Summary
This study is recruiting elderly patients (defined as either ≥80 years of age, or ≥75 years and frail) with previously untreated diffuse large B-cell lymphoma, including the following subtypes:
- diffuse large b-cell lymphoma, including transformation from an indolent lymphoma
- follicular lymphoma grade 3B
- T-cell/histiocyte-rich LBCL
- primary cutaneous BLBCL, leg type
- EBV-positive DLBCL, NOS
- primary mediastinal LBCL
- high grade B-cell lymphoma with MYC/BCL2 rearrangement
Eligible participants will be randomly allocated into one of two treatment arms.
In Arm A, participants will receive standard treatment of R-miniCHOP. This consists of a targeted therapy called rituximab, chemotherapies called cyclophosphamide, doxorubicin and vincristine, and a steroid called prednisone.
In Arm B, participants will receive the experimental regimen of R-pola-miniCHP). This consists of rituximab targeted therapy, cyclophosphamide and doxorubicin chemotherapies, the steroid prednisone and the immuno-conjugate targeted therapy called polatuzumab vedotin.
All treatments will be given intravenously, except the steroid prednisone which will be given orally.
The duration of the study screening period is up to 4 weeks. The duration of active treatment is 18 weeks in both study arms, and participants will be followed up to 36 months after end of treatment. Start of enrollment is planned for Q1 2020 and the last visit of the last patient included (end of trial) is estimated in Q1 2027.