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.

Who is this study for? Patients with Diffuse Large B-Cell Lymphoma
What treatments are being studied? RCHOP o R-miniCHOP
Status: Recruiting
Location: See all (49) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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

• Eligibility for anthracycline containing regimen (R-CHOP or R-miniCHOP)

• No previous treatment for DLBCL or Follicular grade IIIb lymphoma

• Ann Arbor stage I-IV

• At least one site of measurable nodal disease at baseline ≥ 1.5 cm in the longest transverse diameter as determined by CT scan ; or one metabolic active site of disease at baseline FDG-PET scan

• Serum basic levels of Vitamin D \[25 (OH) VitD\] ≤ 40 ng / ml;

⁃ Adequate hematological counts defined as follows:

∙ Absolute Neutrophil count \> 1.5 x 109/L unless due to bone marrow involvement by lymphoma

‣ Platelet count ≥ 80.000/mm3 unless due to bone marrow involvement by lymphoma

⁃ Adequate renal function defined as follows:

⁃ \- Creatinine ≤ 2 mg/dL, unless secondary to lymphoma

⁃ Adequate hepatic function defined as follows:

⁃ \- Bilirubin ≤ 2 mg/dL unless secondary to lymphoma

⁃ LVEF \> 50% at bidimensionally echocardiogram

⁃ Life expectancy ≥ 6 months

⁃ Subject understands and voluntarily signs an informed consent form approved by an Independent Ethics Committee , prior to the initiation of any screening or study-specific procedures

⁃ Subject must be able to adhere to the study visit schedule and other protocol requirements

⁃ Men must agree to use one of the below reported acceptable method of contraception for the duration of the study and for 3 months after receiving the last dose of immunochemotherapy, and to not donate sperm while on study.

