Clinical trial NCT03078855: A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma
Official title: ILyAD (Indolent Lymphoma And Vitamin D) A Phase III Double Blind, Randomized Trial to Evaluate the Effect of Vitamin D on Progression-free Survival in Patients With Low Tumor-burden Indolent Non-Hodgkin Lymphoma Treated With Rituximab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Follicular Lymphoma
Small Lymphocytic Lymphoma
Marginal Zone Lymphoma
Mucosal-Associated Lymphoid Tissue Lymphoma
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2017-03-13
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Event Free Survival
timeFrame: 3 years
Secondary outcomes:
measure: All-Cause Mortality
timeFrame: Participants were followed for survival beginning on day 1 of treatment until study closure with a maximum follow-up of 64 months.
measure: Number of Participants With Treatment Response at 13 Weeks
timeFrame: 13 Weeks from the start of treatment
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Atlanta
country: United States
facility: Emory University, Winship Cancer Institute
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Rochester
country: United States
facility: James P. Wilmot Cancer Institute at University of Rochester Medical Center
state: New York
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: James P. Wilmot Cancer Institute at University of Rochester
name: Jonathan W. Friedberg, MD
role: PRINCIPAL_INVESTIGATOR
References: