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

September 28, 2023 updated by: University of Nebraska

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

197

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University Of Nebraska Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (high-dose cholecalciferol)
Patients receive high-dose cholecalciferol PO daily for 3 years in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Optional correlative studies
Dietary supplement: Cholecalciferol
Given PO
Other Names:
  • Vitamin D3
  • 9,10-Secocholesta-5,7,10(19)-trien-3-ol
  • Calciol
  • Delsterol
Experimental: Arm II (low-dose cholecalciferol)
Patients receive low-dose cholecalciferol PO daily for 3 years in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Optional correlative studies
Dietary supplement: Cholecalciferol
Given PO
Other Names:
  • Vitamin D3
  • 9,10-Secocholesta-5,7,10(19)-trien-3-ol
  • Calciol
  • Delsterol
No Intervention: Arm III (control)
Patients receive no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 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
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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events and serious events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time Frame: Up to 30 days
Will be described for the low dose and high dose groups and compared between groups using a Chi-square. The frequency of occurrence of overall toxicity, categorized by toxicity grades, will be described for the low dose and high dose groups and compared between groups using a Chi-square.
Up to 30 days
Overall survival
Time Frame: 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
The 3-year overall 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 overall survival of 80% using a one-sample logrank test following the method of Woolson (1981).
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Julie M Vose, MD, MBA, University of Nebraska

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2015

Primary Completion (Estimated)

March 24, 2025

Study Completion (Estimated)

March 24, 2025

Study Registration Dates

First Submitted

September 16, 2015

First Submitted That Met QC Criteria

September 16, 2015

First Posted (Estimated)

September 17, 2015

Study Record Updates

Last Update Posted (Actual)

October 2, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0556-15-FB
  • P30CA036727 (U.S. NIH Grant/Contract)
  • NCI-2015-01502 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vitamin D Deficiency

Clinical Trials on Laboratory Biomarker Analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe