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AzTrials

Diffuse Large B-Cell LymphomaPhase 3FIL_PREVIDNCT04442412

Prephase Treatment With Prednisone +/- Vitamin D Supplementation Followed by Immunochemotherapy

A Phase 3 study testing Vitamin D3 (Cholecalciferol) and RCHOP o R-miniCHOP at standard doses in people with Diffuse Large B-Cell Lymphoma and Elderly Patients, run by Fondazione Italiana Linfomi - ETS at 49 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Vitamin D3 (Cholecalciferol) and RCHOP o R-miniCHOP at standard doses
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
430 participants
Where
49 sitesItaly
Study dates
23 Mar 2021to 1 Sep 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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
Show all 21Show fewer
  • 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.

Who cannot join

  • Histological diagnosis different from Diffuse large B-Cell Lymphoma or Follicular grade IIIb lymphoma, including diagnosis of HGBL, with rearrangement of MYC, BCL2 and/or BCL6 (double-hit)
  • Use of VitD supplementation as standard of care at dose higher than 10,000 U/week
  • Suspect or clinical evidence of CNS involvement by lymphoma
  • Contraindication to the use of rituximab
  • Contraindication to the use of VitD supplementation (Hypercalcemia/Hyperphosphatemia)
  • Subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, investigational therapy, including targeted small molecule agents within 14 days prior to the first dose of study drug
Show all 11Show fewer
  • Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent
  • Any history of other active malignancies within 2 years prior to study entry, with the exception of adequately treated in situ carcinoma of the cervix uterine, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin or limited stage surgically removed breast cancer or adequately treated with radiation therapy or limited stage prostate carcinoma surgically removed or adequately treated with radiation therapy or previous malignancy confined and surgically resected with curative intent
  • Evidence of other clinically significant uncontrolled condition including, but not limited to:
  • Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
  • Chronic hepatitis B virus or hepatitis C requiring treatment.

Trial locations and contacts

49 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lorenza Randi, Dott.ssa contact

0000000000

lrandi@filinf.it

Francesco Merli, Dott. contact

0000000000

startup@filinf.it

49 sites in 1 country

Italy49 sites, 49 recruiting

  • A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia

    Alessandria, 15121

    Manuela Zanni, MD, manuela.zanni@ospedale.al.it

    Maria Vittoria Sacchi, mariavittoria.sacchi@ospedale.al.it

    Recruiting

  • A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona

    Ancona, 60126

    Guido Gini, g.gini@ospedaliriuniti.marche.it

    Alessandra Barucca, alessandra.barucca@gmail.com

    Recruiting

  • Ascoli Piceno - Ospedale C.e G. Mazzoni - U.O.C. di Ematologia

    Ascoli Piceno, 15121

    Piero Galieni, MD, piero.galieni@sanita.marche.it

    Pietro Galieni, MD

    Not yet recruiting

  • Aviano - Centro Riferimento Oncologico - S.O.C. Oncologia Medica A

    Aviano

    Michele Spina, MD, mspina@cro.it

    Michele Spina, MD

    Recruiting

  • Barletta - Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia

    Barletta

    Giuseppe Tarantini, MD, giuseppetarantini0@gmail.com

    Giuseppe Tarantini, MD

    Not yet recruiting

  • Bergamo - Cliniche Humanitas Gavazzeni - Oncologia - Cliniche Humanitas Gavazzeni

