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

ConditionsDiffuse Large B-Cell Lymphoma Elderly Patients

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Vitamin D3 (Cholecalciferol)
Drug
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 (CGA) result, but treatment at reduced doses with R-miniCHOP is highly recommended option for UNFIT and FRAIL patients.
RCHOP o R-miniCHOP at standard doses
Drug
Patients on both arms receive pre-treatment with prednisone oral before 6 cycles of 21 days each of immunochemotherapy with RCHOP o R-miniCHOP at standard doses

Treatment groups

430 Participants

are divided into 2 treatment groups

Group A: Arm B (Experimental):Experimental treatment 2 interventions

Group B: Arm A (Standard arm)Other 1 intervention