drugset
drugset / Trial / NCT05966233

R-DHAP vs POLA-R-DHAP Followed by Autologous Transplant as First Salvage Treatment in Patient With Relapsed or Refractory Diffuse Large B Cell Lymphoma

NCT05966233 ↗

Phase 2 Withdrawn Fondazione Italiana Linfomi - ETS Roche Pharma AG · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

Prospective, multicenter, open label, phase II randomized clinical trial in DLBCL patients relapsed or refractory to first line R-chemo, aged 18-70 years and candidate to autologous transplant. Patients will be randomized 1:1 to received 4 cycles of R-DHAP or R-DHAP plus Polatuzumab Vedotin as induction treatment plus autologous transplant.

Timeline

Start
2024-01
Primary completion
2029-01
Completion
2029-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Polatuzumab Vedotin Other / unclassified 1.8 mg/kg Intravenous
Background Cisplatin Other / unclassified 100 mg/m2 Intravenous
Background Cytarabine Small molecule 2 g Intravenous
Background Dexamethasone Small molecule 40 mg Intravenous
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous

Indications

diffuse large B-cell lymphoma