    Bergamo

    Serena Camilla Dalto, serena.dalto@gavazzeni.it

    Serena Camilla Dalto, MD

    Not yet recruiting

  • Biella - Ospedale Degli Infermi - S.C. Oncologia

    Biella

    Annarita Conconi, MD, annarita.conconi@aslbi.piemonte.it

    Annarita Conconi, MD

    Not yet recruiting

  • SC Ematologia Spedali Civili

    Brescia, BS

    Alessandra Tucci, alessandra.tucci@ospedalicivili.brescia.it

    Alessandra Tucci, MD

    Recruiting

  • Campobasso - Universitа Cattolica del Sacro Cuore - Ematologia

    Campobasso

    Sergio Storti, MD, sergio.storti@unicatt.it

    Sergio Storti, MD

    Not yet recruiting

  • Castelfranco Veneto - Ospedale di Castelfranco Veneto - Ematologia

    Castelfranco Veneto

    Roberto Sartori, MD, roberto.sartori@iov.veneto.it

    Roberto Sartori, MD

    Not yet recruiting

  • Unità Funzionale di Ematologia AOU Careggi

    Florence

    Benedetta Puccini, MD, puccinib@aou-careggi.toscana.it

    Benedetta Puccini, MD

    Recruiting

  • Frosinone - Presidio Ospedaliero F. Spaziani - UOC Ematologia

    Frosinone

    Gabriella Tomei, MD, gintomei@gmail.com

    Gabriella Tomei, MD

    Not yet recruiting

  • Matera - Ospedale Madonna delle Grazie - Ematologia

    Matera

    Clara Mannarella, MD, clara.mannarella@virgilio.it

    Clara Mannarella, MD

    Not yet recruiting

  • Meldola - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) - Ematologia

    Meldola

    Fabio Augello, MD, accursio.augello@irst.emr.it

    Fabio Augello, MD

    Recruiting

  • Mestre - Ospedale Dell Angelo - U.O. Ematologia

    Mestre

    Renato Bassan, MD, renato.bassan@aulss3.veneto.it

    Renato Bassan, MD

    Not yet recruiting

  • SC Ematologia AO Niguarda Cà Granda

    Milan, 20162

    Emanuele Ravano, MD, emanuele.ravano@ospedaleniguarda.it

    Isabella Ghislandi, isabella.ghislandi@ospedaleniguarda.it

    Not yet recruiting

  • Monza - ASST MONZA Ospedale S. Gerardo - Ematologia

    Monza

    Ivana Casaroli, MD, ivanacasaroli@yahoo.it

    Ivana Casaroli, MD

    Recruiting

  • Napoli - AOU Universitа degli Studi della Campania Luigi Vanvitelli - Oncologia Medica ed Ematologia

