Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02226965 | PNT2258 for Treatment of Patients With r/r DLBCL (Wolverine) | PHASE2 | COMPLETED | 45 | — | — | Dec 1, 2014 | Aug 22, 2018 | Jun 29, 2023 | 27 | United States, Puerto Rico |
The proportion of patients with complete response (CR/complete metabolic response \[CMR\]) or partial response (PR/partial metabolic response \[PMR\]) according to the revised 2014 International Working Group (IWG) criteria for lymphoma (Cheson 2014)
| Arm | Type | Description |
|---|---|---|
| PNT2258 | EXPERIMENTAL | PNT2258 will be administered at 120 mg/m2 on days 1-5 of a 21-day cycle. Treatment may continue unless there is disease progression or the occurrence of unacceptable toxicity for a total of 8 "induction" cycles of therapy. Subjects with CR/CMR, PR/PMR or SD/NMR at the end-of-cycle 8 scan then receive ongoing PNT2258 therapy at a dose of 100 mg/m2 on days 1-4 of a 28 day cycle until progressive disease, the occurrence of unacceptable toxicity, non-compliance, voluntary withdrawal or if in the opinion of the investigator the subject is no longer benefiting from exposure to PNT2258. |
| Name | Type | Description |
|---|---|---|
| PNT2258 | DRUG | - |
Inclusion Criteria: Histologically confirmed diffuse large B-cell lymphoma that is refractory to prior therapy or relapsed after prior therapy. FDG PET-CT (disease) positive baseline scan with measurable disease. The patient must have received prior therapy that included: * CD20-targeted therapy...