# Vitamin D and Follicular Lymphoma

> **NIH NIH R01** · UNIVERSITY OF ROCHESTER · 2022 · $592,475

## Abstract

ABSTRACT
Indolent non-Hodgkin lymphomas are incurable diseases, and require intermittent and often
morbid and expensive therapy during their prolonged natural history. Lower intensity and
better-tolerated, cost-effective treatment strategies are needed for these patients. Low vitamin
D levels at diagnosis of indolent lymphomas are strongly associated with inferior outcomes to
treatment. Standard therapy for low tumor burden, indolent lymphoma includes a single agent
monoclonal antibody (rituximab). In this proposal, we will complete a double-blind, placebo-
controlled randomized trial evaluating if vitamin D supplementation with 2000IU oral tablets daily
for three years improves the progression-free survival of patients with indolent lymphoma
treated with single agent rituximab. Stratification factors for randomization will include histology
and FL-IPI prognostic score. The primary endpoint of the trial is progression-free survival over
three years; secondary endpoints include response at 13 weeks, and overall survival. Planned
subset analyses include follicular lymphoma histology and female sex. With 210 randomized
patients, we will have 80% power to detect a HR = 0.55 at a two sided alpha = 0.05 level of
significance. This clinical trial will be coordinated at the University of Rochester Wilmot Cancer
Institute, and six expert lymphoma centers from the Lymphoma Epidemiology of Outcomes
(LEO) Consortium will participate. We will leverage this LEO consortium for tumor banking and
prospective patient-reported outcomes of enrolled patients. We will also identify if baseline
and/or restaging serum vitamin D levels predict subgroups of patients for whom Vitamin D
supplementation is particularly effective or particularly ineffective. Finally, since there is
evidence to suggest that response to oral vitamin D supplementation may be dependent upon
specific genotypes of the Vitamin D receptor (VDR) and vitamin D binding protein (DPB), we will
utilize whole exome sequencing to determine whether vitamin D-related germline variations are
critical determinants of outcome in the context of vitamin D supplementation of patients with
indolent lymphoma. Our aims the defining threshold levels of vitamin D where supplementation
is most effective and the impact of germline polymorphisms on outcome will inform future trial
designs and contribute to mechanistic understanding. Demonstrating a benefit to vitamin D
supplementation in this randomized trial would rapidly change standard of care in the most
common presentation of indolent lymphoma, and provide a low-risk, well-tolerated, inexpensive
option delaying the time to morbid treatments.

## Key facts

- **NIH application ID:** 10219983
- **Project number:** 5R01CA214890-05
- **Recipient organization:** UNIVERSITY OF ROCHESTER
- **Principal Investigator:** JONATHAN W FRIEDBERG
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $592,475
- **Award type:** 5
- **Project period:** 2017-08-01 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10219983

## Citation

> US National Institutes of Health, RePORTER application 10219983, Vitamin D and Follicular Lymphoma (5R01CA214890-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10219983. Licensed CC0.

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