N/A
N=179
Cholecalciferol in Newly Diagnosed Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia With Vitamin D Deficiency
Chronic Lymphocytic Leukemia · Non-Hodgkin Lymphoma · Untreated Chronic Lymphocytic Leukemia · Vitamin D Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT02553447 ↗Enrolled (actual)
179
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Progression-free Survival — 0.839; 0.893; 0.827 Proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cholecalciferol (Dietary_supplement); Laboratory Biomarker Analysis (Other)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Nebraska
- Primary completion
- Apr 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
0.839; 0.893; 0.827 | — |
| SECONDARY Incidence of Adverse Events and Serious Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 |
1; 0; 0 | — |
| SECONDARY Overall Survival |
0.860; 0.972; 0.942 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02553447). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.