RecruitingRare disease

A study to evaluate the effectiveness of pirtobrutinib in elderly and frail patients with mantle cell lymphoma who have not yet received treatment.

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This study focuses on Mantle Cell Lymphoma, a type of blood cancer that affects the lymphatic system. The research is being conducted to evaluate how well a medication called pirtobrutinib works as a first-line treatment for older patients who are considered frail or unfit for more intense therapies. The treatment involves taking the drug by mouth.

Participants in the study will receive pirtobrutinib as a single medication. The goal is to determine how long the disease remains stable without getting worse, which is known as progression-free survival. This term refers to the length of time from the start of the medication until the cancer begins to grow again or the patient passes away from any cause.

During the study, the effectiveness of the drug will be monitored by looking at how much the cancer shrinks or disappears, which is called the overall response rate. Researchers will also track how long patients live and how the treatment impacts their daily quality of life. Any side effects or issues that cause a person to stop taking the medication will also be recorded.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Treatment initiation
The treatment with pirtobrutinib begins. this is a medication taken by mouth.
The dosage is 200 mg.
Step 2
Monitoring for efficacy and safety
The progress of the mantle cell lymphoma, which is a type of blood cancer, is monitored to see how the body responds to the medication.
The time until the disease potentially grows again or worsens is tracked, a measurement known as progression free survival.
Side effects, which are adverse events, are monitored to assess how well the body tolerates the treatment.
Health-related quality of life is measured through standardized questionnaires to understand how the treatment affects daily well-being.

Who can join the trial?

19 criteria

A confirmed diagnosis of mantle cell lymphoma (MCL), which is a type of blood cancer, through a tissue sample examination.
The patient must provide written informed consent, which means signing a document that shows they understand and agree to take part in the study.
Men must use highly effective contraception (methods to prevent pregnancy) during the study and for at least 3 months after the last dose.
Availability of biopsy material, which is a small sample of tissue, for a specialist to review and to look for specific mutations (changes in DNA) like the TP53 gene.
The patient must be 70 years of age or older.
The mantle cell lymphoma must be untreated, meaning the patient has not received therapy for this specific cancer before.
The disease must be active and in need of treatment according to standard medical practices.
The patient must be ineligible for standard full-dose chemotherapy treatments.
The patient must be classified as frail or unfit based on specific medical assessments of their daily living abilities and existing health conditions.
The cancer must be at Ann Arbor Stage I - IV, which is a system used to describe how much the cancer has spread in the body.
There must be at least one measurable lesion (an area of cancer) that is larger than 1.5 cm when viewed on a CT scan (a special type of X-ray image).
The patient must have an ECOG performance status of 0 to 2, which is a scale used to measure how well a person can perform daily activities and their overall physical health.
The patient must have adequate hematologic function, meaning their blood counts must be within safe levels, including hemoglobin (which carries oxygen), white blood cells (which fight infection), and platelets (which help blood clot).
The patient must have adequate renal function, meaning their kidneys (the organs that filter waste from the blood) are working well, measured by creatinine clearance or serum creatinine levels.
The patient must have adequate coagulation, which means their blood is able to clot properly, measured by tests called aPTT, PTT, PT, or INR.
The patient must have adequate hepatic function, meaning their liver is working correctly, measured by levels of ALT, AST, and bilirubin.
The patient must be able and willing to follow all the steps and rules of the study protocol (the official plan for the research).
The patient must have a life expectancy of more than 6 months.
The patient must be able to swallow and take oral medications (pills or liquids taken by mouth).

Who cannot join the trial?

