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

Sponsor
Jonathan Friedberg (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03078855
Collaborator
National Institutes of Health (NIH) (NIH), National Cancer Institute (NCI) (NIH)
211
7
2
71.8
30.1
0.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Vitamin D
  • Biological: Rituximab
  • Other: Placebo
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
211 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
ILyAD (Indolent Lymphoma And Vitamin D) A Phase III Double Blind, Randomized Trial to Evaluate the Supplemental Effect of Vitamin D on Progression-free Survival in Patients With Low Tumor-burden Indolent Non-Hodgkin Lymphoma Treated With Rituximab
Actual Study Start Date :
Sep 7, 2017
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vitamin D plus rituximab

Dietary Supplement: Vitamin D
vitamin D3 2,000 IU daily
Other Names:
  • Cholecalciferol
  • Biological: Rituximab
    Administered weekly x 4
    Other Names:
  • Rituxan
  • Placebo Comparator: Placebo plus rituximab

    Biological: Rituximab
    Administered weekly x 4
    Other Names:
  • Rituxan
  • Other: Placebo
    methylcellulose

    Outcome Measures

    Primary Outcome Measures

    1. Time to progression or death [Year three]

      Mean time to death or progression defined as increase in lymphoma burden by at least 50%

    Secondary Outcome Measures

    1. Time from randomization to death [Year three]

      Mean time to death

    2. Response to rituximab defined as reduction of lymphoma burden by at least 50% [13 weeks]

      Response is defined as reduction of lymphoma burden by at least 50%

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Miami Miami Florida United States 33136
    2 Emory University, Winship Cancer Institute Atlanta Georgia United States 30322
    3 University of Iowa Iowa City Iowa United States 52242
    4 Washington University Saint Louis Missouri United States 63130
    5 Weill Cornell Medical College New York New York United States 10021
    6 James P. Wilmot Cancer Institute at University of Rochester Medical Center Rochester New York United States 14642
    7 The University of Texas MD Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Jonathan W. Friedberg, MD, James P. Wilmot Cancer Institute at University of Rochester

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jonathan Friedberg, Director, Wilmot Cancer Institute, University of Rochester
    ClinicalTrials.gov Identifier:
    NCT03078855
    Other Study ID Numbers:
    • 66593
    • R01CA214890
    First Posted:
    Mar 13, 2017
    Last Update Posted:
    Mar 8, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 8, 2022