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

Jonathan Friedberg211 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

211

Conditions

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

Interventions

Vitamin DDIETARY_SUPPLEMENT

vitamin D3 2,000 IU daily

RituximabBIOLOGICAL

Administered weekly x 4

PlaceboOTHER

methylcellulose

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 * \< 3 distinct masses of greater than 3 cm * No B symptoms * No splenomegaly \> 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 \< 100,000/µl, hemoglobin \< 10 g/dl, or absolute neutrophil count \< 1500/µl) Exclusion Criteria: The following criteria will prevent inclusion of an inappropriate subject into the trial: * Osteoporosis requiring prescription treatment * Known symptomatic primary hyperparathyroidism * Hypercalcemia defined as above the institutional normal range (corrected for albumin when albumin levels are below normal) * History of calcium-related kidney stones * Creatinine \> 1.5X above upper limit of normal * Women who are known to be pregnant or who plan to become pregnant while on rituximab treatment

Locations (7)

University of Miami

Miami, Florida, United States

Emory University, Winship Cancer Institute

Atlanta, Georgia, United States

University of Iowa

Iowa City, Iowa, United States

Washington University

St Louis, Missouri, United States

Outcomes

Primary Outcomes

Event Free Survival

Event free survival (EFS) was defined as the time from randomization to lack of response at week 13, initiation of a new treatment, disease progression defined by Lugano criteria, or death, right-censored by time of last follow-up. Per Lugano criteria, progression is defined as a new FDG-avid lesion or an increase in intensity from baseline, an increase by \>= 50% in lesion diameters, a new lymph node \> 1.5 cm in any axis or a new extranodal site \> 1.0 cm.

Time frame: 3 years

Secondary Outcomes

All-Cause Mortality

Number of participants who died from any cause between day 1 of treatment and the time of last follow-up.

Time frame: Participants were followed for survival beginning on day 1 of treatment until study closure with a maximum follow-up of 64 months.

Number of Participants With Treatment Response at 13 Weeks

Participants had imaging performed at week 13 to assess response to treatment. A response was defined as partial (PR) or complete response (CR) according to Lugano criteria. Per Lugano criteria for target lesions: PR includes reduced metabolic uptake or a ≥ 50% decrease in the sum of the products of the diameters compared to baseline. CR includes metabolic score of 1, 2 or 3 (out of 5) with or without residual mass or regression of target lesions to ≤ 1.5 cm in the longest dimension.

Time frame: 13 Weeks from the start of treatment

Data from ClinicalTrials.gov

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