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.
• 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.