Study to Evaluate Combined Treatment of Daratumumab, Bortezomib and Dexamethasone in PBL P
It is an open-label, multicenter, phase II, single arm trial to Evaluate Activity and Safety of Daratumumab in combination with Bortezomib and Dexamethasone in patients about 28 patients with Relapsed or Refractory Plasmablastic lymphoma.
| Condition(s) | Plasmablastic Lymphoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | It is an open-label, multicenter, phase II, single arm trial to Evaluate Activity and Safety of Daratumumab in combination with Bortezomib and Dexamethasone in patients about 28 patients with Relapsed or Refractory Plasmablastic lymphoma. |
| Who can participate | Inclusion Criteria: 1. Histologically confirmed plasmablastic lymphoma according to WHO 2017, CD38-positive by immunohistochemistry (≥5% of positive cells) Local diagnosis of PBL and local CD38 assessment ≥5% will suffice for enrollment and start of treatment. 2. Patients with plasmablastic lymphoma relapsed or refractory: * after at least one line of conventional-dose chemotherapy followed or not by autologous stem cell transplantation; * after at least one line of conventional-dose chemotherapy and not eligible for salvage autologous or allogeneic transplantation; 3. ECOG Performance Status ≤ 3; 4. Age ≥ 18 years; 5. Both HIV-negative and HIV-positive patients are eligible; 6. HIV infection responsive to ongoing cART (combination antiretroviral therapy); 7. At least one measurable diseas |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Fondazione Italiana Linfomi - ETS |
| Locations | Ancona, Italy; Aviano, Italy; Brescia, Italy; Florence, Italy; Miano, Italy; Milan, Italy (+12 more sites) |
| Start date | 2022-07-11 |
| NCT ID | NCT04915248 |
| Official listing | https://clinicaltrials.gov/study/NCT04915248 |