29 criteria

You are a candidate for watch and wait, which means your doctor suggests monitoring the disease without immediate treatment because it is indolent (slow-growing).
You have a history of severe bleeding diathesis, which is a condition where you are at a high risk of heavy or uncontrollable bleeding.
You have an active herpes zoster (shingles) infection, unless you are currently taking Valacyclovir to treat it.
You are considered fit according to medical scales, meaning you are healthy enough to receive a full dose of standard chemotherapy.
You have leukemic non-nodal MCL that is currently stable and not causing any symptoms.
Your medical diagnosis is something other than Mantle Cell Lymphoma (MCL) or leukemic non-nodal MCL.
You have an active, uncontrolled auto-immune cytopenia, which means your immune system is attacking and lowering your blood cell counts (such as autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura), and you have recently changed your medication for this.
You have significant cardiovascular disease (heart problems), such as unstable angina (chest pain), a recent myocardial infarction (heart attack), a low left ventricular ejection fraction (a measurement of how well your heart pumps blood), severe heart failure, or uncontrolled arrhythmias (irregular heartbeats).
You have a prolongation of the QT interval, which is a specific measurement of the time it takes for your heart muscle to recharge between beats, if it is longer than 470 msec.
You have any other medical or mental health condition that would prevent you from safely participating or from giving informed consent (giving legal permission to join the study).
You are eligible for or are a candidate for intensive chemotherapy treatments such as BR, R-CHOP, VR-CAP, or RBAC500.
You test positive for the Hepatitis C virus (HCV), unless your HCV-RNA (the actual virus in your blood) test is negative.
There is evidence that the lymphoma has spread to the CNS (central nervous system, which includes the brain and spinal cord).
You have a contraindication (a medical reason why a specific treatment should not be used) to using BTKi (a type of targeted drug used for lymphoma).
You test positive for HBsAg (a marker for Hepatitis B), unless you have a negative HBV-DNA test and are taking preventative antiviral medicine.
You have had a stroke or intracranial hemorrhage (bleeding inside the skull) within the last 6 months.
You have had CAR-T therapy (a type of immune cell treatment) within the last 60 days, or you have ongoing issues like graft versus host disease (GVHD), low blood counts, or high levels of steroid use.
You have any evidence of a severe, active infection, whether it is acute (sudden) or chronic (long-lasting).
You do not have a caregiver (someone to help you) if you are unable to perform daily tasks independently.
You need to take anticoagulation medicine like warfarin (blood thinners) to prevent clots.
You have received a live vaccine within the last 28 days.
You have a known hypersensitivity (allergic reaction) to any of the ingredients in Pirtobrutinib or other study medicines.
You have an active cytomegalovirus (CMV) infection.
You are positive for HIV.
You have a significant malabsorption syndrome, which means your body cannot properly absorb nutrients or medicines through your gastrointestinal (GI) tract (stomach and intestines).
You have any other uncontrolled medical condition, such as a systemic infection, that could make participating in the study risky.
You have had major surgery within the last 4 weeks.
You have a history of other malignancies (cancers) unless they are currently in remission (showing no signs of cancer) and you are expected to live longer than 2 years.
You have experienced a Grade 3 arrhythmia, which is a severe irregular heartbeat.

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Verified sites

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

Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Responsive
Palermo, Italy
Azienda Ospedaliera Universitaria Senese
Responsive
Siena, Italy
Azienda Ospedaliero Universitaria Parma
Responsive
Parma, Italy

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Investigated drugs

Pirtobrutinib is a medication taken by mouth that is being studied to see how well it works as a first-line treatment for elderly or frail patients who have mantle cell lymphoma, a type of blood cancer.

Pirtobrutinib

What is already known about the treatment

Pirtobrutinib - This medication is taken by mouth as a pill and is currently being studied in clinical trials to see how well it works as a first-line treatment for certain blood cancers. It belongs to a group of drugs called Bruton's tyrosine kinase (BTK) inhibitors, which work by blocking a specific protein that cancer cells need to grow and survive. This drug is being investigated for patients with mantle cell lymphoma, a type of non-Hodgkin lymphoma, especially those who are older or more fragile.

Investigated diseases

Mantle Cell Lymphoma - This is a type of cancer that begins in the white blood cells known as B cells. It occurs when these cells undergo a genetic change that causes them to grow uncontrollably within the lymphatic system. The disease typically develops in the lymph nodes, but it can also affect other parts of the body like the spleen or bone marrow. As it progresses, the abnormal cells multiply and can spread throughout the body. This accumulation of cells may lead to swelling in various organs and tissues.