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

NCT ID: NCT02553447

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-19
• Study Completion Date: 2025-04-12

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I (high-dose cholecalciferol)

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

Group Type: EXPERIMENTAL

Cholecalciferol

Intervention Type: DIETARY_SUPPLEMENT

Given PO

Laboratory Biomarker Analysis

Intervention Type: OTHER

Optional correlative studies

Arm II (low-dose cholecalciferol)

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

Group Type: EXPERIMENTAL

Cholecalciferol

Intervention Type: DIETARY_SUPPLEMENT

Given PO

Laboratory Biomarker Analysis

Intervention Type: OTHER

Optional correlative studies

Arm III (control)

Patients receive no intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cholecalciferol

Given PO

Intervention Type: DIETARY_SUPPLEMENT

Laboratory Biomarker Analysis

Optional correlative studies

Intervention Type: OTHER

Other Intervention Names

9,10-Secocholesta-5,7,10(19)-trien-3-ol; Calciol; Delsterol; Vitamin D3

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie M Vose, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

NCI-2015-01502

Identifier Type: REGISTRY

Identifier Source: secondary_id

P30CA036727

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0556-15-FB

Identifier Type: -

Identifier Source: org_study_id