Cholecalciferol in Improving Survival in Patients With Newly Diagnosed Cancer With Vitamin D Insufficiency

Last updated: June 12, 2026
Sponsor: Mayo Clinic
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Lymphoma, B-cell

Chronic Lymphocytic Leukemia

T-cell Lymphoma

Treatment

Laboratory Biomarker Analysis

Cholecalciferol

Clinical Study ID

NCT01787409
LS1293
LS1293
12-007862
P50CA097274
NCI-2013-00037
  • Ages > 18
  • All Genders

Study Summary

This partially randomized clinical trial studies cholecalciferol in improving survival in patients with newly diagnosed cancer with vitamin D insufficiency. Vitamin D replacement may improve tumor response and survival and delay time to treatment in patients with cancer who are vitamin D insufficient.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Newly diagnosed aggressive lymphoma or CLL/small lymphocytic lymphoma (SLL) thatmeets disease specific criteria below:

  • Study 1 - Aggressive lymphoma

  • Newly diagnosed de-novo DLBCL or primary mediastinal B-cell lymphoma that willbe treated with an anthracycline-containing regimen (rituximab-cyclophosphamide, doxorubicin hydrochloride, prednisone [R-CHOP] orequivalent); patients with composite lymphomas can also be enrolled as long asthey have large cell component and will be treated with an anthracycline; inaddition, patients with "B cell lymphoma, unclassifiable, with featuresintermediate between diffuse large B cell lymphoma and Burkitt lymphoma" orpost-transplant DLBCL are also eligible as long as they meet other criteria;patients with typical Burkitt lymphoma are not eligible

  • NOTE: patients can be enrolled up through day 1 of cycle 3 of therapy; thepatient is permitted to participate in any other therapeutic therapy fortheir disease as long as it does not concern vitamin D; patients can begintheir chemotherapy while awaiting vitamin D results and treatment armassignment or

  • Newly diagnosed untreated peripheral T-cell non-Hodgkin lymphoma (NHL) thatwill be treated with chemotherapy; NOTE: patients can be enrolled up throughday 1 of cycle 3 of therapy; this includes the following disease types:

  • Peripheral T cell lymphoma, unspecified

  • Anaplastic large cell lymphoma (T and null cell type)

  • Extranodal NK/T-cell lymphoma, nasal type

  • Enteropathy-type T-cell lymphoma

  • Hepatosplenic T-cell lymphoma

  • Subcutaneous panniculitis-like T-cell lymphoma

  • Angioimmunoblastic T-cell lymphoma

  • Anaplastic large cell lymphoma - primary cutaneous type and

  • Willing to provide tissue for correlative research purposes

  • Study 2 - CLL/SLL

  • Newly diagnosed (< 12 months from pre-registration on this study) CLL accordingto the National Cancer Institute (NCI) criteria or SLL according to the WorldHealth Organization (WHO) criteria; this includes previous documentation of:

  • Biopsy-proven small lymphocytic lymphoma

  • Diagnosis of CLL according to NCI working group criteria as evidenced byall of the following:

  • Peripheral blood lymphocyte count of > 5,000/mm^3; if present,prolymphocytes should be < 55%

  • Immunophenotyping consistent with CLL defined as:

  • The predominant population of lymphocytes share both B-cellantigens (cluster of differentiation [CD]19, CD20, or CD23) aswell as CD5 in the absence of other pan-T-cell markers (CD3,CD2, etc.)

  • Dim surface immunoglobulin expression

  • Restricted surface kappa or lambda light chain expression

  • Before diagnosing CLL or SLL, mantle cell lymphoma must be excludedby demonstrating a negative fluorescent in situ hybridization (FISH)analysis for t(11;14)(immunoglobulin H [IgH]/cyclin D 1 [CCND1]) onperipheral blood or tissue biopsy or negative immunohistochemicalstains for cyclin D1 on involved tissue biopsy

  • Rai stage 0 or 1

  • Previously untreated

  • Asymptomatic with the plan for observation

  • Life expectancy of at least 24 months

  • Willing to provide tissue for correlative research purposes

  • Both Studies:

  • Capable of swallowing intact study medication capsules

  • Serum calcium < 11 mg/dL; note: patients with hypercalcemia can be enrolled afterthe calcium is corrected with standard of care treatments

  • Willing to return to enrolling institution for follow-up (during the activemonitoring phase of the study)

  • Note: During the Active Monitoring Phase of a study (i.e., active treatment andobservation), participants must be willing to return to the consentinginstitution for follow-up

  • Willing to provide blood samples for correlative research purposes

  • Vitamin D level (25 hydroxy D2 + hydroxyl D3) confirmed by central laboratory review

Exclusion

Exclusion Criteria:

  • Patients with Burkitt lymphoma or any patient receiving rituximab-cyclophosphamide,vincristine, doxorubicin, high-dose methotrexate / ifosfamide, etoposide, high-dosecytarabine (R- CODOXM/IVAC)

  • Patients who previously had indolent lymphoma and now at a separate episode havelarge cell NHL (i.e. transformation

Study Design

Total Participants: 565
Treatment Group(s): 2
Primary Treatment: Laboratory Biomarker Analysis
Phase:
Study Start date:
March 06, 2013
Estimated Completion Date:
June 30, 2028

Study Description

PRIMARY OBJECTIVES:

I. To determine if vitamin D replacement in vitamin D insufficient patients with newly diagnosed untreated diffuse large B-cell lymphoma (DLBCL) can improve event free survival at 12 months to be equivalent to that of a control population of vitamin D sufficient patients. (Study I) II. To assess the percentage of patients requiring treatment with conventional therapy at 36 in months in vitamin D insufficient patients with early stage chronic lymphocytic leukemia (CLL) being managed with observation who undergo vitamin D replacement. (Study II)

SECONDARY OBJECTIVES:

I. To assess the effect of vitamin D replacement in vitamin D insufficient patients with newly diagnosed untreated DLBCL on overall survival. (Study I) II. To assess the effect of vitamin D replacement in vitamin D insufficient patients with newly diagnosed untreated DLBCL on event free survival. (Study I) III. To assess the effect of vitamin D replacement in vitamin D insufficient patients with newly diagnosed untreated T cell lymphoma on event free and overall survival. (Study I) IV. To assess the effect of vitamin D replacement in vitamin D insufficient CLL patients on Bio-r response rate and overall response rate. (Study II) V. To assess time to treatment and overall survival in vitamin D insufficient CLL patients who received vitamin D replacement. (Study II)

TERTIARY OBJECTIVES:

I. To study immune effector cells (lymphocytes, monocytes), serum cytokines, and tumor cells from vitamin D deficient and sufficient patients to learn the effects of vitamin D on both tumor cells and the patient's immune system. (Study I-II)

OUTLINE:

Vitamin D sufficient patients receive no intervention. Vitamin D insufficient patients receive cholecalciferol orally (PO) once weekly for 12 weeks and then once monthly for a total of 36 months.

After completion of study treatment, patients are followed up for 2 years.

Connect with a study center

  • Mayo Clinic in Arizona

    Scottsdale, Arizona 85259
    United States

    Site Not Available

  • Emory University/Winship Cancer Institute

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis, Missouri 63110
    United States

    Site Not Available

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