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Trial record 1 of 2 for:    ilyad
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A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma (ILyAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03078855
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : February 17, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonathan Friedberg, University of Rochester

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
Follicular Lymphoma Small Lymphocytic Lymphoma Marginal Zone Lymphoma Mucosal-Associated Lymphoid Tissue Lymphoma Dietary Supplement: Vitamin D Biological: Rituximab Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 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 : September 7, 2017
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023


Arm Intervention/treatment
Experimental: Vitamin D plus rituximab Dietary Supplement: Vitamin D
vitamin D3 2,000 IU daily
Other Name: Cholecalciferol

Biological: Rituximab
Administered weekly x 4
Other Name: Rituxan

Placebo Comparator: Placebo plus rituximab Biological: Rituximab
Administered weekly x 4
Other Name: Rituxan

Other: Placebo
methylcellulose




Primary Outcome Measures :
  1. Time to progression or death [ Time Frame: 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 [ Time Frame: Year three ]
    Mean time to death

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



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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03078855


Contacts
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Contact: Michael Brady, PhD 585-276-3203 michael_brady@urmc.rochester.edu

Locations
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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Karin Suarez       karin.suarez@med.miami.edu   
Principal Investigator: Izidore Lossos, MD         
United States, Georgia
Emory University, Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Vanessa Smith    404-778-2419    vanessa.smith@emory.edu   
Principal Investigator: Christopher Flowers, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Pamela Zehr       pamela-zehr@uiowa.edu   
Principal Investigator: Brian Link, MD         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63130
Contact: Katrina Peterson       kncruz@wustl.edu   
Principal Investigator: Brad Kahl, MD         
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Amelyn Rodriguez, RN       amr2017@med.cornell.edu   
Principal Investigator: John P. Leonard, MD         
James P. Wilmot Cancer Institute at University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Krista French    585-276-5812    Krista_French@URMC.Rochester.edu   
Principal Investigator: Jonathan W. Friedberg, MD         
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Linda Claret, RN    713-792-1044    lcclaret@mdanderson.org   
Principal Investigator: Loretta Nastoupil, MD         
Sponsors and Collaborators
Jonathan Friedberg
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jonathan W. Friedberg, MD James P. Wilmot Cancer Institute at University of Rochester
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Responsible Party: Jonathan Friedberg, Director, Wilmot Cancer Institute, University of Rochester
ClinicalTrials.gov Identifier: NCT03078855    
Other Study ID Numbers: 66593
R01CA214890 ( U.S. NIH Grant/Contract )
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell, Marginal Zone
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia
Vitamin D
Cholecalciferol
Rituximab
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Antirheumatic Agents
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents