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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 hyperparathyroidism
  • Hypercalcemia (defined as above the institutional normal range)
  • History of calcium-related kidney stones
  • Creatinine > 1.5X above upper limit of normal
  • Women who are pregnant or who plan to become pregnant while on treatment

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Thomas Witzig, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions