Last updated on March 2016

Cholecalciferol in Treating Patients With Newly Diagnosed Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia With Vitamin D Deficiency


Brief description of study

This randomized phase II trial studies how well cholecalciferol works in treating patients with newly diagnosed non-Hodgkin lymphoma or chronic lymphocytic leukemia with low levels of vitamin D (vitamin D deficiency). Cholecalciferol may increase levels of vitamin D and improve survival in patients with non-Hodgkin lymphoma or chronic lymphocytic leukemia receiving standard of care chemotherapy.

Detailed Study Description

PRIMARY OBJECTIVES: I. To evaluate the 3 year progression-free survival (PFS), defined as time from the first chemotherapy for the treatment of newly diagnosed non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL) until relapse, progression, or death from any cause. SECONDARY OBJECTIVES: I. To evaluate changes in the levels of serum vitamin D levels during therapy with daily oral vitamin D supplementation (cholecalciferol). II. To evaluate the overall survival (OS), defined as defined as time from the first chemotherapy for the treatment of newly diagnosed NHL or CLL administered on trial until death from any cause. OUTLINE: Patients with low levels of vitamin D are randomized to 1 of 2 arms and patients with normal levels are assigned to Arm III. ARM I: Patients receive high-dose cholecalciferol orally (PO) daily for 3 years in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive low-dose cholecalciferol PO daily for 3 years in the absence of disease progression or unacceptable toxicity. ARM III: Patients receive no intervention.

Clinical Study Identifier: NCT02553447

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Julie M. Vose

University of Nebraska Medical Center
Omaha, NE United States
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