NCT02553447

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

A Pilot Study of Vitamin D Replacement in Patients With Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia With Low Vitamin D Levels

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This randomized pilot early phase I 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 description

PRIMARY OBJECTIVES: I. To evaluate the 3 year progression-free survival (PFS), defined as time from the time of study entry of watch and wait or 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 time from the time of study entry of watch and wait patients or newly diagnosed NHL or CLL 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.

Conditions

• Chronic Lymphocytic Leukemia
• Non-Hodgkin Lymphoma
• Untreated Chronic Lymphocytic Leukemia
• Vitamin D Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Cholecalciferol	Given PO
OTHER	Laboratory Biomarker Analysis	Optional correlative studies

Timeline

• Start date: 2015-10-19
• Primary completion: 2025-04-12
• Completion: 2025-04-12
• First posted: 2015-09-17
• Last updated: 2026-03-31
• Results posted: 2026-03-31

Locations

1 site across 1 country: United States