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



Status:Recruiting
Conditions:Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:September 7, 2017
End Date:September 2023
Contact:Michael Brady, PhD
Email:michael_brady@urmc.rochester.edu
Phone:585-276-3203

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

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.


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
We found this trial at
7
sites
Rochester, New York 14642
Principal Investigator: Jonathan W. Friedberg, MD
Phone: 585-276-5812
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Brian Link, MD
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Izidore Lossos, MD
University of Miami A private research university with more than 15,000 students from around the...
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Atlanta, Georgia 30322
Principal Investigator: Christopher Flowers, MD
Phone: 404-778-2419
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Loretta Nastoupil, MD
Phone: 713-792-1044
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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New York, New York 10021
Principal Investigator: John P. Leonard, MD
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Saint Louis, Missouri 63110
Principal Investigator: Brad Kahl, MD
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Saint Louis, MO
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