Recruitment

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