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

Running, not enrolling · Not applicable

Conditions studied: Aggressive Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-Cell Lymphoma, Chronic Lymphocytic Leukemia, Diffuse Large B-Cell Lymphoma, Enteropathy-Associated T-Cell Lymphoma, Hepatosplenic T-Cell Lymphoma, Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Mediastinal (Thymic) Large B-Cell Lymphoma, Nasal Type Extranodal NK/T-Cell Lymphoma, Peripheral T-Cell Lymphoma, Not Otherwise Specified, Primary Cutaneous Anaplastic Large Cell Lymphoma, Refractory Anaplastic Large Cell Lymphoma, Small Lymphocytic Lymphoma, Subcutaneous Panniculitis-Like T-Cell Lymphoma

In brief

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.

Key facts

Study ID

NCT01787409

Run by

Mayo Clinic

People needed

565

Starts

2013-03-06

Expected to finish

2028-06-30

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly diagnosed aggressive lymphoma or CLL/small lymphocytic lymphoma (SLL) that meets disease specific criteria below:
• 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 can also be enrolled as long as they have large cell component and will be treated with an anthracycline; in addition, patients with "B cell lymphoma, unclassifiable, with features intermediate between diffuse large B cell lymphoma and Burkitt lymphoma" or post-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; 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 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
• 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

You may not qualify if…

• Patients with Burkitt lymphoma or any patient receiving rituximab-cyclophosphamide, vincristine, doxorubicin, high-dose methotrexate / ifosfamide, etoposide, high-dose cytarabine (R- CODOXM/IVAC)
• Patients who previously had indolent lymphoma and now at a separate episode have large cell NHL (i.e. transformation

Where it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Emory University/Winship Cancer Institute — Atlanta, Georgia, United States
• University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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