The goal of this clinical trial is to evaluate whether a high-intensity loading dose of ergocalciferol (vitamin D2) can normalize blood vitamin D levels more rapidly and safely than standard weekly dosing in patients with newly diagnosed aggressive non-Hodgkin lymphoma. The study will also assess the safety of both dosing strategies.
The main questions it aims to answer are:
* Does a high-intensity loading dose of ergocalciferol lead to faster normalization of serum 25-hydroxyvitamin D levels compared with standard weekly dosing? * Are there differences in safety and adverse events between the two dosing strategies?
Researchers will compare a high-intensity loading dose regimen of ergocalciferol with a standard weekly dosing regimen to determine differences in vitamin D normalization and safety outcomes.
Participants will:
* Be randomly assigned to receive either a high-intensity loading dose or a standard weekly dose of ergocalciferol (vitamin D2) * Receive standard first-line immunochemotherapy for aggressive non-Hodgkin lymphoma * Have blood tests to monitor vitamin D levels, calcium, phosphate, and safety parameters at scheduled visits * Be followed for treatment response, survival outcomes, and adverse events during and after therapy
Age ≥ 20 years.
Newly diagnosed aggressive non-Hodgkin lymphoma, confirmed by histopathological examination according to the WHO Classification of Haematolymphoid Tumours, 5th edition, with an indication for standard first-line chemoimmunotherapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
Serum 25-hydroxyvitamin D level < 30 ng/mL within 14 days prior to randomization.
Mild hypercalcemia (corrected Ca > 10.4 mg/dL)
Hyperphosphatemia (PO4 > 4.5 mg/dL)
History of urolithiasis associated with hypercalciuria or a diagnosis of primary hyperparathyroidism.
Chronic kidney disease stage 4 or higher (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m²).
Parallel
High-Dose Loading Ergocalciferol
DrugDose and Schedule: * Loading phase: Ergocalciferol 20,000 IU orally once daily (1 capsule per dose), administered 1-2 hours before breakfast, for 7 consecutive days. * Intensified phase: Following the loading phase, ergocalciferol 20,000 IU orally three times per week (Monday, Wednesday, and Friday) for a total treatment duration of 6 weeks from the first dose. * Maintenance phase: After completion of the initial 6-week treatment period, ergocalciferol 20,000 IU orally once weekly (Monday) until completion of lymphoma treatment. * Maximum duration of vitamin D₂ administration: Up to 18 weeks from the first dose of ergocalciferol. Thereafter, vitamin D dosing may be adjusted at the discretion of the treating physician.
Standard Weekly Ergocalciferol
DrugDose and Schedule: * Standard phase: Ergocalciferol 20,000 IU orally three times per week (Monday, Wednesday, and Friday), administered as 1 capsule per dose, 1-2 hours before breakfast, for a total duration of 6 weeks from the first dose. * Maintenance phase: After completion of the 6-week standard dosing period, ergocalciferol 20,000 IU orally once weekly (Monday) until completion of lymphoma treatment. * Maximum duration of vitamin D₂ administration: Up to 18 weeks from the first dose of ergocalciferol. Thereafter, vitamin D dosing may be adjusted at the discretion of the treating physician.
Proportion of Participants Achieving Vitamin D Normalization by Day 21
Vitamin D normalization is defined as a serum 25-hydroxyvitamin D level ≥ 30 ng/mL. This outcome is assessed as a binary outcome (yes/no).
Event-Free Survival (EFS)
Event-free survival is defined as the time from randomization to the first occurrence of disease progression, relapse after response, initiation of new lymphoma therapy, or death from any cause.
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from randomization to the first documented disease progression according to the Lugano 2014 criteria or death from any cause, whichever occurs first.
Overall Survival (OS)
Overall survival is defined as the time from randomization to death from any cause.
Best Overall Response (BOR)
Best overall response is defined as the best response achieved after completion of first-line immunochemotherapy, including complete response (CR) or partial response (PR), as assessed by PET-CT or CT scan according to the Lugano 2014 criteria.
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