Vitamin D for Lymphoma

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska

Disqualifiers: Allergic reactions, Paget's disease, Hypercalcemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 years

197 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Julie M Vose, MD, MBA

Principal Investigator

University of Nebraska

Eligibility Criteria

This trial is for newly diagnosed or untreated patients with non-Hodgkin lymphoma or chronic lymphocytic leukemia who also have vitamin D deficiency. They can join even if they're on 'wait and watch' therapy, had up to two chemo cycles, or localized radiation. However, those with a history of severe allergic reactions to vitamin D, Paget's disease, high calcium levels in the blood, or conditions that could affect protocol adherence cannot participate.

Inclusion Criteria

I have newly diagnosed or untreated non-Hodgkin’s lymphoma or CLL.

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 can participate in other clinical trials for different treatments at the same time.

Exclusion Criteria

You have any other medical condition or mental illness that may make it difficult for you to follow the study protocol or understand the information provided to you.

Inability to cooperate with the requirements of the protocol

Hypercalcemia

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either high-dose or low-dose cholecalciferol orally daily for 3 years

3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cholecalciferol

Trial Overview The study tests how well Cholecalciferol (a form of Vitamin D) works alongside standard chemotherapy in improving survival rates for patients with certain types of leukemia and lymphoma who are deficient in Vitamin D. It's an early phase I trial where some participants will receive Cholecalciferol while their responses are monitored through lab analysis.

Participant Groups

Group I: Arm II (low-dose cholecalciferol) Experimental Treatment 2 Interventions

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

Group II: Arm I (high-dose cholecalciferol) Experimental Treatment 2 Interventions

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

Group III: Arm III (control) Active Control 1 Intervention

Patients receive no intervention.

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+