Study to Evaluate Combined Treatment of Daratumumab, Bortezomib and Dexamethasone in PBL Patients.

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.

Trial Details

NCT ID
NCT04915248
Phase
PHASE2
Sponsor
Fondazione Italiana Linfomi - ETS
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • Daratumumab
  • Bortezomib
  • Dexamethasone
Locations (sample)
  • Ancona, Ancona, Italy|43.60717,13.5103
  • Aviano, Aviano, Italy|46.07056,12.59472
  • Florence, Firenze, Italy|43.77925,11.24626
  • Miano, Italy, Italy|40.88816,14.25339
  • Monza, Italy, Italy|45.58005,9.27246

Key Eligibility Criteria

  • Histologically confirmed plasmablastic lymphoma according to WHO 2017, CD38-positive by immunohistochemistry (≥5% of positive cells) Local diagnosi…
  • 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;

For full eligibility, visit ClinicalTrials.gov.

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