Locations
Other Locations
Italy
A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia
RECRUITING
Alessandria
A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona
RECRUITING
Ancona
Ascoli Piceno - Ospedale C.e G. Mazzoni - U.O.C. di Ematologia
NOT_YET_RECRUITING
Ascoli Piceno
Aviano - Centro Riferimento Oncologico - S.O.C. Oncologia Medica A
RECRUITING
Aviano
Barletta - Ospedale Monsignor Raffaele Dimiccoli - Ematologia
NOT_YET_RECRUITING
Barletta
Bergamo - Cliniche Humanitas Gavazzeni - Oncologia - Cliniche Humanitas Gavazzeni
NOT_YET_RECRUITING
Bergamo
Biella - Ospedale Degli Infermi - S.C. Oncologia
NOT_YET_RECRUITING
Biella
SC Ematologia Spedali Civili
RECRUITING
Brescia
Campobasso - Universitа Cattolica del Sacro Cuore - Ematologia
NOT_YET_RECRUITING
Campobasso
Castelfranco Veneto - Ospedale di Castelfranco Veneto - Ematologia
NOT_YET_RECRUITING
Castelfranco Veneto
Unità Funzionale di Ematologia AOU Careggi
RECRUITING
Florence
Frosinone - Presidio Ospedaliero F. Spaziani - UOC Ematologia
NOT_YET_RECRUITING
Frosinone
Matera - Ospedale Madonna delle Grazie - Ematologia
NOT_YET_RECRUITING
Matera
Meldola - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) - Ematologia
RECRUITING
Meldola
Mestre - Ospedale Dell Angelo - U.O. Ematologia
NOT_YET_RECRUITING
Mestre
SC Ematologia AO Niguarda Cà Granda
NOT_YET_RECRUITING
Milan
Monza - ASST MONZA Ospedale S. Gerardo - Ematologia
RECRUITING
Monza
Napoli - AOU Universitа degli Studi della Campania Luigi Vanvitelli - Oncologia Medica ed Ematologia
NOT_YET_RECRUITING
Napoli
Università del Piemonte Orientale - Novara
NOT_YET_RECRUITING
Novara
Padova - I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1
NOT_YET_RECRUITING
Padua
Pagani - Presidio ospedaliero A. TORTORA - U.O. Onco-ematologia
NOT_YET_RECRUITING
Pagani
Palermo - A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia
NOT_YET_RECRUITING
Palermo
Palermo - AOU Policlinico Giaccone - Ematologia
RECRUITING
Palermo
UO Ematologia Università - Policlinico San Matteo
RECRUITING
Pavia
Pescara - P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi
NOT_YET_RECRUITING
Pescara
UO Ematologia e CTMO di Piacenza
RECRUITING
Piacenza
Potenza - AOR San Carlo
NOT_YET_RECRUITING
Potenza
UO Ematologia Ospedale Santa Maria delle Croci
RECRUITING
Ravenna
Reggio Emilia - AO Santa Maria Nuova
RECRUITING
Reggio Emilia
UO Ematologia - Ospedale degli Infermi
NOT_YET_RECRUITING
Rimini
Ospedale Oncologico regionale CROB
NOT_YET_RECRUITING
Rionero In Vulture
Roma - IRCCS Spallanzani - Servizio di Ematologia in malattie infettive
NOT_YET_RECRUITING
Roma
Roma - Ospedale S. Camillo - Ematologia
NOT_YET_RECRUITING
Roma
Roma - Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare
RECRUITING
Roma
Università Cattolica S. Cuore, Ematologia
NOT_YET_RECRUITING
Roma
Università La Sapienza Ematologia
NOT_YET_RECRUITING
Roma
UOC Ematologia - A.O. Sant'Andrea
NOT_YET_RECRUITING
Roma
Salerno - Ematologia e Trapianti A.O. San Giovanni di Dio e Ruggi D Aragona - U.O. Ematologia
RECRUITING
Salerno
San Giovanni Rotondo - Casa Sollievo della Sofferenza - U.O. Ematologia
NOT_YET_RECRUITING
San Giovanni Rotondo
Sassari - AOU di Sassari - Ematologia
NOT_YET_RECRUITING
Sassari
UOC Medicina Interna MO DH Oncologico
RECRUITING
Sassuolo
UOC Ematologia, AOU Senese
RECRUITING
Siena
Univ. Perugia Sede Terni - Oncoematologia
RECRUITING
Terni
AOU Citta della Salute e della Scienza di Torino - Ematologia Universitaria
RECRUITING
Torino
SC. Ematologia A.O. Città della Salute e della Scienza
RECRUITING
Torino
Torino - San Giovanni Bosco - ASL Cittа di Torino - SSD di Ematologia e Malattie Trombotiche
NOT_YET_RECRUITING
Torino
Trieste - Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia
RECRUITING
Trieste
Udine - Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica
NOT_YET_RECRUITING
Udine
ULSS 8 Berica - Ospedale S. Bortolo - Ematologia
RECRUITING
Vicenza
Contact Information
Primary
Lorenza Randi, Dott.ssa
lrandi@filinf.it
0000000000
Backup
Francesco Merli, Dott.
startup@filinf.it
0000000000
Time Frame
Start Date: 2021-03-23
Estimated Completion Date: 2030-09-01
Participants
Target number of participants: 430
Treatments
Experimental: Arm B (Experimental):
Patients randomized to Arm B will receive a prephase with oral prednisone and a prephase therapy with VitD according to the below reported schedule followed by 6 courses of R-CHOP or R-miniCHOP every 21 days.~Schedule for VitD supplementation: 25,000 U/day starting on day -6:~daily loading dose for 7 days if 25 VitD baseline level 20-40 ng/ml daily loading dose for 14 days if 25 VitD baseline level \< 20 ng/ml followed by weekly maintenance supplementation of 25,000 U for the entire duration of immunochemotherapy (6 courses every 21 days - 18 weeks), regardless of the baseline level of 25 VitD.
Other: Arm A (Standard arm)
Patients randomized to Arm A will receive a prephase with oral prednisone followed by 6 courses of R-CHOP or R-miniCHOP every 21 days.~If patients randomized to arm A are already on VitD, they are allowed to continue receiving VitD supplementation at a dose that can be considered part of the standard of care and does not exceed the maximum standard VitD dose recommended for general adult and elderly population , up to 10,000 U/week VitD
Sponsors
Leads: Fondazione Italiana Linfomi - ETS
Collaborators: GRADE Onlus

This content was sourced from clinicaltrials.gov

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