Actively Recruiting
Prephase Treatment With Prednisone With or Without Vitamin D Supplementation Followed by Immunochemotherapy in Elderly Patients With Diffuse Large B-Cell Lymphoma
Led by Fondazione Italiana Linfomi - ETS · Updated on 2022-08-26
430
Participants Needed
49
Research Sites
260 weeks
Total Duration
On this page
Sponsors
F
Fondazione Italiana Linfomi - ETS
Lead Sponsor
G
GRADE Onlus
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of adding Vitamin D supplementation to standard immunochemotherapy in elderly patients diagnosed with Diffuse Large B-Cell Lymphoma or Follicular grade IIIb lymphoma. This open-label, randomized phase III trial compares two treatment approaches to understand whether Vitamin D affects outcomes in patients aged 65 and older undergoing immunochemotherapy. Participants are randomly assigned to one of two groups. Both groups receive a prephase of oral prednisone followed by six cycles of immunochemotherapy with R-CHOP or R-miniCHOP every 21 days. The experimental group also receives Vitamin D supplementation starting before treatment and continuing through immunochemotherapy according to a set schedule, including loading doses based on baseline Vitamin D levels and weekly maintenance. Patients may continue Vitamin D supplementation after treatment for up to two years. During the study, participants undergo baseline assessments and are monitored regularly through the treatment cycles. Researchers track progression-free survival over 54 months as the primary outcome, along with overall survival, response rates, Vitamin D levels, physical functioning, and fatigue. Safety and treatment adherence are also monitored, with follow-up visits extending up to several years to evaluate long-term outcomes.
CONDITIONS
Brief Title
Prephase Treatment With Prednisone +/- Vitamin D Supplementation Followed by Immunochemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of Diffuse Large B-Cell Lymphoma or Follicular grade IIIb lymphoma per WHO 2017 classification
- Age 65 years or older
- Comprehensive Geriatric Assessment performed before treatment
- Eastern Cooperative Oncology Group performance status 3 or less
- Eligible for anthracycline-containing regimen (R-CHOP or R-miniCHOP)
- No prior treatment for these lymphomas
- Ann Arbor stage I to IV
- At least one measurable nodal disease site (≥1.5 cm) or metabolically active site by FDG-PET
- Serum Vitamin D levels 40 ng/mL or lower
- Adequate blood counts: neutrophils >1.5 x 10^9/L unless marrow involvement; platelets ≥80,000/mm3 unless marrow involvement
- Adequate kidney function: creatinine ≤2 mg/dL unless due to lymphoma
- Adequate liver function: bilirubin ≤2 mg/dL unless due to lymphoma
- Left ventricular ejection fraction >50%
- Life expectancy of at least 6 months
- Ability to understand and sign informed consent
- Ability to comply with study visits and procedures
- Men agree to use contraception during and for 3 months after treatment and not to donate sperm during the study
You will not qualify if you...
- Diagnosis other than Diffuse Large B-Cell Lymphoma or Follicular grade IIIb lymphoma, including high-grade B-cell lymphoma with MYC, BCL2 and/or BCL6 rearrangements
- Vitamin D supplementation above 10,000 U/week as standard care
- Suspected or confirmed central nervous system involvement by lymphoma
- Contraindication to rituximab use
- Contraindication to Vitamin D supplementation (such as hypercalcemia or hyperphosphatemia)
- Received anti-cancer therapy within 14 days before study drug
- Significant neurological, psychiatric, endocrine, metabolic, immunologic, or liver disease impairing consent or participation
- History of other active cancers within 2 years except certain treated localized cancers
- Clinically significant uncontrolled conditions, including active infections or hepatitis B/C requiring treatment
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for baseline assessments and randomization
Duration - 7 to 14 days
Participants receive a prephase treatment with oral prednisone, with or without Vitamin D supplementation depending on their assigned arm.
1 prephase visit (in-person)
Duration - Approximately 18 weeks
Participants undergo 6 courses of immunochemotherapy with R-CHOP or R-miniCHOP every 21 days. Vitamin D supplementation continues for participants in the experimental arm according to their baseline Vitamin D levels.
6 treatment visits every 21 days
Duration - Up to 2 years
Participants may continue Vitamin D supplementation at a reduced dose monthly for up to 2 years and are followed for survival and treatment outcomes.
