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

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
Follicular Lymphoma Small Lymphocytic Lymphoma Marginal Zone Lymphoma Mucosal-Associated Lymphoid Tissue Lymphoma	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

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

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

Time from randomization to death [Year three]
Mean time to death
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:

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