Cholecalciferol in Improving Survival in Patients With Newly Diagnosed Cancer With Vitamin D Insufficiency
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 965
Summary
- Conditions
- Anaplastic Large Cell Lymphoma
- Aggressive Non-Hodgkin Lymphoma
- Angioimmunoblastic T Cell Lymphoma
- Chronic Lymphocytic Leukemia
- Refractory Anaplastic Large Cell Lymphoma
- Diffuse Large B Cell Lymphoma
- Primary Cutaneous Anaplastic Large Cell Lymphoma
- Enteropathy Associated T Cell Lymphoma
- Hepatosplenic T Cell Lymphoma
- Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
- Mediastinal (Thymic) Large B-Cell Lymphoma
- Small Lymphocytic Lymphoma
- Subcutaneous Panniculitis Like T Cell Lymphoma
- Nasal Type Extranodal NK/T-Cell Lymphoma
- Peripheral T-cell Lymphoma (Not Otherwise Specified)
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To determine if vitamin D replacement in vitamin D insufficient patients with newly diagnosed untreated diffuse large B-cell lymphoma (DLBCL) can improve event free survival at 12 months to be equivalent to that of a control population of vitamin D sufficient patients. (Study ...
PRIMARY OBJECTIVES: I. To determine if vitamin D replacement in vitamin D insufficient patients with newly diagnosed untreated diffuse large B-cell lymphoma (DLBCL) can improve event free survival at 12 months to be equivalent to that of a control population of vitamin D sufficient patients. (Study I) II. To assess the percentage of patients requiring treatment with conventional therapy at 36 in months in vitamin D insufficient patients with early stage chronic lymphocytic leukemia (CLL) being managed with observation who undergo vitamin D replacement. (Study II) SECONDARY OBJECTIVES: I. To assess the effect of vitamin D replacement in vitamin D insufficient patients with newly diagnosed untreated DLBCL on overall survival. (Study I) II. To assess the effect of vitamin D replacement in vitamin D insufficient patients with newly diagnosed untreated DLBCL on event free survival. (Study I) III. To assess the effect of vitamin D replacement in vitamin D insufficient patients with newly diagnosed untreated T cell lymphoma on event free and overall survival. (Study I) IV. To assess the effect of vitamin D replacement in vitamin D insufficient CLL patients on Bio-r response rate and overall response rate. (Study II) V. To assess time to treatment and overall survival in vitamin D insufficient CLL patients who received vitamin D replacement. (Study II) TERTIARY OBJECTIVES: I. To study immune effector cells (lymphocytes, monocytes), serum cytokines, and tumor cells from vitamin D deficient and sufficient patients to learn the effects of vitamin D on both tumor cells and the patient's immune system. (Study I-II) OUTLINE: Vitamin D sufficient patients receive no intervention. Vitamin D insufficient patients receive cholecalciferol orally (PO) once weekly for 12 weeks and then once monthly for a total of 36 months. After completion of study treatment, patients are followed up for 2 years.
Tracking Information
- NCT #
- NCT01787409
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Thomas Witzig Mayo Clinic