NCT04332822

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

R-MINI-CHOP Versus R-MINI-CHP in Combination With Polatuzumab-vedotin, as Primary Treatment for Patients With Diffuse Large B-cell Lymphoma, ≥80 Years, or Frail ≥75 Years - an Open Label Randomized Nordic Lymphoma Group Phase III Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Nordic Lymphoma Group · Network
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase III, randomized, open-label, multicenter trial, conducted in Sweden, Norway, Finland, Denmark, Italy, Australia and New Zealand, in elderly patients with untreated diffuse large B-cell lymphoma. Elderly is defined as either ≥80 years of age, or ≥75 years and frail, according to a simplified Comprehensive Geriatric Assessment. Patients will be randomized 1:1 to either the standard treatment for this population, R-miniCHOP, or an experimental regimen, R-pola-miniCHP, where vincristine is substituted by an immunoconjugate, polatuzumab vedotin. The duration of the screening period is up to 4 weeks. The duration of active treatment is 18 weeks in both arms, and patients will be followed up to 36 months after end of treatment. Start of enrollment is planned in Q1 2020, and the last visit of the last patient included (end of trial) is estimated in Q1 2027.

Conditions

• DLBCL
• Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	R-pola-mini-CHP	* Rituximab 375 mg/m2 iv, day 1, cycle 1. 1400 mg s c OR 375 mg/m2 iv cycles 2-6 * Cyclophosphamide 400 mg/m2 iv, day 1, cycles 1-6 * Doxorubicin 25 mg/m2 iv , day 1, cycles 1-6 * Prednisone, 40 mg/m2 po, days 1-5, cycles 1-6 - round up to nearest 25 mg * Polatuzumab vedotin 1.8 mg/kg iv day 1 cycles 1-6
DRUG	R-mini-CHOP	* Rituximab 375 mg/m2 i.v., day 1, cycle 1. 1400 mg s c OR 375 mg/m2 i. v. cycles 2-6 * Cyclophosphamide 400 mg/m2 i.v., day 1, cycles 1-6 * Doxorubicin 25 mg/m2 i.v., day 1, cycles 1-6 * Vincristine 1 mg i.v. (total dose), day 1, cycles 1-6 * Prednisone, 40 mg/m2 p.o, days 1-5, , cycles 1-6

Timeline

• Start date: 2020-08-19
• Primary completion: 2025-12-28
• Completion: 2028-12-28
• First posted: 2020-04-03
• Last updated: 2024-09-19

Locations

69 sites across 7 countries: Australia, Denmark, Finland, Italy, New Zealand, Norway, Sweden