ILyAD (Indolent Lymphoma And Vitamin D) A Phase III Double Blind, Randomized Trial to Evaluate the Effect of Vitamin D on Progression-free Survival in Patients With Low Tumor-burden Indolent Non-Hodgkin Lymphoma Treated With Rituximab
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 211
- 试验地点
- 13
- 主要终点
- Event Free Survival
研究概览
简要总结
Despite strong evidence suggesting that vitamin D deficiency is associated with undesirable outcomes in patients with numerous cancers, there has never been a thorough study of vitamin D treatment in subjects undergoing treatment for cancer. The purpose of this study is to evaluate whether modification of vitamin D levels in the blood, through supplementation, can improve outcomes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Each of the following criteria must be met in order for a patient to be considered eligible for registration:
- •Biopsy proven (with hematopathology review at one of the participating sites to confirm correct histology in accordance with World Health Organization) indolent lymphoma to include the following diagnoses:
- •Grade 1, 2, or 3a follicular lymphoma
- •Small lymphocytic lymphoma (CLL excluded)
- •Marginal zone lymphoma (nodal or splenic)
- •Mucosal-associated lymphoid tissue
- •Measurable disease defined by Lugano criteria
- •No prior anti-lymphoma systemic therapy; prior radiation therapy allowed
- •Age 18 or over
- •Ann Arbor stages II, III or IV
- •Patients with follicular lymphoma must have PET FDG-avid lymphoma and fulfill Low tumor burden by Groupe D'Etude des Lymphomes Folliculaires (GELF) criteria:
- •No mass > 7 cm
- •< 3 distinct masses of greater than 3 cm
- •No B symptoms
- •No splenomegaly > 16 cm by computed tomography (CT) scan
- •No risk of vital organ compression
- •No leukemic phase > 5000/µl circulating lymphocytes (except for in patients with splenic marginal zone diagnosis)
- •No cytopenias (platelets < 100,000/µl, hemoglobin < 10 g/dl, or absolute neutrophil count < 1500/µl)
排除标准
- •The following criteria will prevent inclusion of an inappropriate subject into the trial:
- •Osteoporosis requiring prescription treatment
- •Known symptomatic primary hyperparathyroidism
- •Hypercalcemia defined as above the institutional normal range (corrected for albumin when albumin levels are below normal)
- •History of calcium-related kidney stones
- •Creatinine > 1.5X above upper limit of normal
- •Women who are known to be pregnant or who plan to become pregnant while on rituximab treatment
结局指标
主要结局
Event Free Survival
时间窗: 3 years
Event free survival (EFS) was defined as the time from randomization to lack of response at week 13, initiation of a new treatment, disease progression defined by Lugano criteria, or death, right-censored by time of last follow-up. Per Lugano criteria, progression is defined as a new FDG-avid lesion or an increase in intensity from baseline, an increase by \>= 50% in lesion diameters, a new lymph node \> 1.5 cm in any axis or a new extranodal site \> 1.0 cm.
次要结局
- All-Cause Mortality(Participants were followed for survival beginning on day 1 of treatment until study closure with a maximum follow-up of 64 months.)
- Number of Participants With Treatment Response at 13 Weeks(13 Weeks from the start of treatment)
研究者
Jonathan Friedberg
Director, Wilmot Cancer Institute
University of Rochester