Condition: Diffuse Large B-Cell Lymphoma · Elderly Patients · Sponsor: Fondazione Italiana Linfomi - ETS
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.
This description comes directly from the study's public registry record.
Lorenza Randi, Dott.ssa · 0000000000 · lrandi@filinf.it
Francesco Merli, Dott. · 0000000000 · startup@filinf.it
Always discuss trial participation with your own doctor first.
| SC Ematologia Spedali Civili | Brescia, BS, Italy | Recruiting |
| UO Ematologia e CTMO di Piacenza | Piacenza, PC, Italy | Recruiting |
| Ospedale Oncologico regionale CROB | Rionero in Vulture, Piacenza, Italy | 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 |
+ 37 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04442412