B-cell Lymphoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 390 (estimated)
- Sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd · Industry
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
The main objective of this study is to evaluate the differences in objective response rate and overall survival between the Purinostat mesylate for injection and selinexor, as assessed by blinded independent central review (BICR), in patients with relapsed or refractory diffuse large B-cell lymphoma.
.The participants in the experimental group will receive treatment with Purinostat mesylate for i…
Trial Locations
Loading…
Loading trial locations…
Eligibility 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
Ex…
Contacts