A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma (NCT03078855) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma
United States211 participantsStarted 2017-09-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 abov…