Prephase Treatment With Prednisone +/- Vitamin D Supplementation Followed by Immunochemotherapy

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

Trial Details

NCT ID
NCT04442412
Phase
PHASE3
Sponsor
Fondazione Italiana Linfomi - ETS
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • Vitamin D3 (Cholecalciferol)
  • RCHOP o R-miniCHOP at standard doses
Locations (sample)
  • Brescia, BS, Italy|45.53558,10.21472
  • Piacenza, PC, Italy|45.05242,9.69342
  • Rionero in Vulture, Piacenza, Italy|40.92328,15.6711
  • Alessandria, Italy|44.90924,8.61007
  • Ancona, Italy|43.60717,13.5103

Key Eligibility Criteria

  • Histologically documented diagnosis of Diffuse Large B-cell Lymphoma or Follicular grade IIIb lymphoma, as defined in the 2017 edition of the World…
  • Age ≥ 65 years
  • Comprehensive Geriatric Assessment performed at baseline, before start of any treatment.
  • Eastern Cooperative Oncology Group performance status (PS) ≤3

For full eligibility, visit ClinicalTrials.gov.

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