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New treatment option for Diffuse Large B-Cell Lymphoma
Official title Prephase Treatment With Prednisone +/- Vitamin D Supplementation Followed by Immunochemotherapy
ClinicalTrials.gov ID: NCT04442412
What this study is testing
What is Vitamin D3 (Cholecalciferol)?
Vitamin D3 (Cholecalciferol) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for diffuse large b-cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label, multicenter, randomized phase III trial. The study plans to randomize patients with a 1 to 1 ratio to Arm A (Standard arm) or Arm B (Experimental arm).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- Histologically documented diagnosis of Diffuse Large B-cell Lymphoma or Follicular grade IIIb lymphoma, as defined in the 2017 edition of the World...
- Age ≥ 65 years
- Comprehensive Geriatric Assessment performed at baseline, before start of any treatment.
- Eastern Cooperative Oncology Group performance status (PS) ≤3
- Eligibility for anthracycline containing regimen (R-CHOP or R-miniCHOP)
You likely can't join if
- Histological diagnosis different from Diffuse large B-Cell Lymphoma or Follicular grade IIIb lymphoma, including diagnosis of HGBL, with...
- Use of VitD supplementation as standard of care at dose higher than 10,000 U/week
- Suspect or clinical evidence of CNS involvement by lymphoma
- Contraindication to the use of rituximab
- Contraindication to the use of VitD supplementation (Hypercalcemia/Hyperphosphatemia)
- Subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, investigational therapy, including targeted small...
See the full eligibility criteria
- Histologically documented diagnosis of Diffuse Large B-cell Lymphoma or Follicular grade IIIb lymphoma, as defined in the 2017 edition of the World Health Organization (WHO) classification.
- Age ≥ 65 years
- Comprehensive Geriatric Assessment performed at baseline, before start of any treatment.
- Eastern Cooperative Oncology Group performance status (PS) ≤3
- Eligibility for anthracycline containing regimen (R-CHOP or R-miniCHOP)
- No previous treatment for DLBCL or Follicular grade IIIb lymphoma
- Ann Arbor stage I-IV
- At least one site of measurable nodal disease at baseline ≥ 1.5 cm in the longest transverse diameter as determined by CT scan ; or one metabolic active site of disease at baseline FDG-PET scan
- Serum basic levels of Vitamin D [25 (OH) VitD] ≤ 40 ng / ml;
- Adequate hematological counts defined as follows:
- Absolute Neutrophil count \> 1.5 x 109/L unless due to bone marrow involvement by lymphoma
- Platelet count ≥ 80.000/mm3 unless due to bone marrow involvement by lymphoma
- Adequate renal function defined as follows: \- Creatinine ≤ 2 mg/dL, unless secondary to lymphoma
- Adequate hepatic function defined as follows: \- Bilirubin ≤ 2 mg/dL unless secondary to lymphoma
- LVEF \> 50% at bidimensionally echocardiogram
- Life expectancy ≥ 6 months
- Subject understands and voluntarily signs an informed consent form approved by an Independent Ethics Committee , prior to the initiation of any screening or study-specific procedures
- Subject must be able to adhere to the study visit schedule and other protocol requirements
- Men must agree to use one of the below reported acceptable method of contraception for the duration of the study and for 3 months after receiving the last dose of immunochemotherapy, and to not donate sperm while on...
- Histological diagnosis different from Diffuse large B-Cell Lymphoma or Follicular grade IIIb lymphoma, including diagnosis of HGBL, with rearrangement of MYC, BCL2 and/or BCL6 (double-hit)
- Use of VitD supplementation as standard of care at dose higher than 10,000 U/week
- Suspect or clinical evidence of CNS involvement by lymphoma
- Contraindication to the use of rituximab
- Contraindication to the use of VitD supplementation (Hypercalcemia/Hyperphosphatemia)
- Subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, investigational therapy, including targeted small molecule agents within 14 days prior to the first dose of study drug
- Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent
- Any history of other active malignancies within 2 years prior to study entry, with the exception of adequately treated in situ carcinoma of the cervix uterine, basal cell carcinoma of the skin or localized squamous cell...
- Evidence of other clinically significant uncontrolled condition including, but not limited to:
- Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
- Chronic hepatitis B virus or hepatitis C requiring treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Brescia, BS, Italy
- Piacenza, PC, Italy
- Rionero in Vulture, Piacenza, Italy
- Alessandria, Italy
- Ancona, Italy
- Ascoli Piceno, Italy
- Aviano, Italy
- Barletta, Italy
- Bergamo, Italy
- Biella, Italy
- Campobasso, Italy
- Castelfranco Veneto, Italy
- Florence, Italy
- Frosinone, Italy
- Matera, Italy
- Meldola, Italy
- Mestre, Italy
- Milan, Italy
- Monza, Italy
- Naples, Italy
+ 21 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brescia, BS, Italy; Piacenza, PC, Italy; Rionero in Vulture, Piacenza, Italy; Alessandria, Italy; Ancona, Italy; Ascoli Piceno, Italy and 35 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.