Prephase Treatment With Prednisone +/- Vitamin D Supplementation Followed by Immunochemotherapy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age65+
SponsorFondazione Italiana Linfomi - ETS
About this trial
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.
Eligibility criteria
Qualifiers
Histologically documented diagnosis of Diffuse Large B-cell Lymphoma or Follicular grade IIIb lymphoma, as defined in the 2017 edition of the World Health Organization (WHO) classification.
Age ≥ 65 years
Comprehensive Geriatric Assessment performed at baseline, before start of any treatment.
Eastern Cooperative Oncology Group performance status (PS) ≤3
Disqualifiers
Histological diagnosis different from Diffuse large B-Cell Lymphoma or Follicular grade IIIb lymphoma, including diagnosis of HGBL, with rearrangement of MYC, BCL2 and/or BCL6 (double-hit)
Use of VitD supplementation as standard of care at dose higher than 10,000 U/week
Suspect or clinical evidence of CNS involvement by lymphoma
Contraindication to the use of rituximab
Trial design
Treatments tested in this trial
- Vitamin D3 (Cholecalciferol)
- RCHOP o R-miniCHOP at standard doses
Treatment groups
430 Participants
are divided into 2 treatment groupsSponsors and collaborators
Fondazione Italiana Linfomi - ETS
Lead sponsor
GRADE Onlus
Collaborator
Source ClinicalTrials.gov