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.
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
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.
| Facility | City | Region | Status |
|---|---|---|---|
| SC Ematologia Spedali Civili | Brescia | BS | Recruiting |
| UO Ematologia e CTMO di Piacenza | Piacenza | PC | Recruiting |
| Ospedale Oncologico regionale CROB | Rionero in Vulture | Piacenza | Not Yet Recruiting |
| A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia | Alessandria | Italy | Recruiting |
| A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona | Ancona | Italy | Recruiting |
| Ascoli Piceno - Ospedale C.e G. Mazzoni - U.O.C. di Ematologia | Ascoli Piceno | Italy | Not Yet Recruiting |
| Aviano - Centro Riferimento Oncologico - S.O.C. Oncologia Medica A | Aviano | Italy | Recruiting |
| Barletta - Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia | Barletta | Italy | Not Yet Recruiting |
| Bergamo - Cliniche Humanitas Gavazzeni - Oncologia - Cliniche Humanitas Gavazzeni | Bergamo | Italy | Not Yet Recruiting |
| Biella - Ospedale Degli Infermi - S.C. Oncologia | Biella | Italy | Not Yet Recruiting |
| Campobasso - Universitа Cattolica del Sacro Cuore - Ematologia | Campobasso | Italy | Not Yet Recruiting |
| Castelfranco Veneto - Ospedale di Castelfranco Veneto - Ematologia | Castelfranco Veneto | Italy | Not Yet Recruiting |
| Unità Funzionale di Ematologia AOU Careggi | Florence | Italy | Recruiting |
| Frosinone - Presidio Ospedaliero F. Spaziani - UOC Ematologia | Frosinone | Italy | Not Yet Recruiting |
| Matera - Ospedale Madonna delle Grazie - Ematologia | Matera | Italy | Not Yet Recruiting |
| Meldola - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) - Ematologia | Meldola | Italy | Recruiting |
| Mestre - Ospedale Dell Angelo - U.O. Ematologia | Mestre | Italy | Not Yet Recruiting |
| SC Ematologia AO Niguarda Cà Granda | Milan | Italy | Not Yet Recruiting |
| Monza - ASST MONZA Ospedale S. Gerardo - Ematologia | Monza | Italy | Recruiting |
| Napoli - AOU Universitа degli Studi della Campania Luigi Vanvitelli - Oncologia Medica ed Ematologia | Naples | Italy | Not Yet Recruiting |
| Università del Piemonte Orientale - Novara | Novara | Italy | Not Yet Recruiting |
| Padova - I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1 | Padova | Italy | Not Yet Recruiting |
| Pagani - Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia | Pagani | Italy | Not Yet Recruiting |
| Palermo - A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia | Palermo | Italy | Not Yet Recruiting |
| Palermo - AOU Policlinico Giaccone - Ematologia | Palermo | Italy | Recruiting |
| UO Ematologia Università - Policlinico San Matteo | Pavia | Italy | Recruiting |
| Pescara - P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi | Pescara | Italy | Not Yet Recruiting |
| Potenza - AOR San Carlo | Potenza | Italy | Not Yet Recruiting |
| UO Ematologia Ospedale Santa Maria delle Croci | Ravenna | Italy | Recruiting |
| Reggio Emilia - AO Santa Maria Nuova | Reggio Emilia | Italy | Recruiting |
| UO Ematologia - Ospedale degli Infermi | Rimini | Italy | Not Yet Recruiting |
| Roma - IRCCS Spallanzani - Servizio di Ematologia in malattie infettive | Roma | Italy | Not Yet Recruiting |
| Roma - Ospedale S. Camillo - Ematologia | Roma | Italy | Not Yet Recruiting |
| Roma - Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare | Roma | Italy | Recruiting |
| Università Cattolica S. Cuore, Ematologia | Roma | Italy | Not Yet Recruiting |
| Università La Sapienza Ematologia | Roma | Italy | Not Yet Recruiting |
| UOC Ematologia - A.O. Sant'Andrea | Roma | Italy | Not Yet Recruiting |
| Salerno - Ematologia e Trapianti A.O. San Giovanni di Dio e Ruggi D Aragona - U.O. Ematologia | Salerno | Italy | Recruiting |
| San Giovanni Rotondo - Casa Sollievo della Sofferenza - U.O. Ematologia | San Giovanni Rotondo | Italy | Not Yet Recruiting |
| Sassari - AOU di Sassari - Ematologia | Sassari | Italy | Not Yet Recruiting |
+ 9 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04442412 on ClinicalTrials.gov ↗ ← All trials in Italy