NCT03078855CompletedPhase 3
A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma
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
Source: ClinicalTrials.gov · Last updated 4 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 211 (actual)
- First submitted
- 8 Mar 2017
- Start date
- 7 Sept 2017
- Primary completion date
- 21 Jul 2023
- Lead sponsor
- Jonathan Friedberg
- Diseases
- Follicular lymphoma
- NCT number
- NCT03078855
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 211
- From 7 Sept 2017 to the primary completion date, 21 Jul 2023
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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
Other
- The following criteria will prevent inclusion of an inappropriate subject into the trial:
- Osteoporosis requiring prescription treatment
- Known symptomatic primary hyperparathyroidism
- Women who are known to be pregnant or who plan to become pregnant while on rituximab treatment
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University/Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of Iowa Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Weill Cornell Medical College Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| James P. Wilmot Cancer Institute at University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
Related publications
- Vitamin D in patients with low tumor-burden indolent non-Hodgkin lymphoma treated with rituximab therapy (ILyAD): a randomized, phase 3 clinical trial.EClinicalMedicine · 2024 · PMID 39677358
This page is information, not medical advice. Discuss any trial with your doctor.