Actively Recruiting
Prephase Treatment With Prednisone +/- Vitamin D Supplementation Followed by Immunochemotherapy
Led by Fondazione Italiana Linfomi - ETS · Updated on 2022-08-26
430
Participants Needed
49
Research Sites
492 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 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.
CONDITIONS
Official 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 as defined by WHO 2017
- Age 65 years or older
- Comprehensive Geriatric Assessment completed before treatment
- Eastern Cooperative Oncology Group performance status 3 or less
- Eligible for treatment with R-CHOP or R-miniCHOP regimens
- No prior treatment for DLBCL or Follicular grade IIIb lymphoma
- Ann Arbor stage I to IV disease
- At least one measurable nodal lesion 1.5 cm or larger by CT scan or one metabolically active site by FDG-PET
- Serum vitamin D level 40 ng/ml or less
- Adequate blood counts unless affected by lymphoma involvement
- Absolute neutrophil count greater than 1.5 x 10^9/L unless due to lymphoma
- Platelet count 80,000/mm3 or higher unless due to lymphoma
- Adequate kidney function with creatinine 2 mg/dL or less unless due to lymphoma
- Adequate liver function with bilirubin 2 mg/dL or less unless due to lymphoma
- Left ventricular ejection fraction greater than 50% by echocardiogram
- Life expectancy of at least 6 months
- Ability to understand and provide informed consent
- Ability to follow study visit schedule and protocol requirements
- Men agree to use acceptable contraception during study and for 3 months after last immunochemotherapy dose and not to donate sperm
You will not qualify if you...
- Diagnosis other than Diffuse Large B-Cell Lymphoma or Follicular grade IIIb lymphoma, including HGBL with MYC, BCL2, or BCL6 rearrangements
- Use of vitamin D supplementation exceeding 10,000 units per week
- Suspected or confirmed central nervous system involvement by lymphoma
- Contraindication to rituximab use
- Contraindication to vitamin D supplementation such as hypercalcemia or hyperphosphatemia
- Receipt of any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, or investigational drugs within 14 days before study treatment
- Significant neurological, psychiatric, endocrine, metabolic, immune, or liver diseases that impair study participation or consent
- Any other active cancers within 2 years except certain treated localized cancers
- Uncontrolled or active infections including viral, bacterial, or fungal
- Chronic hepatitis B or C requiring treatment
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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
CONTACT
F
Francesco Merli, Dott.
CONTACT
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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