Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07366450
Eligibility Criteria:
Inclusion Criteria:
* 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.
* Adequate organ function to receive full-dose standard chemotherapy.
* Ability to provide written informed consent.
Exclusion Criteria:
* 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).
* Inability to take oral medication, active gastrointestinal bleeding, or malabsorption syndrome.
* Pregnancy or breastfeeding.
* Prior systemic therapy for lymphoma.
* Ongoing tumor lysis syndrome requiring urgent treatment.
* Prior use of vitamin D supplements (ergocalciferol or cholecalciferol).
Withdrawal Criteria:
* Development of mild hypercalcemia.
* Development of mild hypophosphatemia.
* Development of hypervitaminosis D.
* Occurrence of severe adverse events (AEs) or side effects for which the investigator considers discontinuation of the study drug necessary for patient safety.
* Investigator's judgment that continued participation may pose a safety risk, such as the occurrence of serious infection, febrile neutropenia, or organ failure.
* Non-adherence to study medication, defined as cumulative vitamin D₂ intake of less than 80% of the expected cumulative dose at the time of serum vitamin D assessment.
* Participant withdrawal of consent to continue participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT07366450
Study Brief:
Protocol Section:
NCT07366450