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

NCT04442412 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2022-08-26

No results posted yet for this study

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.

Conditions

  • Diffuse Large B-Cell Lymphoma
  • Elderly Patients

Interventions

DRUG

Vitamin D3 (Cholecalciferol)

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.

DRUG

RCHOP o R-miniCHOP at standard doses

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

Sponsors & Collaborators

  • GRADE Onlus

    collaborator OTHER

  • Fondazione Italiana Linfomi - ETS

    lead OTHER

Principal Investigators

  • Francesco Merli, Dott. · Reggio Emilia - Azienda Unitа Sanitaria Locale-IRCCS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-23
Primary Completion
2025-09-01
Completion
2030-09-01
FDA Drug
Yes

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04442412 on ClinicalTrials.gov