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Completed

NCT Number: NCT03078855

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

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.

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Key information

Conditions

Follicular Lymphoma Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Marginal Zone Lymphoma Mucosal-Associated Lymphoid Tissue Lymphoma Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Small Lymphocytic Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Miami, Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Dietary Supplement

vitamin D3 2,000 IU daily

Other names: Cholecalciferol

Rituximab

Biological

Administered weekly x 4

Other names: Rituxan

Placebo

Other

methylcellulose

Primary outcomes

  1. Event Free Survival

    Time frame: 3 years

    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.

Secondary outcomes

  1. All-Cause Mortality

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

  2. Number of Participants With Treatment Response at 13 Weeks

    Time frame: 13 Weeks from the start of treatment

    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.

Sponsors and collaborators

Lead sponsor

Jonathan Friedberg

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

ILyAD (Indolent Lymphoma And Vitamin D) A Phase III Double Blind, Randomized Trial to Evaluate the Effect of Vitamin D on Progression-free Survival in Patients With Low Tumor-burden Indolent Non-Hodgkin Lymphoma Treated With Rituximab

Acronym: ILyAD

Important dates

Study start
2017
Primary completion
2023
Study completion
2024
First posted
Mar 13, 2017
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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