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

Cancer Type
Trial Phase
18 Years and older, Male and Female
Study Type
Protocol IDs
LS1293 (primary)
Study Sponsor
Mayo Clinic in Rochester


This 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.


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)

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)

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)

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.


  2. Provide informed written consent
  3. Submission of sample to central lab for Vitamin D assay; this review is mandatory prior to registration to confirm vitamin level; it should be initiated as soon after pre-registration as possible; Note: for Mayo sites this will be ordered through the clinical lab and for all other sites a portion of the research sample will be used
  5. Newly diagnosed aggressive lymphoma or CLL/small lymphocytic lymphoma (SLL) that meets disease specific criteria below:
  6. Study 1 - Aggressive lymphoma * Newly diagnosed de-novo DLBCL or primary mediastinal B-cell lymphoma that will be treated with an anthracycline-containing regimen (rituximab-cyclophosphamide, doxorubicin hydrochloride, prednisone [R-CHOP] or equivalent) * Patients with composite lymphomas (low grade and large cell; marginal and large cell; nodular lymphocyte predominant [LP] Hodgkin and large cell, etc) at the time of original diagnosis can also be enrolled as long as they have large cell component and will be treated with an anthracycline * Patients with high-grade B-cell lymphoma with rearrangements of MYC and BCL2 and/or BCL6 (formerly DLBCL with double or triple hit), high-grade B-cell lymphoma, not otherwise specified (NOS), B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma, and post-transplant DLBCL are also eligible as long as they meet other criteria and are receiving RCHOP-based therapy ** NOTE: patients can be enrolled up through day 1 of cycle 3 of therapy; the patient is permitted to participate in any other therapeutic therapy for their disease as long as it does not concern vitamin D; patients can begin their chemotherapy while awaiting vitamin D results and treatment arm assignment or * Newly diagnosed untreated peripheral T-cell non-Hodgkin lymphoma (NHL) that will be treated with any chemotherapy; NOTE: patients can be enrolled up through day 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
  7. Study 2 - CLL/SLL * Newly diagnosed (< 12 months from pre-registration on this study) CLL according to the National Cancer Institute (NCI) criteria or SLL according to the World Health Organization (WHO) criteria; this includes previous documentation of: ** Biopsy-proven small lymphocytic lymphoma ** Diagnosis of CLL according to NCI working group criteria as evidenced by all 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-cell antigens (cluster of differentiation [CD]19, CD20, or CD23) as well 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 excluded by demonstrating a negative fluorescent in situ hybridization (FISH) analysis for t(11;14)(immunoglobulin H [IgH]/cyclin D 1 [CCND1]) on peripheral blood or tissue biopsy or negative immunohistochemical stains 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
  8. Both Studies:
  9. Capable of swallowing intact study medication capsules
  10. Serum calcium < 11 mg/dL, obtained =< 42 days prior to registration; note: patients with hypercalcemia can be enrolled after the calcium is corrected with standard of care treatments
  11. Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) * Note: During the Active Monitoring Phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up
  12. Willing to provide blood samples for correlative research purposes
  13. Vitamin D level (25 hydroxy D2 + hydroxyl D3) confirmed by central laboratory review

Treatment Sites in Georgia

Winship Cancer Institute of Emory University

1365 Clifton Road NE
Building C
Atlanta, GA 30322

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.