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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA214890 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D plus rituximab | Experimental | 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. |
|
| Placebo plus rituximab | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement | vitamin D3 2,000 IU daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event Free Survival | Event free survival (EFS) was defined as the time from randomization to lack of response at week 13, initiation of a new treatment, disease progression defined by Lugano criteria, or death, right-censored by time of last follow-up. Per Lugano criteria, progression is defined as a new FDG-avid lesion or an increase in intensity from baseline, an increase by >= 50% in lesion diameters, a new lymph node > 1.5 cm in any axis or a new extranodal site > 1.0 cm. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| All-Cause Mortality | Number of participants who died from any cause between day 1 of treatment and the time of last follow-up. | Participants were followed for survival beginning on day 1 of treatment until study closure with a maximum follow-up of 64 months. |
| Number of Participants With Treatment Response at 13 Weeks |
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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:
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:
Exclusion Criteria:
The following criteria will prevent inclusion of an inappropriate subject into the trial:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan W. Friedberg, MD | James P. Wilmot Cancer Institute at University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States | ||
| Emory University, Winship Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39677358 | Derived | Friedberg 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. |
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De-identified data will be made available to researchers upon reasonable request.
Data requests will be considered beginning in December 2024.
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Participants were enrolled at 7 US academic medical centers between September 2017 and March 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D Plus Rituximab | 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. Vitamin D: vitamin D3 2,000 IU daily Rituximab: Administered weekly x 4 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2020 |
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| Rituximab | Biological | Administered weekly x 4 |
|
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| Placebo | Other | methylcellulose |
|
Participants had imaging performed at week 13 to assess response to treatment. A response was defined as partial (PR) or complete response (CR) according to Lugano criteria. Per Lugano criteria for target lesions: PR includes reduced metabolic uptake or a ≥ 50% decrease in the sum of the products of the diameters compared to baseline. CR includes metabolic score of 1, 2 or 3 (out of 5) with or without residual mass or regression of target lesions to ≤ 1.5 cm in the longest dimension. |
| 13 Weeks from the start of treatment |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Washington University | St 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 |
| FG001 | Placebo Plus Rituximab | 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. Placebo: methylcellulose Rituximab: Administered weekly x 4 |
| COMPLETED |
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| NOT COMPLETED |
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The baseline analysis population included randomized and eligible participants that received at least one dose of vitamin D or placebo. Five enrolled participants were either ineligible or withdrew before receiving at least one dose of vitamin D or placebo and were excluded from the baseline analysis population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D Plus Rituximab | Rituximab was administered weekly x 4 (intravenous 375 mg/m^2 or subcutaneous equivalent) per institutional standards and vitamin D3, 2000 IU, was taken orally once daily. Participants took vitamin D3 until lack of response at week 13, disease progression, or initiation of a new treatment. |
| BG001 | Placebo Plus Rituximab | Rituximab was administered weekly x 4 (intravenous 375 mg/m^2 or subcutaneous equivalent) per institutional standards and placebo was taken orally once daily. Participants took placebo until lack of response at week 13, disease progression, or initiation of a new treatment. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Event Free Survival | Event free survival (EFS) was defined as the time from randomization to lack of response at week 13, initiation of a new treatment, disease progression defined by Lugano criteria, or death, right-censored by time of last follow-up. Per Lugano criteria, progression is defined as a new FDG-avid lesion or an increase in intensity from baseline, an increase by >= 50% in lesion diameters, a new lymph node > 1.5 cm in any axis or a new extranodal site > 1.0 cm. | The analysis population included randomized and eligible participants that received at least one dose of vitamin D or placebo. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 3 years |
|
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| Secondary | All-Cause Mortality | Number of participants who died from any cause between day 1 of treatment and the time of last follow-up. | The analysis population included randomized and eligible participants that received at least one dose of vitamin D or placebo. | Posted | Count of Participants | Participants | Participants were followed for survival beginning on day 1 of treatment until study closure with a maximum follow-up of 64 months. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Response at 13 Weeks | Participants had imaging performed at week 13 to assess response to treatment. A response was defined as partial (PR) or complete response (CR) according to Lugano criteria. Per Lugano criteria for target lesions: PR includes reduced metabolic uptake or a ≥ 50% decrease in the sum of the products of the diameters compared to baseline. CR includes metabolic score of 1, 2 or 3 (out of 5) with or without residual mass or regression of target lesions to ≤ 1.5 cm in the longest dimension. | The analysis population included randomized and eligible participants that received at least one dose of vitamin D or placebo and were evaluated for treatment response at 13 weeks. | Posted | Count of Participants | Participants | 13 Weeks from the start of treatment |
|
Adverse events and serious adverse events were evaluated beginning on day 1 of treatment through 30 days after the last dose of vitamin D or placebo, up to 37 months. All-cause mortality was evaluated beginning on day 1 of treatment until study closure with a maximum follow-up of 64 months.
Adverse events were collected through chart review and participant solicitation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin D Plus Rituximab | Rituximab was administered weekly x 4 (intravenous 375 mg/m^2 or subcutaneous equivalent) per institutional standards and vitamin D3, 2000 IU, was taken orally once daily. Participants took vitamin D3 until lack of response at week 13, disease progression, or initiation of a new treatment. | 4 | 135 | 16 | 135 | 111 | 135 |
| EG001 | Placebo Plus Rituximab | Rituximab was administered weekly x 4 (intravenous 375 mg/m^2 or subcutaneous equivalent) per institutional standards and placebo was taken orally once daily. Participants took placebo until lack of response at week 13, disease progression, or initiation of a new treatment. | 3 | 71 | 9 | 71 | 54 | 71 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion related reaction | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Aortic valve disease | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chest pain | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Heart failure | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other - Hemothorax | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other - Vision changes | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemorrhoidal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Other - COVID19 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Other - Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
| |
| Other - Gastric adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
| |
| Other - Pancreatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Stroke | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Renal calculi | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infusion related reaction | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Injection site reaction | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other - COVID19 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Brady, PhD | University of Rochester | 585-275-5830 | michael_brady@urmc.rochester.edu |
| Jul 8, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 2, 2021 | Jul 8, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016393 | Lymphoma, B-Cell |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|