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Monoclonal Antibodies

Vitamin D for Lymphoma (ILyAD Trial)

Phase 3
Waitlist Available
Led By Jonathan W. Friedberg, MD
Research Sponsored by Jonathan Friedberg
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 or over
Biopsy proven indolent lymphoma including Grade 1, 2, or 3a follicular lymphoma, Small lymphocytic lymphoma, Marginal zone lymphoma, Mucosal-associated lymphoid tissue
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year three
Awards & highlights

ILyAD Trial Summary

This trial will test whether giving cancer patients supplements of vitamin D will improve their outcomes.

Who is the study for?
This trial is for adults with certain types of indolent Non-Hodgkin's Lymphoma, including follicular lymphoma and marginal zone lymphoma. Participants must have measurable disease, no prior systemic therapy for lymphoma (though radiation is okay), and meet specific health criteria. Pregnant women or those planning pregnancy during the trial are excluded.Check my eligibility
What is being tested?
The study tests if Vitamin D supplementation can improve progression-free survival in patients undergoing treatment for indolent Non-Hodgkin's Lymphoma compared to a placebo. All participants will also receive Rituximab as part of their treatment regimen.See study design
What are the potential side effects?
Possible side effects include reactions related to Vitamin D such as high calcium levels, which could lead to kidney stones or bone issues. Rituximab may cause infusion reactions, infections, low blood cell counts, and heart problems.

ILyAD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have a slow-growing type of lymphoma.
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My cancer is at stage II, III, or IV according to the Ann Arbor classification.
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My follicular lymphoma is classified as low tumor burden.
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I haven't had any drug treatments for lymphoma, but I may have had radiation.

ILyAD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year three
This trial's timeline: 3 weeks for screening, Varies for treatment, and year three for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to progression or death
Secondary outcome measures
Response to rituximab defined as reduction of lymphoma burden by at least 50%
Time from randomization to death

Side effects data

From 2016 Phase 4 trial • 1366 Patients • NCT01709110
12%
Back pain
7%
Arthralgia
3%
Fall
1%
Hip fracture
1%
Humerus fracture
1%
Lumbar vertebral fracture
1%
Osteoarthritis
1%
Femur fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Risedronate
Teriparatide

ILyAD Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Vitamin D plus rituximabExperimental Treatment2 Interventions
Group II: Placebo plus rituximabPlacebo Group2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin D
2013
Completed Phase 4
~3470
Rituximab
1999
Completed Phase 4
~1880

Find a Location

Who is running the clinical trial?

Jonathan FriedbergLead Sponsor
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,016 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,153 Total Patients Enrolled
~28 spots leftby Jun 2025
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