Study of Pirtobrutinib for Patients with Previously Treated Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Non-Hodgkin Lymphoma

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What is this study about?

This clinical trial is focused on studying the effects of a new drug called pirtobrutinib (also known by its code name LY3527727) in patients who have been previously treated for certain types of blood cancers. These cancers include Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), and Non-Hodgkin Lymphoma (NHL). The purpose of the study is to explore the safety and effectiveness of pirtobrutinib when used alone or in combination with other medications.

The study is divided into different phases. In the first phase, patients will receive pirtobrutinib by itself to determine the best dose and to observe any side effects. In the second phase, the study will look at how well the drug works in reducing cancer symptoms. Additionally, there is a part of the study where pirtobrutinib is combined with other drugs like venetoclax and rituximab to see if these combinations are safe and effective. Patients will take the medication in the form of a tablet, which is taken by mouth.

Throughout the study, participants will be monitored for any changes in their health, including blood tests and other assessments to ensure their safety. The study aims to gather information on how the drug affects the body and how it interacts with other treatments. This research is important for developing new treatment options for patients with these types of blood cancers.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, medical history, and current health status.

Participants must have a confirmed diagnosis of certain types of blood cancers, such as chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or non-Hodgkin lymphoma (NHL).

2 phase 1: dose determination

The initial phase involves determining the most suitable dose of the drug pirtobrutinib when taken alone. This is done by gradually increasing the dose to find the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D).

Participants take pirtobrutinib orally in tablet form. The frequency and duration of administration are adjusted based on individual tolerance and response.

3 phase 1b: combination therapy

In this phase, the safety of pirtobrutinib is evaluated when combined with other medications, such as venetoclax or rituximab.

Participants may be assigned to different treatment arms, receiving combinations of these drugs to assess safety and potential interactions.

4 phase 2: assessing effectiveness

The second phase focuses on assessing the effectiveness of pirtobrutinib in treating the specified blood cancers.

Participants continue to take the medication, and their response to treatment is monitored through various assessments, including imaging and blood tests.

5 monitoring and follow-up

Throughout the study, participants undergo regular health checks, including physical exams, blood tests, and other necessary evaluations to monitor their health and the effects of the treatment.

The study is expected to continue until September 2027, with ongoing assessments to ensure participant safety and gather data on the drug’s effectiveness.

Who Can Join the Study?

Must have a confirmed diagnosis of a B-cell cancer, such as Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), or Non-Hodgkin Lymphoma (NHL), and have tried at least two previous treatments or one treatment with a BTK inhibitor if it’s approved as the first treatment.
For Phase 2, the disease must require treatment. For CLL/SLL, treatment needs are defined by specific guidelines. For NHL, there must be at least one area of the disease that can be measured by scans.
Must be at least 18 years old.
Must have a tumor sample available from after the most recent treatment.
Must have adequate blood clotting ability, meaning certain blood tests should not be more than 1.5 times the normal limit.
Must have adequate liver function, with specific liver tests not exceeding certain limits.
Must have adequate kidney function, with a creatinine clearance of at least 30 mL/minute.
Must have adequate blood cell counts, unless the bone marrow is involved in the disease.
Must be able to swallow tablets and attend clinic visits and lab tests as required.
Men and women who can have children must agree to use effective birth control during the study and for a period after the study ends. Sperm donation is not allowed during the study and for a month after.
Must have a performance status of 0 to 2 on a scale that measures daily living abilities, where 0 means fully active and 2 means unable to work but able to care for oneself.

Who Cannot Join the Study?

Patients who have not been previously treated for their condition.
Patients who are currently pregnant or breastfeeding.
Patients with a history of severe allergic reactions to similar medications.
Patients with other active cancers that require treatment.
Patients with severe heart problems.
Patients with uncontrolled infections.
Patients who have had a major surgery within the last 4 weeks.
Patients with a history of drug or alcohol abuse.
Patients who are unable to swallow pills.
Patients with certain blood disorders.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Instytut Hematologii I Transfuzjologii	Warsaw	Poland
Ospedale San Raffaele S.r.l.	Milan	Italy
Pratia S.A.	Skorzewo	Poland
Centre Hospitalier Universitaire De Nantes	Nantes	France
Azmkdmt Ujssg Snpgsoloq Lcoovc Ds Bzecpro	Bologna	Italy

Trial status

Country	Status	Recruitment Start
France	Not recruiting	14.10.2019
Italy	Not recruiting	14.10.2019
Poland	Not recruiting	14.10.2019

Trial locations

Investigated drugs:

Pirtobrutinib

Pirtobrutinib is an oral medication being studied for its effects on patients with previously treated chronic lymphocytic leukemia, small lymphocytic lymphoma, or non-Hodgkin lymphoma. The trial aims to determine the maximum tolerated dose and assess its antitumor activity.

Venetoclax is a medication used in combination with pirtobrutinib in this study. It is designed to help kill cancer cells by targeting a specific protein that helps them survive.

Rituximab is another medication used in combination with pirtobrutinib and venetoclax in this trial. It is a type of therapy that targets certain cells in the immune system to help fight cancer.

Investigated diseases:

Chronic Lymphocytic Leukemia (CLL) – This is a type of cancer that affects the blood and bone marrow, characterized by the production of too many abnormal lymphocytes, a type of white blood cell. It progresses slowly and may not cause symptoms for years. Over time, these abnormal cells can crowd out healthy blood cells, leading to issues like anemia, infections, and bleeding problems. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen.

Small Lymphocytic Lymphoma (SLL) – SLL is a type of non-Hodgkin lymphoma that primarily affects the lymph nodes. It is closely related to CLL, with the main difference being the location of the cancer cells. In SLL, the cancer cells are mainly found in the lymph nodes, whereas in CLL, they are primarily in the blood and bone marrow. The disease progresses slowly and may not cause symptoms initially, but over time, it can lead to swollen lymph nodes, fatigue, and other systemic symptoms.

Non-Hodgkin Lymphoma (NHL) – This is a diverse group of blood cancers that include any kind of lymphoma except Hodgkin’s lymphomas. NHL can occur at any age and often starts in the lymph nodes, but it can also affect other organs. The progression of NHL varies widely depending on the specific type and can range from slow-growing to aggressive forms. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss.

Trial ID:

2023-509270-37-00

Protocol code:

LOXO-BTK-18001 BRUIN

NCT ID:

NCT03740529

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study of Pirtobrutinib for Patients with Previously Treated Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Non-Hodgkin Lymphoma

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