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

  • STATUS
    Recruiting
  • End date
    Nov 30, 2021
  • participants needed
    713
  • sponsor
    Mayo Clinic
Updated on 27 January 2021
cancer
calcium
cyclophosphamide
chronic lymphocytic leukemia
lymphoma
hodgkin's disease
rituximab
prednisone
treatment regimen
doxorubicin
burkitt's lymphoma
anthracyclines
diffuse large b-cell lymphoma
b-cell lymphoma
mantle cell lymphoma
cluster of differentiation
immunoglobulin
enteropathy
panniculitis
t-cell lymphoma
peripheral t-cell lymphoma
angioimmunoblastic t-cell lymphoma
anaplastic large cell lymphoma
large cell lymphoma
hepatosplenic t-cell lymphoma
cyclin d1
extranodal nk/t-cell lymphoma, nasal type
intestinal t-cell lymphoma
extranodal nk/t-cell lymphoma

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.

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.

Details
Condition Primary cutaneous anaplastic large cell lymphoma, Angiocentric T-cell lymphoma, Diffuse Large B-Cell Lymphoma, Peripheral T-Cell Lymphoma, cutaneous T-cell lymphoma, anaplastic large cell lymphoma, Enteropathy-Associated T-Cell Lymphoma, Chronic Lymphocytic Leukemia, T-Cell Lymphoma, Angioimmunoblastic Lymphadenopathy, Lymphocytic Leukemia, Chronic, Aggressive Non-Hodgkin Lymphoma, Hepatosplenic T-Cell Lymphoma, Mediastinal (Thymic) Large B-Cell Lymphoma, Refractory Anaplastic Large Cell Lymphoma, Subcutaneous Panniculitis-Like T-Cell Lymphoma, Subcutaneous Panniculitis Like T Cell Lymphoma, Aggressive Non-Hodgkin Lymphoma, Hepatosplenic T-Cell Lymphoma, Mediastinal (Thymic) Large B-Cell Lymphoma, Aggressive Non-Hodgkin Lymphoma, Hepatosplenic T-Cell Lymphoma, Mediastinal (Thymic) Large B-Cell Lymphoma, Aggressive Non-Hodgkin Lymphoma, Hepatosplenic T-Cell Lymphoma, Mediastinal (Thymic) Large B-Cell Lymphoma, Aggressive Non-Hodgkin Lymphoma, Hepatosplenic T-Cell Lymphoma, Mediastinal (Thymic) Large B-Cell Lymphoma, intestinal t-cell lymphoma, leukemia chronic lymphocytic, chronic lymphocytic leukemia (cll), small lymphocytic lymphoma, diffuse large cell lymphoma, diffuse large b cell lymphoma, b-cell small lymphocytic lymphoma, Aggressive Non-Hodgkin Lymphoma, Hepatosplenic T-Cell Lymphoma, Mediastinal (Thymic) Large B-Cell Lymphoma, Aggressive Non-Hodgkin Lymphoma, Hepatosplenic T-Cell Lymphoma, Mediastinal (Thymic) Large B-Cell Lymphoma, Aggressive Non-Hodgkin Lymphoma, Hepatosplenic T-Cell Lymphoma, Mediastinal (Thymic) Large B-Cell Lymphoma
Treatment laboratory biomarker analysis, Cholecalciferol, Cholecalciferol
Clinical Study IdentifierNCT01787409
SponsorMayo Clinic
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Chronic Lymphocytic Leukemia or Hepatosplenic T-Cell Lymphoma or T-Cell Lymphoma or Lymphocytic Leukemia, Chronic or Refractory Anaplastic Large Cell ...?
Do you have any of these conditions: Lymphocytic Leukemia, Chronic or diffuse large b cell lymphoma or Mediastinal (Thymic) Large B-Cell Lymphoma or intestinal t-cell lymphoma or cutaneou...?
Do you have any of these conditions: Chronic Lymphocytic Leukemia or Lymphocytic Leukemia, Chronic or diffuse large cell lymphoma or Hepatosplenic T-Cell Lymphoma or leukemia chronic lymp...?
Do you have any of these conditions: Angioimmunoblastic Lymphadenopathy or Lymphocytic Leukemia, Chronic or diffuse large b cell lymphoma or T-Cell Lymphoma or Angiocentric T-cell lymphom...?
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
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 after the calcium is corrected with standard of care treatments
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
Willing to provide blood samples for correlative research purposes
Vitamin D level (25 hydroxy D2 + hydroxyl D3) confirmed by central laboratory review
Clear my responses

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