A Randomized, Multicenter, Phase III Trial Comparing Treatment With R-mini-CHOP With R-mini-CHP + Polatuzumab Vedotin in Patients With Diffuse Large Cell B Cell Lymphoma
Age ≥80 years or frail ≥75 years, according to simplified comprehensive geriatric assessment
Histologically confirmed lymphoma belonging to one of the following subtypes:
1. diffuse large B-cell lymphoma, including transformation from an indolent lymphoma
2. follicular lymphoma grade 3B
3. T-cell/histiocyte-rich LBCL
4. primary cutaneous DLBCL, leg type
5. EBV-positive DLBCL, NOS
6. primary mediastinal LBCL
7. high grade B-cell lymphoma with MYC/BCL2 rearrangement
Stage II-IV disease
At least 1 measurable site of disease (\>1.5 cm long axis)
No previous treatment for lymphoma
WHO performance status 0 - 3 (Grade 3 if related to DLBCL)
Written informed consent
You may not be if
Severe cardiac disease: NYHA grade 3-4
CNS involvement at diagnosis
Uncontrolled serious infection
Impaired liver (transaminases \> 3x normal upper limit or bilirubin \> 1.5 x normal upper limit, unless due to Gilbert´s syndrome) , renal (GFR\<30ml/min) or other organ function not caused by lymphoma, which will interfere with the treatment.
Absolute neutrophil count (ANC) \<1000 cells/µL or platelets \<100,000 cells/µL, unless due to lymphoma
Any other prior malignancy than non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma, unless treated with curative intent, and without relapse since 2 years, or low grade prostate cancer, not in need of treatment
Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study
Known hypersensitivity to rituximab, polatuzumab vedotin, cyclophosphamide, vincristine or doxorubicin, or HACA against rituximab
Peripheral neuropathy grade ≥ 2
Clareo Health | A Randomized, Multicenter, Phase III Trial Comparing Treatment With R-mini-CHOP With R-mini-CHP + Polatuzumab Vedotin in Patients With Diffuse Large Cell B Cell Lymphoma
