Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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. PET-CT scan performed after induction be centrally review for disease response. Responding patients (CR) after induction will be addressed to receive Autologous Stem Cells Transplantation (ASCT) consolidation as per local guidelines. Patients achieving PR can proceed with ASCT or with a 3rd-line treatment, according to the physician judgment. Patients in SD/PD will be diverted to salvage strategies. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05966233
Study type Interventional
Source Fondazione Italiana Linfomi - ETS
Contact Uffici Studi FIL
Phone +390131033153
Email startup@filinf.it
Status Not yet recruiting
Phase Phase 2
Start date January 2024
Completion date January 2029

See also
  Status Clinical Trial Phase
Recruiting NCT06033820 - Zanubrutinib+Lenalidomide+R-ICE in Relapsed/Refractory DLBCL Phase 2
Recruiting NCT06086197 - A-RGEMOX in the Treatment of Early Relapsed/Refractory DLBCL Phase 2
Recruiting NCT03795571 - Lenalidomide, Rituximab, Gemcitabine, Oxaliplatin and Dexamethasone in Relapse and Refractory DLBCL Phase 1
Completed NCT05169203 - The Use of Biomarkers to Predict CNS Involvement in Diffuse Large B-Cell Lymphoma: a Danish Nationwide Registry Study
Completed NCT01805557 - Phase II Randomized Study With R-DHAP +/- Bortezomib as Induction Therapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) Patients Eligible to Transplantation. BR-DHAP Versus R-DHAP. Phase 2/Phase 3
Recruiting NCT02955628 - RICE-ibrutinib in Relapsed DLBCL Phase 2
Completed NCT03589469 - Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma Phase 2