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

NCT02553447 | Completed Results DMC

• 3 other identifiers: 0556-15-FBNCI-2015-01502P30CA036727
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  The 3-year progression-free survival will be presented using Kaplan-Meier curves and will be presented for the normal serum vitamin D control group and the low and high dose randomized groups. Each randomized group (low and high dose) will be compared to a historical fixed expected 3-year progression-free survival of 45% using a one-sample logrank test following the method of Woolson (1981). Progression was determined by Investigator assessment based on clinical evidence of disease relapse, progression requiring new therapy, or death from any cause.

  Time from the time of study entry of watch and wait or diagnosed non-Hodgkin lymphoma or chronic lymphocytic leukemia until relapse, progression, or death from any cause, assessed at 3 years

Secondary Outcomes (2)

• Incidence of Adverse Events and Serious Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

  Up to 30 days

• Overall Survival

  Time from the time of study entry of watch and wait or newly diagnosed non-Hodgkin lymphoma or chronic lymphocytic leukemia administered on trial until death from any cause, assessed at 3 years

Study Arms (3)

Arm I (high-dose cholecalciferol)

EXPERIMENTAL

Patients receive high-dose cholecalciferol PO daily for 3 years in the absence of disease progression or unacceptable toxicity.

Dietary Supplement: Cholecalciferol; Other: Laboratory Biomarker Analysis

Arm II (low-dose cholecalciferol)

EXPERIMENTAL

Patients receive low-dose cholecalciferol PO daily for 3 years in the absence of disease progression or unacceptable toxicity.

Dietary Supplement: Cholecalciferol; Other: Laboratory Biomarker Analysis

Arm III (control)

NO INTERVENTION

Patients receive no intervention.

Interventions

Cholecalciferol DIETARY_SUPPLEMENT

Given PO

Also known as: 9,10-Secocholesta-5,7,10(19)-trien-3-ol, Calciol, Delsterol, Vitamin D3

Arm I (high-dose cholecalciferol); Arm II (low-dose cholecalciferol)

Laboratory Biomarker Analysis OTHER

Optional correlative studies

Arm I (high-dose cholecalciferol); Arm II (low-dose cholecalciferol)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically confirmed newly diagnosed or previously untreated (patients may be under no treatment ?wait and watch? or have received two cycles of chemotherapy or localized radiation therapy before going on this study) non-Hodgkin?s lymphoma or CLL
• Patients must have serum 25-hydroxyvitamin D (25\[OH\]D) drawn at time of enrollment; (NOTE: subjects currently taking vitamin D supplements are eligible for screening)
• Simultaneous participation in other therapeutic clinical trials will be allowed
• Patients must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts

You may not qualify if:

• History of uncontrollable allergic reactions to vitamin D
• History of Paget?s disease
• Hypercalcemia
• Any other clinically significant medical disease or condition laboratory abnormality or psychiatric illness that, in the investigator?s opinion, may interfere with protocol adherence or a subject?s ability to give informed consent
• Inability to cooperate with the requirements of the protocol

Sponsors & Collaborators

• University of Nebraska: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Non-Hodgkin; Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Dr. Julie M. Vose
• Organization: University of Nebraska medicine

IITOffice@unmc.edu

4025595669

Study Officials

• Julie M Vose, MD, MBA

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2015
• First Posted: September 17, 2015
• Study Start: October 19, 2015
• Primary Completion: April 12, 2025
• Study Completion: April 12, 2025
• Last Updated: April 21, 2026
• Results First Posted: March 31, 2026

Record last verified: 2024-10

Locations

US (1)