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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ year three

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

Arthralgia

Fall

Hip fracture

Humerus fracture

Lumbar vertebral fracture

Osteoarthritis

Femur fracture

100%

80%

60%

40%

20%

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jonathan FriedbergLead Sponsor

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,377 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,942 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what purpose is Vitamin D often recommended?

"dlbcl, b-cell lymphomas, and polyangium can be effectively managed with Vitamin d."

Answered by AI

Are investigators currently looking for new test subjects?

"Presently, this particular trial is not recruiting any more patients. It was initially posted on September 7th, 2017 and was most recently updated on March 6th, 2022. There are 1931 trials actively recruiting patients with lymphoma and 421 trials actively recruiting patients for Vitamin d studies."

Answered by AI

approximately how many people are involved in this experiment?

"Currently, this clinical trial is not enrolling patients. The study was originally posted on September 7th, 2017 and was last edited on March 6th, 2022. However, if you are searching for other studies, there are presently 1931 studies actively enrolling participants with lymphoma, follicular and 421 studies for Vitamin d actively looking for patients."

Answered by AI

What are the most similar past studies to this one in terms of involving Vitamin D?

"The year 1993 saw the first study of Vitamin d at the National Institutes of Health Clinical Center. Since then, there have been 19,172 completed clinical trials on the topic. As of now, there are 421 active trials, a considerable number of which are based in Houston, Texas."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma

Jonathan Friedberg 2017. "A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03078855.

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