Clinical trial · Interventional
A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma
ILyAD (Indolent Lymphoma And Vitamin D) A Phase III Double Blind, Randomized Trial to Evaluate the Effect of Vitamin D on Progression-free Survival in Patients With Low Tumor-burden Indolent Non-Hodgkin Lymphoma Treated With Rituximab
NCT03078855CI-TRIAL-00080405ILyADcompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Marginal Zone Lymphoma | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Mucosal-Associated Lymphoid Tissue Lymphoma | Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | ALIAS | 0.90 |
| Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| Rituximab | Biological | Rituximab | ALIAS |
| Vitamin D | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vitamin D plus rituximab
- description
- Rituximab was administered weekly x 4 (intravenous 375 mg/m\^2 or subcutaneous equivalent) per institutional standards and vitamin D3, 2000 IU orally once daily. Participants took vitamin D3 until lack of response at week 13, disease progression, or initiation of a new treatment.
- interventionNames
- Dietary Supplement: Vitamin D
- Biological: Rituximab
- type
- PLACEBO_COMPARATOR
- label
- Placebo plus rituximab
- description
- Rituximab was administered weekly x 4 (intravenous 375 mg/m\^2 or subcutaneous equivalent) per institutional standards and placebo orally once daily. Participants took placebo until lack of response at week 13, disease progression, or initiation of a new treatment.
- interventionNames
- Biological: Rituximab
- Other: Placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDFriedberg JW, Brady MT, Strawderman M, Kahl BS, Lossos IS, Cohen JB, Reagan PM, Casulo C, Averill BL, Baran A, Sutamtewagul G, Barr PM, Leonard JP, Ashton JM, Strang JG, Vega F, Peterson DR, Nastoupil LJ. Vitamin D in patients with low tumor-burden indolent non-Hodgkin lymphoma treated with rituximab therapy (ILyAD): a randomized, phase 3 clinical trial. EClinicalMedicine. 2024 Nov 27;78:102959. doi: 10.1016/j.eclinm.2024.102959. eCollection 2024 Dec. PMID 39677358