Non Hodgkin Lymphoma Clinical Trial

A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin’s Lymphoma

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.

View Eligibility Criteria

Eligibility Criteria

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 above the institutional normal range (corrected for albumin when albumin levels are below normal)
History of calcium-related kidney stones
Creatinine > 1.5X above upper limit of normal
Women who are known to be pregnant or who plan to become pregnant while on rituximab treatment

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

211

Study ID:

NCT03078855

Recruitment Status:

Active, not recruiting

Sponsor:

Jonathan Friedberg

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There are 7 Locations for this study

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University of Miami
Miami Florida, 33136, United States
Emory University, Winship Cancer Institute
Atlanta Georgia, 30322, United States
University of Iowa
Iowa City Iowa, 52242, United States
Washington University
Saint Louis Missouri, 63130, United States
Weill Cornell Medical College
New York New York, 10021, United States
James P. Wilmot Cancer Institute at University of Rochester Medical Center
Rochester New York, 14642, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

211

Study ID:

NCT03078855

Recruitment Status:

Active, not recruiting

Sponsor:


Jonathan Friedberg

How clear is this clinincal trial information?

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