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Vitamin D for Lymphoma

N/A

Waitlist Available

Led By Julie Vose

Research Sponsored by University of Nebraska

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

History of Paget?s disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well cholecalciferol works in treating patients with newly diagnosed non-Hodgkin lymphoma or chronic lymphocytic leukemia with low levels of vitamin D.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include issues related to high levels of vitamin D such as nausea, vomiting, constipation, weakness and serious complications like kidney damage; however specific side effects from this treatment aren't detailed.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of Paget's disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival

Secondary study objectives

Incidence of adverse events and serious events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Overall survival

Side effects data

From 2010 Phase 4 trial • 109 Patients • NCT01265615

23%

Hypophospatemia

17%

Fatigue

13%

Increased hypertension

13%

Edema

13%

Diarrhea

13%

Pain

10%

Taste perversions

10%

Arthritis

10%

Dizziness

10%

Gastroenteritis

10%

Vertigo

10%

Rhinitis

10%

Bronchitis

10%

Rash

Viral Infection

Leg Cramps

Hypercalcemia

Allergic Infection

Polydipsia

Dehydration

Urinary Tract Infection

Chest Pain

Sinusitis

Headache

General Infection

Asthenia

Fever

Infection Fungal

Conjuctivitis

Syncope

Depression

Increased Cough

Polyuria

Abdominal Pain

Photophobia

Decreased libido

Hypotension

Nausea

Esophageal ulcer

Somnolence

Back Pain

Vomiting

Pruritus

100%

80%

60%

40%

20%

Study treatment Arm

Paricalcitol Treatment

Calcitriol Treatment

Cholecalciferol

Supplemental

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cholecalciferol

2014

Completed Phase 4

~1100

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor

555 Previous Clinical Trials

1,145,189 Total Patients Enrolled

4 Trials studying Vitamin D Deficiency

663 Patients Enrolled for Vitamin D Deficiency

National Cancer Institute (NCI)NIH

13,957 Previous Clinical Trials

41,111,890 Total Patients Enrolled

2 Trials studying Vitamin D Deficiency

150 Patients Enrolled for Vitamin D Deficiency

Julie VosePrincipal InvestigatorUniversity of Nebraska

6 Previous Clinical Trials

231 Total Patients Enrolled

Julie M Vose, MD, MBA4.514 ReviewsPrincipal Investigator - University of Nebraska

University of Nebraska

1 Previous Clinical Trials

71 Total Patients Enrolled

5Patient Review

Dr Julie vose is my husband's oncologist. 2 years ago, her and Buffett cancer center nurses saved him from stage 4 hodgkins Lymphoma. It returned in February and he needs a stem cell transplant. I know her and this hospital are doing everything they can, she definitely gets down to business and doesn't sugar coat anything. No matter what my husband's outcome I know she and the nurses at Buffett will do everything they can to keep him alive. I am forever greatful and trust she is the best in omaha!