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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Proportion of Participants Achieving Vitamin D Normalization by Day 21
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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.
研究组 & 干预措施
High-Dose Loading Ergocalciferol
Participants receive a high-dose loading regimen of ergocalciferol (vitamin D₂) for rapid normalization of serum vitamin D levels, in combination with standard first-line chemoimmunotherapy for aggressive non-Hodgkin lymphoma.
干预措施: High-Dose Loading Ergocalciferol (Drug)
Standard Weekly Ergocalciferol
Participants receive standard weekly dosing of ergocalciferol (vitamin D₂) for vitamin D normalization, in combination with standard first-line chemoimmunotherapy for aggressive non-Hodgkin lymphoma.
干预措施: Standard Weekly Ergocalciferol (Drug)
结局指标
主要结局
Proportion of Participants Achieving Vitamin D Normalization by Day 21
时间窗: Day 21 (± 3 days) after the first dose of study medication
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).
次要结局
- Event-Free Survival (EFS)(Up to 3 years)
- Progression-Free Survival (PFS)(Up to 3 years)
- Overall Survival (OS)(Up to 3 years)
- Best Overall Response (BOR)(Through the completion of first-line immunochemotherapy, approximately 24 weeks)
- Change in Serum 25-Hydroxyvitamin D Level(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(From randomization through 30 days after the last dose of study treatment, approximately 22 weeks)
- Safety and Treatment-Related Toxicity(From randomization through 30 days after the last dose of study treatment, approximately 22 weeks)