Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT04442412

PHASE3

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

Sponsor: Fondazione Italiana Linfomi - ETS

View on ClinicalTrials.gov

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.

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.

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

430

Start Date

2021-03-23

Completion Date

2030-09-01

Last Updated

2022-08-26

Healthy Volunteers

Conditions

Diffuse Large B-Cell Lymphoma Elderly Patients

Interventions

DRUG

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.

DRUG

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

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.

Locations (49)

SC Ematologia Spedali Civili

Brescia, BS, Italy

UO Ematologia e CTMO di Piacenza

Piacenza, PC, Italy

Ospedale Oncologico regionale CROB

Rionero in Vulture, Piacenza, Italy

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

Alessandria, Italy

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

Ancona, Italy

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

Ascoli Piceno, Italy

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

Aviano, Italy

Barletta - Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia

Barletta, Italy

Bergamo - Cliniche Humanitas Gavazzeni - Oncologia - Cliniche Humanitas Gavazzeni

Bergamo, Italy

Biella - Ospedale Degli Infermi - S.C. Oncologia

Biella, Italy

Campobasso - Universitа Cattolica del Sacro Cuore - Ematologia

Campobasso, Italy

Castelfranco Veneto - Ospedale di Castelfranco Veneto - Ematologia

Castelfranco Veneto, Italy

Unità Funzionale di Ematologia AOU Careggi

Florence, Italy

Frosinone - Presidio Ospedaliero F. Spaziani - UOC Ematologia

Frosinone, Italy

Matera - Ospedale Madonna delle Grazie - Ematologia

Matera, Italy

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

Meldola, Italy

Mestre - Ospedale Dell Angelo - U.O. Ematologia

Mestre, Italy

SC Ematologia AO Niguarda Cà Granda

Milan, Italy

Monza - ASST MONZA Ospedale S. Gerardo - Ematologia

Monza, Italy

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

Naples, Italy

Università del Piemonte Orientale - Novara

Novara, Italy

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

Padova, Italy

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

Pagani, Italy

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

Palermo, Italy

Palermo - AOU Policlinico Giaccone - Ematologia

Palermo, Italy

UO Ematologia Università - Policlinico San Matteo

Pavia, Italy

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

Pescara, Italy

Potenza - AOR San Carlo

Potenza, Italy

UO Ematologia Ospedale Santa Maria delle Croci

Ravenna, Italy

Reggio Emilia - AO Santa Maria Nuova

Reggio Emilia, Italy

UO Ematologia - Ospedale degli Infermi

Rimini, Italy

Roma - IRCCS Spallanzani - Servizio di Ematologia in malattie infettive

Roma, Italy

Roma - Ospedale S. Camillo - Ematologia

Roma, Italy

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

Roma, Italy

Università Cattolica S. Cuore, Ematologia

Roma, Italy

Università La Sapienza Ematologia

Roma, Italy

UOC Ematologia - A.O. Sant'Andrea

Roma, Italy

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

Salerno, Italy

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

San Giovanni Rotondo, Italy

Sassari - AOU di Sassari - Ematologia

Sassari, Italy

UOC Medicina Interna MO DH Oncologico

Sassuolo, Italy

UOC Ematologia, AOU Senese

Siena, Italy

Univ. Perugia Sede Terni - Oncoematologia

Terni, Italy

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

Torino, Italy

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

Torino, Italy

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

Torino, Italy

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

Trieste, Italy

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

Udine, Italy

ULSS 8 Berica - Ospedale S. Bortolo - Ematologia

Vicenza, Italy

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (49)