Clinical trial NCT02553447: Cholecalciferol in Newly Diagnosed Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia With Vitamin D Deficiency
Official title: A Pilot Study of Vitamin D Replacement in Patients With Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia With Low Vitamin D Levels
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma
Untreated Chronic Lymphocytic Leukemia
Vitamin D Deficiency
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-09-17
Enrollment: 197
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: Progression-free survival
timeFrame: 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 outcomes:
measure: Incidence of adverse events and serious events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
timeFrame: Up to 30 days
measure: Overall survival
timeFrame: 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
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Julie M Vose, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: