Principal Investigator
Enrollment Status
Clinical Trial ID
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.
Phase
Phase 3
Funding Agency/Sponsor
Externally Peer-Reviewed
Disease
Lymphoma
Enrollment 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