Not recruitingRare disease

Study of Loncastuximab Tesirine and Rituximab for Untreated Unfit or Frail Patients with Diffuse Large B-cell Lymphoma

Fast replyRegistered drugNo placebo

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What is this trial about?

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

This clinical trial is focused on studying a type of cancer called Diffuse Large B-cell Lymphoma (DLBCL), which is a common form of non-Hodgkin lymphoma. The study is exploring the effectiveness of a treatment combination involving two medications: Loncastuximab Tesirine and Rituximab. Loncastuximab Tesirine, also known by its code name ADCT-402, is a type of medication called a monoclonal antibody, which is designed to target and destroy cancer cells. Rituximab is another monoclonal antibody that is commonly used to treat certain types of lymphoma.

The purpose of this study is to evaluate how well this combination treatment works in patients who have not been treated before and are considered unfit or frail due to age or other health conditions. The study will involve two groups of patients. One group will include those who are unfit, and the other will include those who are frail or have heart-related health issues. The treatment will be given through an infusion, which means the medication is delivered directly into the bloodstream through a vein.

Participants in the study will receive the treatment over a period of time, and their response to the treatment will be monitored. The study aims to understand how well the treatment works and how well patients tolerate it. The trial will also look at the safety of the treatment and any side effects that may occur. The study is expected to continue for several years to gather comprehensive data on the treatment's effectiveness and safety.

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
Joining the study
Upon joining the study, you will be informed about the trial's purpose and procedures. You will be asked to provide consent to participate in the study.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes a review of your medical history and a physical examination.
Laboratory tests will be performed to ensure your organ functions are adequate. These tests include blood tests to check your blood cell counts and liver function.
Step 3
Treatment phase
You will receive the study medications, loncastuximab tesirine and rituximab, through an intravenous infusion. This means the medication will be administered directly into your vein.
The dosage and frequency of the medications will be determined by the study protocol. You will be informed about the schedule and duration of each treatment cycle.
Step 4
Monitoring and follow-up
Throughout the study, regular monitoring will be conducted to assess your response to the treatment. This includes physical examinations, blood tests, and imaging studies.
You will be asked to report any side effects or changes in your health. The study team will provide guidance on managing any adverse effects.
Step 5
End of treatment
At the end of the treatment phase, a final assessment will be conducted to evaluate the overall response to the study medications.
You will be informed about the results and any further steps, if necessary.

Who can join the trial?

13 criteria

Must be male or female.
Must have a confirmed diagnosis of Diffuse Large B-cell Lymphoma (DLBCL), High-Grade B-cell Lymphoma (HGBCL), or Grade 3b Follicular Lymphoma (FL).
Must have a measurable disease, which means the disease can be measured by medical tests.
Must be in Stages I-IV of the disease, which refers to the extent or severity of the disease.
Must have an ECOG Performance Status of 0-2. This is a scale used to assess how the disease affects daily living abilities. A score of 3 is allowed if the decline is due to lymphoma and can be improved by treatment.
Must have adequate organ function based on specific blood test results:
- Absolute neutrophil count (a type of white blood cell) of at least 1.0 x 10^3/µL.
- Platelet count of at least 75 x 10^3/µL without recent transfusion.
- Liver enzymes (ALT, AST, GGT) should be no more than 2.5 times the normal limit.
- Total bilirubin should be no more than 1.5 times the normal limit, except for certain conditions.
- Creatinine clearance (a measure of kidney function) should be more than 30 mL/min.
- Women of childbearing potential must use effective birth control during the study and for 12 months after the last treatment. Men must use a condom or practice abstinence during the study and for 7 months after the last treatment.
- For Cohort A:
  - Must be considered unfit based on specific criteria, including being 80 years or older and meeting certain scores on daily living activities and health assessments.
  - For Cohort B:
    
    Must be considered frail based on specific criteria, including being 80 years or older with certain scores on daily living activities and health assessments, or being 65-79 years old with specific heart conditions that make certain treatments unsuitable.

Who cannot join the trial?

7 criteria

Patients who have already received treatment for their lymphoma.
Patients who are not considered unfit or frail. Unfit means not in good health, and frail means weak or delicate.
Patients who do not have cardiac comorbidities. This means they do not have other heart-related health issues.
Patients who are eligible for standard treatment called R-mini-CHOP. This is a common treatment for certain types of lymphoma.
Patients who are not part of the specified age range for the study.
Patients who do not meet the gender requirements for the study.
Patients who are not considered part of a vulnerable population. This means they are not in a group that needs special protection or care.

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Verified sites

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

Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
Verified
Alexandria, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Verified
Milan, Italy
Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy

Trial locations

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Investigated drugs

Loncastuximab Tesirine
is a type of medication known as an antibody-drug conjugate. It is designed to target and attach to specific cancer cells, particularly those found in certain types of lymphoma. Once attached, it delivers a small dose of chemotherapy directly to the cancer cells, which helps to kill them while minimizing damage to healthy cells. This targeted approach aims to reduce side effects compared to traditional chemotherapy.
Rituximab
is a medication that is used to treat certain types of cancer, including lymphoma. It works by targeting a specific protein found on the surface of cancer cells, which helps the body's immune system to recognize and destroy these cells. Rituximab is often used in combination with other cancer treatments to improve their effectiveness.

What is already known about the treatment

Loncastuximab Tesirine
This medication is administered through an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating diffuse large B-cell lymphoma, a type of blood cancer. The main therapeutic use of Loncastuximab Tesirine is to target and destroy cancer cells. At the molecular level, it works by binding to a specific protein on the surface of cancer cells, delivering a toxic substance that kills these cells. It is classified as an antibody-drug conjugate, which is a type of targeted cancer therapy.
Rituximab
This medication is also administered via intravenous infusion. It is well-established in medical practice and literature for treating various types of blood cancers, including diffuse large B-cell lymphoma. Rituximab works by targeting a protein called CD20 found on the surface of certain cancer cells, leading to their destruction by the immune system. It is classified as a monoclonal antibody, which is a type of targeted therapy that helps the immune system fight cancer.

Investigated diseases

Diffuse Large B-Cell Lymphoma – Diffuse Large B-Cell Lymphoma (DLBCL) 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, bone marrow, or other organs. The disease often begins with a painless swelling in the neck, armpit, or groin due to enlarged lymph nodes. As it progresses, it can spread to other parts of the body, including the central nervous system. Symptoms may include fever, night sweats, and weight loss. The progression of DLBCL can vary, with some cases advancing quickly while others may develop more slowly.