Vitamin D for Lymphoma

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byJulie Vose

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Nebraska

No Placebo Group

Approved in 6 Jurisdictions

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.

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.

+1 more

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

+2 more

Participant Groups

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.

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (low-dose cholecalciferol)Experimental Treatment2 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 Treatment2 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 Control1 Intervention

Patients receive no intervention.