Not recruitingRare disease

Study of Lorlatinib for Patients with ALK+ Anaplastic Large Cell Lymphoma After Ineffective ALK Inhibitor Treatment

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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 known as Anaplastic Large Cell Lymphoma (ALCL) that expresses a protein called ALK. This study is specifically for patients whose lymphoma has returned or has not responded to previous treatments with medications known as ALK inhibitors. The treatment being tested in this trial is a drug called lorlatinib, which is also known by its code name PF-06463922. Lorlatinib is taken orally in the form of film-coated tablets.

The purpose of the study is to understand how well lorlatinib works in patients with ALK-positive lymphoma who have not had success with other ALK inhibitor treatments. Participants in the study will take lorlatinib tablets and will be monitored over a period of time to see how their lymphoma responds to the treatment. The study will also look at other aspects such as the progression of the disease, overall survival, any side effects experienced, and the quality of life of the participants.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the effects of the treatment. The study aims to provide valuable information on the effectiveness of lorlatinib for patients with this specific type of lymphoma, potentially offering a new treatment option for those who have not benefited from existing therapies.

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
Initiation of treatment
The treatment begins with the administration of lorlatinib, which is the active substance in the medication Lorviqua.
The medication is provided in the form of 25 mg film-coated tablets.
The tablets are taken orally, meaning they are swallowed with water.
Step 2
Dosage and frequency
The specific dosage and frequency of the medication will be determined by the healthcare provider based on individual patient needs and response to treatment.
It is important to follow the prescribed schedule for taking the medication to ensure its effectiveness.
Step 3
Monitoring and assessments
Regular visits to the healthcare provider are necessary to monitor the response to the treatment.
These visits may include physical examinations, blood tests, and imaging studies such as CT or CT-PET scans to assess the presence of measurable disease.
Step 4
Duration of treatment
The duration of the treatment will depend on the patient's response and any side effects experienced.
The healthcare provider will provide guidance on how long the treatment should continue.
Step 5
Evaluation of treatment response
The primary goal is to determine the objective response rates (ORR) to the treatment.
Secondary evaluations may include progression-free survival (PFS), overall survival (OS), toxicity, quality of life (QoL), and mutational analysis.

Who can join the trial?

11 criteria

You must sign and date an Informed Consent form, which is approved by a Local Ethical Committee, before any specific screening procedures for the study.
You should be willing and able to attend scheduled visits, follow treatment plans, and undergo laboratory tests and other study procedures.
If you are a female or male who can have children, you must agree to use two effective forms of contraception with your partner during the study and for at least 90 days after the last dose of treatment.
You must have a diagnosis of ALK+ Lymphoma, which is a type of cancer, confirmed by specific tests called IHC or FISH.
Your disease must be refractory (not responding to treatment) or have relapsed after at least one prior chemotherapy regimen and at least one ALK inhibitor. You must have measurable disease, which means it can be seen or measured by a doctor using physical examination, CT, or CT-PET scan.
Any previous cancer treatment or major surgeries must have been completed at least 14 days before starting the study medication, unless there is clear evidence of disease progression, such as growing pain, fever, or increasing tumor size.
You must be able to take oral therapy, which means you can swallow pills or liquid medicine.
You must be 18 years of age or older.
Your ECOG performance status, which measures your ability to perform daily activities, must be between 0 and 3.
You must have adequate organ function, which includes specific levels of liver enzymes (AST and ALT), bilirubin, and creatinine in your blood.
You must have adequate bone marrow function, which includes specific levels of neutrophils, platelets, and hemoglobin in your blood. These values may not be considered if your bone marrow is involved in the disease.

Who cannot join the trial?

4 criteria

Patients who have a different type of cancer than Anaplastic Large Cells Lymphoma (ALCL) ALK+ cannot participate.
Patients who are not resistant or do not have a cancer that does not respond to ALK inhibitors cannot participate. ALK inhibitors are medicines used to treat certain types of cancer.
Patients who are younger than 18 years old cannot participate.
Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, cannot participate.

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Verified sites

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Fondazione IRCCS San Gerardo Dei Tintori
Monza, Italy

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Investigated drugs

Lorlatinib: This is a medication used in the study to treat patients with a specific type of lymphoma that is positive for ALK (anaplastic lymphoma kinase). It is given to patients who have already been treated with other ALK inhibitors but have not responded well or have relapsed. Lorlatinib works by targeting and blocking the activity of the ALK protein, which can help slow down or stop the growth of cancer cells.

Lorlatinib

What is already known about the treatment

Lorlatinib – Lorlatinib is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating patients with relapsed ALK-positive lymphoma, specifically Anaplastic Large Cells Lymphoma (ALCL) ALK+. The medication works by inhibiting the activity of the ALK protein, which is involved in the growth and spread of cancer cells. Lorlatinib is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

Investigated diseases

Anaplastic Large Cell Lymphoma (ALCL) ALK+ – This is a type of non-Hodgkin lymphoma characterized by the presence of large, abnormal lymphocytes. It is associated with a genetic alteration involving the ALK gene, which can lead to uncontrolled cell growth. The disease often presents with symptoms such as swollen lymph nodes, fever, and weight loss. It can affect various parts of the body, including lymph nodes, skin, and organs. ALCL ALK+ is known for its aggressive nature, but it can vary in how quickly it progresses. The condition is considered rare and requires specialized medical attention.