    Naples

    Antonello Sica, MD, antonello.sica@fastwebnet.it

    Antonello Sica, MD

    Not yet recruiting

  • Università del Piemonte Orientale - Novara

    Novara, 28100

    Gianluca Gaidano, MD, 0321/660655, gianluca.gaidano@med.uniupo.it

    Clara Deambrogi, clara.deambrogi@med.uniupo.it

    Not yet recruiting

  • Padova - I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1

    Padova

    Dario Marino, MD, dario.marino@iov.veneto.it

    Dario Marino, MD

    Not yet recruiting

  • Pagani - Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia

    Pagani

    Catello Califano, MD, c.califano@aslsalerno.it

    Catello Califano, MD

    Not yet recruiting

  • Palermo - A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia

    Palermo

    Caterina Patti, MD, k.patti@villasofia.it

    Caterina Patti, MD

    Not yet recruiting

  • Palermo - AOU Policlinico Giaccone - Ematologia

    Palermo

    Salvatrice Mancuso, MD, salvatrice.mancuso@unipa.it

    Salvatrice Mancuso, MD

    Recruiting

  • UO Ematologia Università - Policlinico San Matteo

    Pavia

    Luca Arcaini, MD, luca.arcaini@unipv.it

    Luca Arcaini, MD

    Recruiting

  • Pescara - P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi

    Pescara

    Elsa Pennese, MD, elsapennese@gmail.com

    Stefania Luciani, stefyluciani@gmail.com

    Not yet recruiting

  • UO Ematologia e CTMO di Piacenza

    Piacenza, PC, 29121

    Annalisa Arcari, MD, a.arcari@ausl.pc.it

    Annalisa Arcari, MD

    Recruiting

  • Potenza - AOR San Carlo

    Potenza

    Michele Cimminiello, MD, miki-doc@virgilio.it

    Michele Ciminiello, MD

    Not yet recruiting

  • UO Ematologia Ospedale Santa Maria delle Croci

    Ravenna

    Monica Tani, MD, monica.tani@auslromagna.it

    Monica Tani, MD

    Recruiting

  • Reggio Emilia - AO Santa Maria Nuova

    Reggio Emilia, 42123

    Francesco Merli, MD, 0522-296618, merli.francesco@asmn.re.it

    Caterina Mammi, mammi.caterina@ausl.re.it

    Recruiting

  • UO Ematologia - Ospedale degli Infermi

    Rimini

    Anna Lia Molinari, MD, annalia.molinari@auslromagna.it

    Anna Lia Molinari, MD

    Not yet recruiting

  • Ospedale Oncologico regionale CROB

    Rionero in Vulture, Piacenza

    Giuseppe Pietrantuono, MD, ematologia45@alice.it

    Giuseppe Pietrantuono, MD

    Not yet recruiting

  • Roma - IRCCS Spallanzani - Servizio di Ematologia in malattie infettive

    Roma

    Michele Bibas, MD, michele.bibas@inmi.it

    Michele Bibas, MD

    Not yet recruiting

  • Roma - Ospedale S. Camillo - Ematologia

    Roma

    Luigi Rigacci, MD, lrigacci@scamilloforlanini.rm.it

    Luigi Rigacci, MD

    Not yet recruiting

  • Roma - Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare

    Roma

    Ombretta Annibali, MD, o.annibali@unicampus.it

    Ombretta Annibali, MD

    Recruiting

  • Università Cattolica S. Cuore, Ematologia

    Roma

    Stefan Hohaus, MD, stefan.hohaus@Unicatt.it

    Stefan Hohaus, MD

    Not yet recruiting

  • Università La Sapienza Ematologia

    Roma

    Alice Di Rocco, MD, dirocco@bce.uniroma1.it

    Alice Di Rocco, MD

    Not yet recruiting

  • UOC Ematologia - A.O. Sant'Andrea

    Roma

    Agostino Tafuri, MD, 0633775113, agostino.tafuri@ospedalesantandrea.it

    Agostino Tafuri, MD

    Not yet recruiting

  • Salerno - Ematologia e Trapianti A.O. San Giovanni di Dio e Ruggi D Aragona - U.O. Ematologia

    Salerno

    Carmine Selleri, MD, cselleri@unisa.it

    Carmine Selleri, MD

    Recruiting

  • San Giovanni Rotondo - Casa Sollievo della Sofferenza - U.O. Ematologia

    San Giovanni Rotondo

    Nicola Cascavilla, MD, n.cascavilla@operapadrepio.it

    Nicola Cascavilla, MD

    Not yet recruiting

  • Sassari - AOU di Sassari - Ematologia

    Sassari

    Claudio Fozza, MD, cfozza@uniss.it

    Claudio Fozza, MD

    Not yet recruiting

  • UOC Medicina Interna MO DH Oncologico

    Sassuolo

    Sara Bigliardi, MD, s.bigliardi@ausl.mo.it

    Sara Bigliardi, MD

    Recruiting

  • UOC Ematologia, AOU Senese

    Siena

    Alberto Fabbri, MD, a.fabbri@ao-siena.toscana.it

    Cristiana Cafarelli, cristianacafarelli21@gmail.com

    Recruiting

  • Univ. Perugia Sede Terni - Oncoematologia

    Terni

    Anna Marina Liberati, MD, marina.liberati@unipg.it

    Anna Marina Liberati, MD

    Recruiting

  • AOU Citta della Salute e della Scienza di Torino - Ematologia Universitaria

    Torino, 10126

    Federica Cavallo, MD, +39 0116334264, f.cavallo@unito.it

    Luca Palumbo

    Recruiting

  • SC. Ematologia A.O. Città della Salute e della Scienza

    Torino

    Barbara Botto, MD, bbotto@cittadellasalute.to.it

    Giorgio Priolo

    Recruiting

  • Torino - San Giovanni Bosco - ASL Cittа di Torino - SSD di Ematologia e Malattie Trombotiche

    Torino

    Federica De marco, MD, federica.demarco@aslcittaditorino.it

    Federica De marco, MD

    Not yet recruiting

  • Trieste - Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia

    Trieste, 34121

    Francesco Zaja, MD, francesco.zaja@asuits.sanita.fvg.it

    Marta De Piccoli, martadepiccoli1810@gmail.com

    Recruiting

  • Udine - Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica

    Udine

    Jacopo Olivieri, MD, jacopo.olivieri@hotmail.it

    Cristina D'Odorico, cristina.dodorico@asuiud.sanita.fvg.it

    Not yet recruiting

  • ULSS 8 Berica - Ospedale S. Bortolo - Ematologia

    Vicenza

    Maria Chiara Tisi, MD, mariachiara.tisi@aulss8.veneto.it

    Maria Chiara Tisi, MD

    Recruiting

Other trials in Italy

About this study

Official title: 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.

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.

