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

Primary Purpose

Follicular Lymphoma, Small Lymphocytic Lymphoma, Marginal Zone Lymphoma

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Vitamin D
Rituximab
Placebo
Sponsored by
Jonathan Friedberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Follicular Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Miami
  • Emory University, Winship Cancer Institute
  • University of Iowa
  • Washington University
  • Weill Cornell Medical College
  • James P. Wilmot Cancer Institute at University of Rochester Medical Center
  • The University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D plus rituximab

Placebo plus rituximab

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time from randomization to death
Mean time to death
Response to rituximab defined as reduction of lymphoma burden by at least 50%
Response is defined as reduction of lymphoma burden by at least 50%

Full Information

First Posted
March 8, 2017
Last Updated
September 6, 2023
Sponsor
Jonathan Friedberg
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03078855
Brief Title
A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma
Acronym
ILyAD
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 7, 2017 (Actual)
Primary Completion Date
July 21, 2023 (Actual)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jonathan Friedberg
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Lymphoma, Small Lymphocytic Lymphoma, Marginal Zone Lymphoma, Mucosal-Associated Lymphoid Tissue Lymphoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D plus rituximab
Arm Type
Experimental
Arm Title
Placebo plus rituximab
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
Cholecalciferol
Intervention Description
vitamin D3 2,000 IU daily
Intervention Type
Biological
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan
Intervention Description
Administered weekly x 4
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
methylcellulose
Primary Outcome Measure Information:
Title
Time to progression or death
Description
Mean time to death or progression defined as increase in lymphoma burden by at least 50%
Time Frame
Year three
Secondary Outcome Measure Information:
Title
Time from randomization to death
Description
Mean time to death
Time Frame
Year three
Title
Response to rituximab defined as reduction of lymphoma burden by at least 50%
Description
Response is defined as reduction of lymphoma burden by at least 50%
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 < 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan W. Friedberg, MD
Organizational Affiliation
James P. Wilmot Cancer Institute at University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory University, Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
James P. Wilmot Cancer Institute at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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