Monthly follow-up visits for Vitamin D supplementation and survival monitoring
Trial Site Locations
Total: 49 locations
1
SC Ematologia Spedali Civili
Brescia, BS, Italy
Actively Recruiting
2
UO Ematologia e CTMO di Piacenza
Piacenza, PC, Italy, 29121
Actively Recruiting
3
Ospedale Oncologico regionale CROB
Rionero in Vulture, Piacenza, Italy
Not Yet Recruiting
4
A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia
Alessandria, Italy, 15121
Actively Recruiting
5
A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona
Ancona, Italy, 60126
Actively Recruiting
6
Ascoli Piceno - Ospedale C.e G. Mazzoni - U.O.C. di Ematologia
Ascoli Piceno, Italy, 15121
Not Yet Recruiting
7
Aviano - Centro Riferimento Oncologico - S.O.C. Oncologia Medica A
Aviano, Italy
Actively Recruiting
8
Barletta - Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia
Barletta, Italy
Not Yet Recruiting
9
Bergamo - Cliniche Humanitas Gavazzeni - Oncologia - Cliniche Humanitas Gavazzeni
Bergamo, Italy
Not Yet Recruiting
10
Biella - Ospedale Degli Infermi - S.C. Oncologia
Biella, Italy
Not Yet Recruiting
11
Campobasso - Universitа Cattolica del Sacro Cuore - Ematologia
Campobasso, Italy
Not Yet Recruiting
12
Castelfranco Veneto - Ospedale di Castelfranco Veneto - Ematologia
Castelfranco Veneto, Italy
Not Yet Recruiting
13
Unità Funzionale di Ematologia AOU Careggi
Florence, Italy
Actively Recruiting
14
Frosinone - Presidio Ospedaliero F. Spaziani - UOC Ematologia
Frosinone, Italy
Not Yet Recruiting
15
Matera - Ospedale Madonna delle Grazie - Ematologia
Matera, Italy
Not Yet Recruiting
16
Meldola - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) - Ematologia
Meldola, Italy
Actively Recruiting
17
Mestre - Ospedale Dell Angelo - U.O. Ematologia
Mestre, Italy
Not Yet Recruiting
18
SC Ematologia AO Niguarda Cà Granda
Milan, Italy, 20162
Not Yet Recruiting
19
Monza - ASST MONZA Ospedale S. Gerardo - Ematologia
Monza, Italy
Actively Recruiting
20
Napoli - AOU Universitа degli Studi della Campania Luigi Vanvitelli - Oncologia Medica ed Ematologia
Naples, Italy
Not Yet Recruiting
21
Università del Piemonte Orientale - Novara
Novara, Italy, 28100
Not Yet Recruiting
22
Padova - I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1
Padova, Italy
Not Yet Recruiting
23
Pagani - Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia
Pagani, Italy
Not Yet Recruiting
24
Palermo - A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia
Palermo, Italy
Not Yet Recruiting
25
Palermo - AOU Policlinico Giaccone - Ematologia
Palermo, Italy
Actively Recruiting
26
UO Ematologia Università - Policlinico San Matteo
Pavia, Italy
Actively Recruiting
27
Pescara - P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi
Pescara, Italy
Not Yet Recruiting
28
Potenza - AOR San Carlo
Potenza, Italy
Not Yet Recruiting
29
UO Ematologia Ospedale Santa Maria delle Croci
Ravenna, Italy
Actively Recruiting
30
Reggio Emilia - AO Santa Maria Nuova
Reggio Emilia, Italy, 42123
Actively Recruiting
31
UO Ematologia - Ospedale degli Infermi
Rimini, Italy
Not Yet Recruiting
32
Roma - IRCCS Spallanzani - Servizio di Ematologia in malattie infettive
Roma, Italy
Not Yet Recruiting
33
Roma - Ospedale S. Camillo - Ematologia
Roma, Italy
Not Yet Recruiting
34
Roma - Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare
Roma, Italy
Actively Recruiting
35
Università Cattolica S. Cuore, Ematologia
Roma, Italy
Not Yet Recruiting
36
Università La Sapienza Ematologia
Roma, Italy
Not Yet Recruiting
37
UOC Ematologia - A.O. Sant'Andrea
Roma, Italy
Not Yet Recruiting
38
Salerno - Ematologia e Trapianti A.O. San Giovanni di Dio e Ruggi D Aragona - U.O. Ematologia
Salerno, Italy
Actively Recruiting
39
San Giovanni Rotondo - Casa Sollievo della Sofferenza - U.O. Ematologia
San Giovanni Rotondo, Italy
Not Yet Recruiting
40
Sassari - AOU di Sassari - Ematologia
Sassari, Italy
Not Yet Recruiting
41
UOC Medicina Interna MO DH Oncologico
Sassuolo, Italy
Actively Recruiting
42
UOC Ematologia, AOU Senese
Siena, Italy
Actively Recruiting
43
Univ. Perugia Sede Terni - Oncoematologia
Terni, Italy
Actively Recruiting
44
AOU Citta della Salute e della Scienza di Torino - Ematologia Universitaria
Torino, Italy, 10126
Actively Recruiting
45
SC. Ematologia A.O. Città della Salute e della Scienza
Torino, Italy
Actively Recruiting
46
Torino - San Giovanni Bosco - ASL Cittа di Torino - SSD di Ematologia e Malattie Trombotiche
Torino, Italy
Not Yet Recruiting
47
Trieste - Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia
Trieste, Italy, 34121
Actively Recruiting
48
Udine - Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica
Udine, Italy
Not Yet Recruiting
49
ULSS 8 Berica - Ospedale S. Bortolo - Ematologia
Vicenza, Italy
Actively Recruiting
Research Team
L
Lorenza Randi, Dott.ssa
F
Francesco Merli, Dott.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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