RecruitingPhase 3NCT04442412

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

Prephase Treatment With Prednisone +/- Vitamin D Supplementation Followed by Immunochemotherapy in Elderly Patients With Diffuse Large B-Cell Lymphoma (DLBCL) A Randomized, Open Label, Phase III Study by Fondazione Italiana Linfomi.

Sponsor

Fondazione Italiana Linfomi - ETS

Enrollment

430 participants

Start Date

Mar 23, 2021

Study Type

INTERVENTIONAL

Conditions

Diffuse Large B Cell Lymphoma Elderly Patients

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.

Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a short course of steroids (prednisone) before immunotherapy, with or without vitamin D, improves the effectiveness and tolerability of treatment for a specific type of lymphoma. **You may be eligible if...** - You have been diagnosed with a specific type of lymphoma being treated with immunotherapy - You are 18 or older - You are medically fit enough to receive immunotherapy **You may NOT be eligible if...** - You have serious infections or conditions that prevent use of steroids - You are pregnant or breastfeeding - You have uncontrolled diabetes or other conditions worsened by steroids Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVitamin 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.

DRUGRCHOP 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

Locations(49)

SC Ematologia Spedali Civili

Brescia, BS, Italy

UO Ematologia e CTMO di Piacenza

Piacenza, PC, Italy

Ospedale Oncologico regionale CROB

Rionero in Vulture, Piacenza, Italy

A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia

Alessandria, Italy

A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona

Ancona, Italy

Ascoli Piceno - Ospedale C.e G. Mazzoni - U.O.C. di Ematologia

Ascoli Piceno, Italy

Aviano - Centro Riferimento Oncologico - S.O.C. Oncologia Medica A

Aviano, Italy

Barletta - Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia

Barletta, Italy

Bergamo - Cliniche Humanitas Gavazzeni - Oncologia - Cliniche Humanitas Gavazzeni

Bergamo, Italy

Biella - Ospedale Degli Infermi - S.C. Oncologia

Biella, Italy

Campobasso - Universitа Cattolica del Sacro Cuore - Ematologia

Campobasso, Italy

Castelfranco Veneto - Ospedale di Castelfranco Veneto - Ematologia

Castelfranco Veneto, Italy

Unità Funzionale di Ematologia AOU Careggi

Florence, Italy

Frosinone - Presidio Ospedaliero F. Spaziani - UOC Ematologia

Frosinone, Italy

Matera - Ospedale Madonna delle Grazie - Ematologia

Matera, Italy

Meldola - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) - Ematologia

Meldola, Italy

Mestre - Ospedale Dell Angelo - U.O. Ematologia

Mestre, Italy

SC Ematologia AO Niguarda Cà Granda

Milan, Italy

Monza - ASST MONZA Ospedale S. Gerardo - Ematologia

Monza, Italy

Napoli - AOU Universitа degli Studi della Campania Luigi Vanvitelli - Oncologia Medica ed Ematologia

Naples, Italy

Università del Piemonte Orientale - Novara

Novara, Italy

Padova - I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1

Padova, Italy

Pagani - Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia

Pagani, Italy

Palermo - A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia

Palermo, Italy

Palermo - AOU Policlinico Giaccone - Ematologia

Palermo, Italy

UO Ematologia Università - Policlinico San Matteo

Pavia, Italy

Pescara - P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi

Pescara, Italy

Potenza - AOR San Carlo

Potenza, Italy

UO Ematologia Ospedale Santa Maria delle Croci

Ravenna, Italy

Reggio Emilia - AO Santa Maria Nuova

Reggio Emilia, Italy

UO Ematologia - Ospedale degli Infermi

Rimini, Italy

Roma - IRCCS Spallanzani - Servizio di Ematologia in malattie infettive

Roma, Italy

Roma - Ospedale S. Camillo - Ematologia

Roma, Italy

Roma - Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare

Roma, Italy

Università Cattolica S. Cuore, Ematologia

Roma, Italy

Università La Sapienza Ematologia

Roma, Italy

UOC Ematologia - A.O. Sant'Andrea

Roma, Italy

Salerno - Ematologia e Trapianti A.O. San Giovanni di Dio e Ruggi D Aragona - U.O. Ematologia

Salerno, Italy

San Giovanni Rotondo - Casa Sollievo della Sofferenza - U.O. Ematologia

San Giovanni Rotondo, Italy

Sassari - AOU di Sassari - Ematologia

Sassari, Italy

UOC Medicina Interna MO DH Oncologico

Sassuolo, Italy

UOC Ematologia, AOU Senese

Siena, Italy

Univ. Perugia Sede Terni - Oncoematologia

Terni, Italy

AOU Citta della Salute e della Scienza di Torino - Ematologia Universitaria

Torino, Italy

SC. Ematologia A.O. Città della Salute e della Scienza

Torino, Italy

Torino - San Giovanni Bosco - ASL Cittа di Torino - SSD di Ematologia e Malattie Trombotiche

Torino, Italy

Trieste - Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia

Trieste, Italy

Udine - Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica

Udine, Italy

ULSS 8 Berica - Ospedale S. Bortolo - Ematologia

Vicenza, Italy

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NCT04442412

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