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

Recruiting now · Phase 3

Conditions studied: Diffuse Large B-Cell Lymphoma, Elderly Patients

In brief

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.

Key facts

Study ID

NCT04442412

Run by

Fondazione Italiana Linfomi - ETS

People needed

430

Starts

2021-03-23

Expected to finish

2030-09-01

Last updated by the study team

2022-08-26

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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.

You may not qualify if…

• 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
• 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.

Where it is running

• ULSS 8 Berica - Ospedale S. Bortolo - Ematologia — Vicenza, Italy (enrolling)
• UO Ematologia e CTMO di Piacenza — Piacenza, PC, Italy (enrolling)
• A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia — Alessandria, Italy (enrolling)
• A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona — Ancona, Italy (enrolling)
• Aviano - Centro Riferimento Oncologico - S.O.C. Oncologia Medica A — Aviano, Italy (enrolling)
• Unità Funzionale di Ematologia AOU Careggi — Florence, Italy (enrolling)
• Meldola - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) - Ematologia — Meldola, Italy (enrolling)
• Monza - ASST MONZA Ospedale S. Gerardo - Ematologia — Monza, Italy (enrolling)
• Palermo - AOU Policlinico Giaccone - Ematologia — Palermo, Italy (enrolling)
• UO Ematologia Università - Policlinico San Matteo — Pavia, Italy (enrolling)
• UO Ematologia Ospedale Santa Maria delle Croci — Ravenna, Italy (enrolling)
• Reggio Emilia - AO Santa Maria Nuova — Reggio Emilia, Italy (enrolling)
• Roma - Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare — Roma, Italy (enrolling)
• Salerno - Ematologia e Trapianti A.O. San Giovanni di Dio e Ruggi D Aragona - U.O. Ematologia — Salerno, Italy (enrolling)
• UOC Medicina Interna MO DH Oncologico — Sassuolo, Italy (enrolling)
• UOC Ematologia, AOU Senese — Siena, Italy (enrolling)
• Univ. Perugia Sede Terni - Oncoematologia — Terni, Italy (enrolling)
• AOU Citta della Salute e della Scienza di Torino - Ematologia Universitaria — Torino, Italy (enrolling)
• SC. Ematologia A.O. Città della Salute e della Scienza — Torino, Italy (enrolling)
• Trieste - Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia — Trieste, Italy (enrolling)
• SC Ematologia Spedali Civili — Brescia, BS, Italy (enrolling)
• 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
• UOC Ematologia - A.O. Sant'Andrea — Roma, Italy

Full record on ClinicalTrials.gov

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