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

Launched by NORDIC LYMPHOMA GROUP · Apr 1, 2020

Keywords

ClinConnect Summary

This clinical trial is testing two different treatment plans for elderly patients with a type of cancer called diffuse large B-cell lymphoma (DLBCL), which is a serious form of lymphoma. The study aims to see if adding a new drug called polatuzumab vedotin to the standard treatment (R-mini-CHOP) can improve outcomes for patients. Eligible participants are generally those aged 75 and older who are considered frail, or anyone aged 80 and above, and who have not received any previous treatment for their lymphoma. They must also have a confirmed diagnosis of DLBCL or certain related types of lymphoma.

Patients who join the study will be randomly assigned to receive either the standard treatment or the new combination treatment for about 18 weeks. They will be closely monitored during this time and will have follow-up visits for up to three years after completing the treatment. It's important to note that there are specific health conditions that may prevent someone from participating, such as severe heart issues or certain organ problems. Overall, this trial aims to find better treatment options for older patients facing this challenging illness.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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