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Clinical Trials in Italy / NCT04442412
Recruiting Phase 3

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

NCT04442412 · tracked via the Priya Life Science Italy tracker
Phase
Phase 3
Started
2021-03-23
Last updated
2022-08-26

Condition(s) studied

Diffuse Large B-Cell LymphomaElderly Patients

Investigational drug(s) / intervention(s)

Vitamin D3 (Cholecalciferol) →RCHOP o R-miniCHOP at standard doses

Vitamin D3 (Cholecalciferol): 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 doses: Patients on both arms receive pre-treatment with prednisone oral before 6 cycles of 21 days each of immunochemotherapy with RCHOP o R-miniCHOP at standard doses

Study 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

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion criteria 1. 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. 2. Age ≥ 65 years 3. Comprehensive Geriatric Assessment performed at baseline, before start of any treatment. 4. Eastern Cooperative Oncology Group performance status (PS) ≤3 5. Eligibility for anthracycline containing regimen (R-CHOP or R-miniCHOP) 6. No previous treatment for DLBCL or Follicular grade IIIb lymphoma 7. Ann Arbor stage I-IV 8. 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 9. Serum basic levels of Vitamin D \[25 (OH) VitD\] ≤ 40 ng / ml; 10. 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 11. Adequate renal function defined as follows: \- Creatinine ≤ 2 mg/dL, unless secondary to lymphoma 12. Adequate hepatic function defined as follows: \- Bilirubin ≤ 2 mg/dL unless secondary to lymphoma 13. LVEF \> 50% at bidimensionally echocardiogram 14. Life expectancy ≥ 6 months 15. 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 16. Subject must be able to adhere to the study visit schedule and other protocol requirements 17. 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. Exclusion criteria 1. 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) 2. Use of VitD supplementation as standard of care at dose higher than 10,000 U/week 3. Suspect or clinical evidence of CNS involvement by lymphoma 4. Contraindication to the use of rituximab 5. Contraindication to the use of VitD supplementation (Hypercalcemia/Hyperphosphatemia) 6. 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 7. 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 8. 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 9. 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.

Primary outcome measure(s)

Trial sites (49)

FacilityCityRegionStatus
SC Ematologia Spedali Civili Brescia BS Recruiting
UO Ematologia e CTMO di Piacenza Piacenza PC Recruiting
Ospedale Oncologico regionale CROB Rionero in Vulture Piacenza 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
Unità Funzionale di Ematologia AOU Careggi Florence Italy Recruiting
Frosinone - Presidio Ospedaliero F. Spaziani - UOC Ematologia Frosinone Italy Not Yet Recruiting
Matera - Ospedale Madonna delle Grazie - Ematologia Matera Italy Not Yet Recruiting
Meldola - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) - Ematologia Meldola Italy Recruiting
Mestre - Ospedale Dell Angelo - U.O. Ematologia Mestre Italy Not Yet Recruiting
SC Ematologia AO Niguarda Cà Granda Milan Italy Not Yet Recruiting
Monza - ASST MONZA Ospedale S. Gerardo - Ematologia Monza Italy Recruiting
Napoli - AOU Universitа degli Studi della Campania Luigi Vanvitelli - Oncologia Medica ed Ematologia Naples Italy Not Yet Recruiting
Università del Piemonte Orientale - Novara Novara Italy Not Yet Recruiting
Padova - I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1 Padova Italy Not Yet Recruiting
Pagani - Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia Pagani Italy Not Yet Recruiting
Palermo - A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia Palermo Italy Not Yet Recruiting
Palermo - AOU Policlinico Giaccone - Ematologia Palermo Italy Recruiting
UO Ematologia Università - Policlinico San Matteo Pavia Italy Recruiting
Pescara - P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi Pescara Italy Not Yet Recruiting
Potenza - AOR San Carlo Potenza Italy Not Yet Recruiting
UO Ematologia Ospedale Santa Maria delle Croci Ravenna Italy Recruiting
Reggio Emilia - AO Santa Maria Nuova Reggio Emilia Italy Recruiting
UO Ematologia - Ospedale degli Infermi Rimini Italy Not Yet Recruiting
Roma - IRCCS Spallanzani - Servizio di Ematologia in malattie infettive Roma Italy Not Yet Recruiting
Roma - Ospedale S. Camillo - Ematologia Roma Italy Not Yet Recruiting
Roma - Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare Roma Italy Recruiting
Università Cattolica S. Cuore, Ematologia Roma Italy Not Yet Recruiting
Università La Sapienza Ematologia Roma Italy Not Yet Recruiting
UOC Ematologia - A.O. Sant'Andrea Roma Italy Not Yet Recruiting
Salerno - Ematologia e Trapianti A.O. San Giovanni di Dio e Ruggi D Aragona - U.O. Ematologia Salerno Italy Recruiting
San Giovanni Rotondo - Casa Sollievo della Sofferenza - U.O. Ematologia San Giovanni Rotondo Italy Not Yet Recruiting
Sassari - AOU di Sassari - Ematologia Sassari Italy Not Yet Recruiting

+ 9 more sites — see the full list on the official registry below.

More Fondazione Italiana Linfomi - ETS trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04442412 on ClinicalTrials.gov ↗ ← All trials in Italy