Phase 3 N=211 Randomized Quadruple-blind Supportive Care

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

Follicular Lymphoma · Small Lymphocytic Lymphoma · Marginal Zone Lymphoma · Mucosal-Associated Lymphoid Tissue Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT03078855 ↗

Enrolled (actual)

211

Serious AEs

12.1%

Results posted

Sep 2024

Primary outcome: Primary: Event Free Survival — 47.7; 49.5 Percentage of Participants — p=0.26

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Vitamin D (Dietary_supplement); Rituximab (Biological); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Jonathan Friedberg
Primary completion: Jul 2023

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	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03078855). 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.