Phase 3
Completed N=211
A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma
Source: ClinicalTrials.gov NCT03078855 ↗Enrolled (actual)
211
Serious AEs
12.1%
Results posted
Sep 2024
Primary outcomePrimary: Event Free Survival — 47.7; 49.5 Percentage of Participants — p=0.26
◆ Published Evidence
Emerging
9citations · ~5 / year
Vitamin D in patients with low tumor-burden indolent non-Hodgkin lymphoma treated with rituximab therapy (ILyAD): a randomized, phase 3 clinical trial.
Summary
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.
Linked Publications
-
Vitamin D in patients with low tumor-burden indolent non-Hodgkin lymphoma treated with rituximab therapy (ILyAD): a randomized, phase 3 clinical trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event Free Survival |
47.7; 49.5 | 0.26 |
| SECONDARY All-Cause Mortality |
4; 3 | — |
| SECONDARY Number of Participants With Treatment Response at 13 Weeks |
113; 59 | — |
Eligibility Criteria
Inclusion Criteria
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
- 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 1.5X above upper limit of normal
- Women who are known to be pregnant or who plan to become pregnant while on rituximab treatment
Data sourced from ClinicalTrials.gov (NCT03078855) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.