Clinical Trials /

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

NCT03078855

Description:

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.

Related Conditions:
  • Follicular Lymphoma
  • Marginal Zone Lymphoma
  • Small Lymphocytic Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT03078855

Trial Eligibility

Document

Title

  • Brief Title: 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 Supplemental Effect of Vitamin D on Progression-free Survival in Patients With Low Tumor-burden Indolent Non-Hodgkin Lymphoma Treated With Rituximab

Clinical Trial IDs

  • ORG STUDY ID: 66593
  • SECONDARY ID: R01CA214890
  • NCT ID: NCT03078855

Conditions

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

Interventions

DrugSynonymsArms
RituximabRituxanPlacebo plus rituximab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Vitamin D plus rituximabExperimental
  • Rituximab
Placebo plus rituximabPlacebo Comparator
  • Rituximab

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
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Time to progression or death
Time Frame:Year three
Safety Issue:
Description:Mean time to death or progression defined as increase in lymphoma burden by at least 50%

Secondary Outcome Measures

Measure:Time from randomization to death
Time Frame:Year three
Safety Issue:
Description:Mean time to death
Measure:Response to rituximab defined as reduction of lymphoma burden by at least 50%
Time Frame:13 weeks
Safety Issue:
Description:Response is defined as reduction of lymphoma burden by at least 50%

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Jonathan Friedberg

Last Updated

March 3, 2021