High-Dose vs Standard Ergocalciferol for Vitamin D Normalization in Aggressive Non-Hodgkin Lymphoma

Официальное название

Safety and Efficacy of High-Intensity Loading Dose Versus Standard Weekly Dosing of Ergocalciferol (Vitamin D2) for Vitamin D Normalization in Patients With Newly Diagnosed Aggressive Non-Hodgkin Lymphoma: A Randomized, Open-Label, Controlled Trial

Обзор

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

Вмешательства

• Препарат High-Dose Loading Ergocalciferol
  Dose 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) unti
• Препарат Standard Weekly Ergocalciferol
  Dose 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 erg

Первичные конечные точки

• Proportion of Participants Achieving Vitamin D Normalization by Day 21 [Срок оценки: Day 21 (± 3 days) after the first dose of study medication]

Вторичные конечные точки (7)

• Event-Free Survival (EFS) [Срок оценки: Up to 3 years]
• Progression-Free Survival (PFS) [Срок оценки: Up to 3 years]
• Overall Survival (OS) [Срок оценки: Up to 3 years]
• Best Overall Response (BOR) [Срок оценки: Through the completion of first-line immunochemotherapy, approximately 24 weeks]
• Change in Serum 25-Hydroxyvitamin D Level [Срок оценки: Day 21 (± 3 days), Day 42 (± 3 days), Day 63 (± 3 days), and Day 126 (± 3 days) (end of treatment)]
• Incidence of Grade ≥ 3 Infections [Срок оценки: From randomization through 30 days after the last dose of study treatment, approximately 22 weeks]
• Safety and Treatment-Related Toxicity [Срок оценки: From randomization through 30 days after the last dose of study treatment, approximately 22 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Таиланд · 1 центр

• Phramonkutklao Hospital — Bangkok

Идентификаторы

NCT: NCT07366450 · Hemato-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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