Read the detailed description

After the patient signs the written informed consent the patient will enter the screening phase planning baseline assessments and will be randomly allocated with a 1 to 1 ratio to Arm A (Standard arm) or Arm B (Experimental arm).

Patients randomized to Arm A will receive a prephase with oral prednisone (50 mg for 7 days [day -6 to day 0]) 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 .

If clinically indicated at treating physician judgement, patients could receive 1 mg of vincristine on the first day of prephase ; in this case vincristine administration in cycle 1 of immunochemotherapy should be skipped, in patients receiving R-miniCHOP; reduced to 1 mg, in patients receiving R-CHOP.

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 (Cholecalciferol) 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.

If clinically indicated at treating physician judgement, patients could receive 1 mg of vincristine on the first day of prephase (DAY -6); in this case vincristine administration in cycle 1 of immunochemotherapy should be: skipped, in patients receiving R-miniCHOP; reduced to 1 mg, in patients receiving R-CHOP.

Patients with 25(OH)VitD levels <30 ng/ml on d1 cycle 2 will receive and additional loading phase of Cholecalciferol 25,000 U/day for 7 days and then 25,000 U once weekly for the duration of immunochemotherapy.

Patients may continue with VitD supplementation after the end of the immunochemotherapy at a (reduced) standard dose of 25,000 U once a month for up to 2 years from end of immunochemotherapy.

Patients experimenting toxicity leading to a delay in treatment administration > 4 weeks will discontinue study treatment and will be addressed to a salvage treatment: these patients will be followed-up for survival until the end of the study.

Consolidation radiotherapy:

Being tested
Vitamin D3 (Cholecalciferol), RCHOP o R-miniCHOP at standard doses
Keywords
Vitamin D, prednisone +/- Vitamin D supplementation, randomized, open label, phase III
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin D3 (Cholecalciferol)Drug

    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 dosesDrug

    Patients on both arms receive pre-treatment with prednisone oral before 6 cycles of 21 days each of immunochemotherapy with RCHOP

    • R-miniCHOP at standard doses
Study groups in NCT04442412
Study groupRoleWhat they receive
Arm B (Experimental):ExperimentalPatients 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.
Receives: Drug: Vitamin D3 (Cholecalciferol); Drug: RCHOP o R-miniCHOP at standard doses
Arm A (Standard arm)OtherPatients 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
Receives: Drug: RCHOP o R-miniCHOP at standard doses

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival

    Progression-Free Survival

    Measured: at the end of treatment - 54 months

Secondary outcomes (8)

  1. Overall Survival

    Overall Survival

    Measured: at the end of treatment - 54 months

  2. Event Free Survival

    Event Free Survival (EFS)

    Measured: at the end of treatment - 54 months

  3. Response rate

    Response rate

    Measured: at the end of treatment - 54 months

  4. Early death rate

    Early death rate

    Measured: at the end of treatment - 54 months

  5. Rate of ECOG changes after prephase

    Rate of ECOG changes after prephase

    Measured: at the end of treatment - 54 months

  6. Rate of patients who maintain 25(OH)VitD levels

    Rate of patients who maintain 25(OH)VitD levels

    Measured: At the beginning of Cycle 2 (each cycle is 21 days)

  7. Rate of 25(OH)VitD correction (VitD supplementation arm)

    Rate of 25(OH)VitD correction (VitD supplementation arm)

    Measured: At the beginning of Cycle 2 (each cycle is 21 days)

  8. time-to-deterioration physical functioning and fatigue

    time-to-deterioration physical functioning and fatigue

    Measured: At the beginning of Cycle 2 (each cycle is 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2020
  2. Study start23 Mar 2021
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completion1 Sep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
430 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04442412
Sponsor's protocol ID
FIL_PREVID
Acronym
FIL_PREVID
Status last verified
Aug 2022
First submitted
26 May 2020
Last updated
26 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: This is an open-label, multicenter, randomized phase III trial. The study plans to randomize patients with a 1:1 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 (CGA) result, but treatment at reduced doses with R-miniCHOP is highly recommended option for UNFIT and FRAIL patients.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vitamin D3 (Cholecalciferol) and RCHOP o R-miniCHOP at standard doses in people with Diffuse Large B-Cell Lymphoma and Elderly Patients, run by Fondazione Italiana Linfomi - ETS at 49 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lorenza Randi, Dott.ssa (0000000000, lrandi@filinf.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (time frame: at the end of treatment - 54 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04442412.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.

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