COALITION : A Multicentre Trial of Frontline R-CHOP/Pola-RCHP and Glofitamab in Younger, Higher Risk Patients With Diffuse Large B Cell Lymphoma (DLBCL)

Trial Identifiers

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• NCT04914741

Scientific Title

A Multicentre Trial of Frontline R-CHOP/Pola-RCHP and Glofitamab in Younger, Higher Risk Patients With Diffuse Large B Cell Lymphoma (DLBCL)

Commercial Sponsor

Hoffmann-La Roche

Other Non-Commercial Sponsor

National Health Service Blood & Transplant

Summary

This randomised trial has two experimental arms. In Experimental Arm 1, participants will receive Glofitamab plus R-CHOP. Participants will receive treatment in 21 day cycles consisting of R-CHOP in cycle 1, followed by R-CHOP plus glofitamab for cycles 2-6, and two cycles of glofitamab monotherapy consolidation. Patients may also receive high-dose methotrexate CNS prophylaxis at investigator discretion. Rituximab 375 mg/m^2 will be administered by IV infusion on Day 1 of every 21-day cycle. Cyclophosphamide 750mg/m^2 will be administered by IV infusion on Day 1 of every 21-day cycle. Doxorubicin 50mg/m^2 will be administered by IV infusion on Day 1 of every 21-day cycle. Vincristine 1.4mg/m^2 will be administered by IV infusion on Day 1 of every 21-day cycle. Prednisolone 100mg will be administered orally on Days 1-5 of every 21-day cycle. Glofitamab will be administered by IV infusion as per the schedule specified in the respective arm. In Experimental Arm 2, participants will receive Glofitamab plus polatuzumab vedotin-RCHP. Participants will receive treatment in 21 day cycles consisting of R-CHOP in cycle 1, followed by polatuzumab vedotin-RCHP plus glofitamab for cycles 2-6, and two cycles of glofitamab monotherapy consolidation. Patients may also receive high-dose methotrexate CNS prophylaxis at investigator discretion. Rituximab 375 mg/m^2 will be administered by IV infusion on Day 1 of every 21-day cycle. Cyclophosphamide 750mg/m^2 will be administered by IV infusion on Day 1 of every 21-day cycle. Doxorubicin 50mg/m^2 will be administered by IV infusion on Day 1 of every 21-day cycle. Prednisolone 100mg will be administered orally on Days 1-5 of every 21-day cycle. Glofitamab will be administered by IV infusion as per the schedule specified in the respective arm.