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

Follicular Lymphoma Clinical Trial

— ILyAD  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03078855
• Other study ID #: 66593
• Secondary ID: R01CA214890
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 7, 2017
• Est. completion date: September 2024

Study information

• Verified date: June 2024
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 211
• Est. completion date: September 2024
• Est. primary completion date: July 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Follicular Lymphoma
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma
• Lymphoma, B-Cell, Marginal Zone
• Lymphoma, Non-Hodgkin
• Marginal Zone Lymphoma
• Mucosal-Associated Lymphoid Tissue Lymphoma
• Small Lymphocytic Lymphoma

Intervention

Dietary Supplement:
• Vitamin D
vitamin D3 2,000 IU daily

Biological:
• Rituximab
Administered weekly x 4

Other:
• Placebo
methylcellulose

Locations

Country	Name	City	State
United States	Emory University, Winship Cancer Institute	Atlanta	Georgia
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	University of Miami	Miami	Florida
United States	Weill Cornell Medical College	New York	New York
United States	James P. Wilmot Cancer Institute at University of Rochester Medical Center	Rochester	New York
United States	Washington University	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Jonathan Friedberg	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event Free Survival	The event free survival (EFS) hazard ratio was adjusted for enrolling site, continuous age at randomization, and (via stratification) three randomization strata: non-follicular histology, follicular histology with low/medium FLIPI score and follicular histology with high FLIPI score. EFS was defined as the time from randomization to lack of response at week 13, initiation of a new treatment, disease progression defined by Lugano criteria, or death, right-censored by time of last follow-up. Per Lugano criteria, progression is defined as a new FDG-avid lesion or an increase in intensity from baseline, an increase by >= 50% in lesion diameters, a new lymph node > 1.5 cm in any axis or a new extranodal site > 1.0 cm.	3 years
Secondary	All-Cause Mortality	Number of participants who died from any cause between randomization and the time of last follow-up.	Participants were followed for surival from randomization until study closure with a maximum follow-up of 64 months.
Secondary	Number of Participants with Treatment Response at 13 Weeks	Participants had imaging performed at week 13 to assess response to treatment. A response was defined as partial (PR) or complete response (CR) according to Lugano criteria. Per Lugano criteria for target lesions: PR includes reduced metabolic uptake or a = 50% decrease in the sum of the products of the diameters compared to baseline. CR includes metabolic score of 1, 2 or 3 with or without residual mass or regression of target lesions to = 1.5 cm in the longest dimension.	13 Weeks from the start of treatment