A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma (NCT03078855) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma
United States211 participantsStarted 2017-09-07
Plain-language summary
Despite strong evidence suggesting that vitamin D deficiency is associated with undesirable outcomes in patients with numerous cancers, there has never been a thorough study of vitamin D treatment in subjects undergoing treatment for cancer. The purpose of this study is to evaluate whether modification of vitamin D levels in the blood, through supplementation, can improve outcomes.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Each of the following criteria must be met in order for a patient to be considered eligible for registration:
* Biopsy proven (with hematopathology review at one of the participating sites to confirm correct histology in accordance with World Health Organization) indolent lymphoma to include the following diagnoses:
* Grade 1, 2, or 3a follicular lymphoma
* Small lymphocytic lymphoma (CLL excluded)
* Marginal zone lymphoma (nodal or splenic)
* Mucosal-associated lymphoid tissue
* Measurable disease defined by Lugano criteria
* No prior anti-lymphoma systemic therapy; prior radiation therapy allowed
* Age 18 or over
* Ann Arbor stages II, III or IV
* Patients with follicular lymphoma must have PET FDG-avid lymphoma and fulfill Low tumor burden by Groupe D'Etude des Lymphomes Folliculaires (GELF) criteria:
* No mass \> 7 cm
* \< 3 distinct masses of greater than 3 cm
* No B symptoms
* No splenomegaly \> 16 cm by computed tomography (CT) scan
* No risk of vital organ compression
* No leukemic phase \> 5000/µl circulating lymphocytes (except for in patients with splenic marginal zone diagnosis)
* No cytopenias (platelets \< 100,000/µl, hemoglobin \< 10 g/dl, or absolute neutrophil count \< 1500/µl)
Exclusion Criteria:
The following criteria will prevent inclusion of an inappropriate subject into the trial:
* Osteoporosis requiring prescription treatment
* Known symptomatic primary hyperparathyroidism
* Hypercalcemia defined as abov…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.