Not recruiting

Study on Prednisone and Vitamin D for Elderly Patients with Diffuse Large B-Cell Lymphoma

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for elderly patients with a type of cancer called Diffuse Large B-Cell Lymphoma (DLBCL) and another type called Follicular Lymphoma grade IIIb (FL3B). The study will use a medication called prednisone, which is a synthetic glucocorticoid, and may also include a supplement known as Vitamin D (also referred to as colecalciferol). The purpose of the study is to see if adding Vitamin D to the treatment with prednisone can improve the time patients live without the disease getting worse, known as progression-free survival.

Participants in the study will receive a pre-treatment phase with oral prednisone, with some also receiving Vitamin D supplementation. This will be followed by six cycles of a standard cancer treatment called immunochemotherapy. The study is designed to compare the outcomes of those who receive Vitamin D with those who do not, to determine if the addition of Vitamin D provides any benefits in managing the disease.

The trial is open-label, meaning both the researchers and participants know which treatments are being administered. It is a randomized study, so participants will be randomly assigned to either receive Vitamin D with prednisone or prednisone alone. The study aims to provide valuable information on whether Vitamin D can enhance the effectiveness of the treatment for elderly patients with DLBCL and FL3B.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Prephase treatment
The initial stage involves a prephase treatment. This includes taking oral prednisone and possibly Vitamin D supplementation. The purpose is to prepare the body for the main treatment phase.
Prednisone is a medication that helps reduce inflammation and suppresses the immune system. Vitamin D is a supplement that may be added to support bone health and immune function.
Step 2
Randomization
Participants are randomly assigned to one of two groups. One group receives only prednisone, while the other group receives both prednisone and Vitamin D. This process is called randomization and ensures that the study results are unbiased.
Step 3
Immunochemotherapy cycles
Following the prephase treatment, participants undergo 6 cycles of immunochemotherapy. This is a combination of chemotherapy and immunotherapy designed to target and destroy cancer cells.
The specific regimen used is either R-CHOP or R-miniCHOP, which are standard treatments for Diffuse Large B-Cell Lymphoma (DLBCL).
Step 4
Monitoring and assessments
Throughout the trial, regular monitoring and assessments are conducted to evaluate the effectiveness of the treatment and to check for any side effects.
These assessments include blood tests, imaging scans, and physical examinations to track the progression of the disease and the patient's response to treatment.
Step 5
End of treatment evaluation
At the end of the treatment cycles, a comprehensive evaluation is performed to determine the overall response to the therapy.
This includes measuring progression-free survival, overall survival, and other health outcomes to assess the success of the treatment.

Who can join the trial?

17 criteria

Must have a confirmed diagnosis of **Diffuse Large B-cell Lymphoma** or **Follicular grade IIIb lymphoma**.
Must have adequate blood counts, which means enough healthy blood cells unless affected by lymphoma.
Must have proper kidney function, with a creatinine level of 2 mg/dL or less unless affected by lymphoma.
Must have proper liver function, with a bilirubin level of 2 mg/dL or less unless affected by lymphoma.
Must have a heart function with an **LVEF** (Left Ventricular Ejection Fraction) greater than 40%.
Must have a life expectancy of at least 6 months.
Must understand and sign a consent form before starting any study procedures.
Must be able to follow the study visit schedule and other study requirements.
Men must agree to use effective birth control methods during the study and for 3 months after the last treatment dose, and not donate sperm during the study.
Must be 65 years of age or older.
Must have a **Simplified Geriatric Assessment** done before starting any treatment.
Must have an **ECOG performance status** of 3 or less, which measures daily living abilities.
Must be eligible for a 6-cycle treatment with a specific chemotherapy regimen (R-CHOP or R-miniCHOP).
Must not have had any previous treatment for DLBCL or Follicular grade IIIb lymphoma.
Must be in **Ann Arbor stage I-IV**, which describes the extent of lymphoma.
Must have at least one measurable site of disease, either through a CT scan or a PET scan.
Must have a baseline **Vitamin D** level of 40 ng/ml or less.

Who cannot join the trial?

5 criteria

Patients who are not diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL) or Follicular lymphoma grade IIIb (FL3B).
Patients who are not considered elderly.
Patients who cannot take oral medications like prednisone or Vitamin D.
Patients who have other serious health conditions that might interfere with the study.
Patients who are part of a vulnerable population, meaning they might not be able to give informed consent or understand the study.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliera Universitaria Senese
Responsive
Siena, Italy
Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
Azienda Ospedaliero-Universitaria Sant Andre
Responsive
Rome, Italy

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Prednisone
is a medication used to reduce inflammation and suppress the immune system. In this trial, it is used as a prephase treatment for elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma grade IIIb (FL3B).
Vitamin D
is a supplement that helps maintain healthy bones and supports the immune system. In this study, it is given alongside prednisone to see if it improves the effectiveness of the prephase treatment for patients with DLBCL and FL3B.
Immunochemotherapy
is a combination of chemotherapy and immunotherapy used to treat cancer. In this trial, it follows the prephase treatment and consists of 6 cycles aimed at treating elderly patients with DLBCL and FL3B.

What is already known about the treatment

Prednisone
Prednisone is administered orally and is commonly used in the treatment of various inflammatory and autoimmune conditions. In the context of this clinical trial, it is being evaluated for its effectiveness in elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL) when used as a prephase therapy. Prednisone is a corticosteroid that works by suppressing the immune system and reducing inflammation. It is well-established in medical literature and is classified as a glucocorticoid.
Vitamin D
Vitamin D is administered orally and is being studied in this trial for its potential benefits when combined with prednisone in elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL). It is known for its role in bone health and immune function. The trial aims to assess whether Vitamin D supplementation can improve progression-free survival when added to the prephase therapy. Vitamin D is classified as a vitamin and is widely recognized in medical literature for its various health benefits.

Investigated diseases

Diffuse Large B-Cell Lymphoma (DLBCL)
This is a type of non-Hodgkin lymphoma that originates in the B-cells, which are a type of white blood cell. It is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, or other organs. The disease can start in any part of the body and may spread to other areas. Symptoms often include swollen lymph nodes, fever, night sweats, and weight loss. DLBCL is the most common form of non-Hodgkin lymphoma and can occur in individuals of any age, though it is more prevalent in older adults. The progression of the disease can vary, with some cases advancing quickly while others may develop more slowly.
Follicular Lymphoma Grade IIIb (FL3B)
This is a subtype of follicular lymphoma, which is a type of non-Hodgkin lymphoma. It is characterized by the presence of large, abnormal B-cells in the lymph nodes. FL3B is considered more aggressive than other grades of follicular lymphoma, with a tendency to grow and spread more rapidly. Patients may experience symptoms such as enlarged lymph nodes, fatigue, fever, and weight loss. The disease can affect various parts of the body, including the bone marrow and spleen. FL3B is typically diagnosed in older adults and requires careful monitoring due to its potential for progression.