Prephase Treatment With Prednisone +/- Vitamin D Supplementation Followed by Immunochemotherapy
Status:
Not yet recruiting
Trial end date:
2030-09-01
Target enrollment:
Participant gender:
Summary
This is an open-label, multicenter, randomized phase III trial. The study plans to randomize
patients with a 1 to 1 ratio to Arm A (Standard arm) or Arm B (Experimental arm).
All patients of both arms will receive a prephase with oral prednisone before 6 cycles Q21 of
immunochemotherapy with R-CHOP or R-miniCHOP at standard doses; patients in the Experimental
arm (Arm B) will receive also a prephase therapy with VitD and a supplementation of VitD
during the intere period of immunochemotherapy according to a prefixed schedule. Choice of
type of immunochemotherapy will not rely on Comprehensive Geriatric Assessment result, but
treatment at reduced doses with R-miniCHOP is highly recommended option for UNFIT and FRAIL
patients.