Using vitamin D to improve survival in cancer patients with low vitamin D levels
Effect of Vitamin D Replacement on Tumor Response and Survival Parameters for Vitamin D Insufficient Patients With Cancer
This study is testing if giving vitamin D to cancer patients with low levels can help them live longer and have better outcomes compared to those with normal vitamin D levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | rituximab, chemotherapy, cyclophosphamide, doxorubicin, prednisone |
| Locations | 5 sites (Scottsdale, Arizona and 4 other locations) |
| Trial ID | NCT01787409 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of cholecalciferol (vitamin D3) on survival rates in patients newly diagnosed with aggressive lymphomas and chronic lymphocytic leukemia who are vitamin D insufficient. The study aims to determine if vitamin D replacement can enhance event-free survival and overall survival compared to patients with sufficient vitamin D levels. It includes both primary and secondary objectives focusing on various lymphoma types and treatment responses. Participants will receive vitamin D supplementation and undergo laboratory biomarker analysis to assess immune responses and treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients newly diagnosed with aggressive non-Hodgkin lymphoma or chronic lymphocytic leukemia who are found to have low vitamin D levels.
Not a fit: Patients with typical Burkitt lymphoma or those already receiving treatment for their cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and treatment outcomes for cancer patients with vitamin D insufficiency.
How similar studies have performed: While the specific approach of using vitamin D in this context is novel, there is emerging evidence suggesting that vitamin D may play a role in cancer treatment outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 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
Where this trial is running
Scottsdale, Arizona and 4 other locations
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Active_not_recruiting)
- Emory University/Winship Cancer Institute — Atlanta, Georgia, United States (Active_not_recruiting)
- University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Washington University School of Medicine — Saint Louis, Missouri, United States (Active_not_recruiting)
Study contacts
- Principal investigator: Thomas Witzig — Mayo Clinic
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.