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The goal of this clinical trial is to evaluate whether a high-intensity loading dose of ergocalciferol (vitamin D2) can normalize blood vitamin D levels more rapidly and safely than standard weekly dosing in patients with newly diagnosed aggressive non-Hodgkin lymphoma. The study will also assess the safety of both dosing strategies.
The main questions it aims to answer are:
Researchers will compare a high-intensity loading dose regimen of ergocalciferol with a standard weekly dosing regimen to determine differences in vitamin D normalization and safety outcomes.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Dose Loading Ergocalciferol | Experimental | Participants receive a high-dose loading regimen of ergocalciferol (vitamin D₂) for rapid normalization of serum vitamin D levels, in combination with standard first-line chemoimmunotherapy for aggressive non-Hodgkin lymphoma. |
|
| Standard Weekly Ergocalciferol | Active Comparator | Participants receive standard weekly dosing of ergocalciferol (vitamin D₂) for vitamin D normalization, in combination with standard first-line chemoimmunotherapy for aggressive non-Hodgkin lymphoma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Dose Loading Ergocalciferol | Drug | Dose and Schedule:
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Achieving Vitamin D Normalization by Day 21 | Vitamin D normalization is defined as a serum 25-hydroxyvitamin D level ≥ 30 ng/mL. This outcome is assessed as a binary outcome (yes/no). | Day 21 (± 3 days) after the first dose of study medication |
| Measure | Description | Time Frame |
|---|---|---|
| Event-Free Survival (EFS) | Event-free survival is defined as the time from randomization to the first occurrence of disease progression, relapse after response, initiation of new lymphoma therapy, or death from any cause. | Up to 3 years |
| Progression-Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
Withdrawal Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tanapun Thamgrang, MD | Contact | 66859930142 | tanapun.tham@pcm.ac.th | |
| Napakrit Tanpumiprated, MD | Contact | 66881565102 | napakrich@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Tanapun Thamgrang | Division of Hematology, Department of Medicine, Phramongkutklao Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phramonkutklao Hospital | Bangkok | 10400 | Thailand |
Individual participant data (IPD) will not be shared due to institutional policy and privacy concerns. Only aggregate data may be shared upon reasonable request.
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|
| Standard Weekly Ergocalciferol | Drug | Dose and Schedule:
|
|
Progression-free survival is defined as the time from randomization to the first documented disease progression according to the Lugano 2014 criteria or death from any cause, whichever occurs first. |
| Up to 3 years |
| Overall Survival (OS) | Overall survival is defined as the time from randomization to death from any cause. | Up to 3 years |
| Best Overall Response (BOR) | Best overall response is defined as the best response achieved after completion of first-line immunochemotherapy, including complete response (CR) or partial response (PR), as assessed by PET-CT or CT scan according to the Lugano 2014 criteria. | Through the completion of first-line immunochemotherapy, approximately 24 weeks |
| Change in Serum 25-Hydroxyvitamin D Level | Changes in serum 25-hydroxyvitamin D levels will be compared between study arms and summarized as absolute change and central tendency measures (mean or median). | Day 21 (± 3 days), Day 42 (± 3 days), Day 63 (± 3 days), and Day 126 (± 3 days) (end of treatment) |
| Incidence of Grade ≥ 3 Infections | Incidence of infections graded ≥ 3 according to the Common Terminology Criteria for Adverse Events (CTCAE), version 6.0. | From randomization through 30 days after the last dose of study treatment, approximately 22 weeks |
| Safety and Treatment-Related Toxicity | Safety and toxicity will be assessed based on the incidence of hypercalcemia, hypophosphatemia, and other adverse events, graded according to CTCAE version 6.0. | From randomization through 30 days after the last dose of study treatment, approximately 22 weeks |
| ID | Term |
|---|---|
| C564005 | Vitamin D Hydroxylation-Deficient Rickets, Type 1B |
| D008228 | Lymphoma, Non-Hodgkin |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| 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 |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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