OncoMatch/Clinical Trials/NCT04442412
Prephase Treatment With Prednisone +/- Vitamin D Supplementation Followed by Immunochemotherapy
Is NCT04442412 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Vitamin D3 (Cholecalciferol) and RCHOP o R-miniCHOP at standard doses for diffuse large b-cell lymphoma.
Treatment: Vitamin D3 (Cholecalciferol) · RCHOP o R-miniCHOP at standard doses — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Excluded: MYC rearrangement
HGBL, with rearrangement of MYC, BCL2 and/or BCL6 (double-hit)
Excluded: BCL2 rearrangement
HGBL, with rearrangement of MYC, BCL2 and/or BCL6 (double-hit)
Excluded: BCL6 rearrangement
HGBL, with rearrangement of MYC, BCL2 and/or BCL6 (double-hit)
Disease stage
Required: Stage I, II, III, IV
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Cannot have received: any anti-cancer therapy
Lab requirements
Blood counts
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
Kidney function
creatinine ≤ 2 mg/dl, unless secondary to lymphoma
Liver function
bilirubin ≤ 2 mg/dl unless secondary to lymphoma
Cardiac function
lvef > 50% at bidimensionally echocardiogram
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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