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NCT03078855CompletedPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 4 Sept 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
211 (actual)
First submitted
8 Mar 2017
Start date
7 Sept 2017
Primary completion date
21 Jul 2023
Lead sponsor
Jonathan Friedberg
NCT number
NCT03078855

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 211
  • From 7 Sept 2017 to the primary completion date, 21 Jul 2023
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • 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

Other

  • The following criteria will prevent inclusion of an inappropriate subject into the trial:
  • Osteoporosis requiring prescription treatment
  • Known symptomatic primary hyperparathyroidism
  • Women who are known to be pregnant or who plan to become pregnant while on rituximab treatment

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Emory University/Winship Cancer Institute
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
The University of Texas MD Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
University of Iowa
Coordinator of this site? Confirm its status
Iowa CityUnited StatesUnknown status
University of Miami
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status
Weill Cornell Medical College
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
James P. Wilmot Cancer Institute at University of Rochester Medical Center
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
Washington University
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.