OncoMatch/Clinical Trials/NCT04442412
Prephase Treatment With Prednisone +/- Vitamin D Supplementation Followed by Immunochemotherapy
Is NCT04442412 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT04442412 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Are patients with MYC alterations eligible?
No. MYC rearrangement is an exclusion criterion.
Are patients with BCL2 alterations eligible?
No. BCL2 rearrangement is an exclusion criterion.
What disease stage is eligible?
Stage I or II or III or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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