Study Comparing Pirtobrutinib and Ibrutinib for Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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What is this study about?

This clinical trial is focused on studying two treatments for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL). These are types of cancer that affect the blood and lymph nodes. The study compares two medications: Pirtobrutinib (also known by its code name LOXO-305) and Ibrutinib. Both medications are taken orally, with Pirtobrutinib in tablet form and Ibrutinib in capsule form.

The purpose of the study is to evaluate how well patients respond to Pirtobrutinib compared to Ibrutinib. Participants in the study will be randomly assigned to receive either Pirtobrutinib or Ibrutinib. The study will monitor the overall response rate, which means it will look at how many patients experience a reduction in their cancer symptoms or achieve remission, where the cancer is no longer detectable. The study is expected to last for a period of up to 66 weeks.

Throughout the study, participants will be closely monitored by healthcare professionals to ensure their safety and to assess the effectiveness of the treatment. The study aims to provide valuable information on which medication might be more effective for treating CLL and SLL, potentially leading to improved treatment options for patients with these conditions.

1 joining the study

Upon joining the study, the patient is assigned to one of two groups: Arm A or Arm B.

Arm A receives pirtobrutinib, and Arm B receives ibrutinib.

2 medication administration

Both pirtobrutinib and ibrutinib are taken orally.

The specific dosage and frequency of administration are determined by the study protocol and communicated to the patient by the healthcare team.

3 treatment duration

The treatment continues until the study’s estimated end date, which is May 1, 2028, unless otherwise specified by the healthcare team.

4 monitoring and assessments

Regular monitoring and assessments are conducted to evaluate the patient’s response to the treatment.

The primary goal is to assess the overall response rate, which includes complete remission and partial response.

5 completion of the study

Upon completion of the study, the patient’s overall response to the treatment is reviewed.

Further instructions or follow-up care may be provided based on the patient’s condition and response to the treatment.

Who Can Join the Study?

Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) that requires treatment according to specific medical guidelines.
Must have an ECOG Performance Status of 0 to 2, which is a scale used to assess how well a person can perform daily activities. A score of 0 means fully active, while 2 means capable of all self-care but unable to carry out any work activities.
Must have adequate organ function, which includes:

Platelet count of at least 50,000 per microliter of blood, or at least 30,000 if the bone marrow is affected by the disease.
Hemoglobin level of at least 8 grams per deciliter, or at least 6 grams if the bone marrow is affected by the disease. Hemoglobin is a protein in red blood cells that carries oxygen.
Absolute neutrophil count of at least 0.75 billion per liter, or at least 0.50 billion if the bone marrow is affected by the disease. Neutrophils are a type of white blood cell important for fighting infections.
Kidney function with an estimated creatinine clearance of at least 30 milliliters per minute. Creatinine clearance is a measure of how well the kidneys are working.

Both male and female participants are eligible.
Participants from vulnerable populations are eligible.

Who Cannot Join the Study?

Patients who have a different type of cancer than Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not part of the specified clinical trial group cannot participate.
Patients who are not male or female cannot participate.
Patients who are considered part of a vulnerable population cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario De Navarra	Pamplona	Spain
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Gemeinschaftspraxis Haematologie Onkologie	Dresden	Germany

Other Sites

Site Name	City	Country
Centre Hospitalier Departemental Vendee	La Roche sur Yon	France
Centre Antoine Lacassagne	Nice	France
Hopitaux Universitaires Pitie Salpetriere	Paris	France
University Of Debrecen	Debrecen	Hungary
University Hospital Ostrava	Ostrava	Czechia
Virgen del Rocío University Hospital	Sevilla	Spain
Ospedale San Raffaele S.r.l.	Milan	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Fakultni Nemocnice Brno	Brno	Czechia
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse	Vienna	Austria
Centre Hospitalier Universitaire De Nantes	Nantes	France
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Centre Hospitalier Universitaire De Rennes	Rennes	France
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Vitaz	Sint-Niklaas	Belgium
Fakultni Nemocnice Plzen	Plzen	Czechia
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Poland
Centre Henri Becquerel	Rouen	France
Pratia Hematologia Sp. z o.o.	Katowice	Poland
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej	Biala Podlaska	Poland
University Teaching Hospital Markusovszky	Szombathely	Hungary
Centre Hospitalier Le Mans	Le Mans	France
Pratia S.A.	Skorzewo	Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie	Lublin	Poland
Hospital Universitario Infanta Leonor	Madrid	Spain
Hospital Costa del Sol	Marbella	Spain
Hjcsgzda Vqfj dswbatuo	Barcelona	Spain
Itquclxy Rmyymgmer Pnt Li Sfyvdu Dng Twxwvb Dnls Aspyhlb Imfh Syncnp	Meldola	Italy
Cjchjr Hmghcmlejxa Rcidxpbe Uakpwoqpmccdk Dk Tqfgr	Tours	France
Avukwqf Ueejx Shqyjcaif Lgdgvn Dm Bcphejm	Bologna	Italy
Udqcondkyzxwqn Cxxyjyv Kjzyigwzd	Gdansk	Poland
Hzhbjqrv Dn Li Szswa Cnwa I Sygg Pvz	Barcelona	Spain
Ouovnofqaroqmz Ldqm Gqkr	Linz	Austria
Hlrdcfgz Uxerhmnkqfryc Mbfckrm De Veknqlaalx	Santander	Spain
Iyowihlb Cupcmi Dkecqitljiymlwpoi	L'hospitalet De Llobregat	Spain
Acohjet Spk z olwz	Poznan	Poland
Csgadj Hvmtzvcasie Eb Uqvistofgpzyn De Lwwjuac	Limoges	France
Avopbif Oqawtrxjcjw Nxsnczsff Sf Aoajcww E Bxpnpz E C Ajthdx Atnvlpuqppm	Alexandria	Italy
Annbled Upj Iuzza Dy Rklkuw Efvsmu	Reggio Emilia	Italy

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.04.2022
Belgium	Not recruiting	01.04.2022
Czechia	Not recruiting	01.04.2022
France	Recruiting	01.04.2022
Germany	Recruiting	01.04.2022
Hungary	Recruiting	01.04.2022
Italy	Recruiting	01.04.2022
Poland	Recruiting	01.04.2022
Spain	Recruiting	01.04.2022

Trial locations

Investigated Drugs:

Pirtobrutinib (LOXO-305) is a medication being studied for its effectiveness in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. It is designed to target specific proteins in cancer cells, potentially slowing down or stopping their growth. In this trial, it is being compared to another medication to see how well it works in improving the overall response rate in patients.

Ibrutinib is a medication used to treat certain types of cancer, including chronic lymphocytic leukemia and small lymphocytic lymphoma. It works by blocking a protein that helps cancer cells grow and divide. In this study, it is being used as a comparison to evaluate the effectiveness of pirtobrutinib in treating these conditions.

Chronic Lymphocytic Leukemia – 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, the abnormal cells can crowd out healthy blood cells, leading to issues like fatigue, infections, and swollen lymph nodes. As the disease advances, it can affect the body’s ability to fight infections and may cause anemia or bleeding problems.

Small Lymphocytic Lymphoma – This is a type of non-Hodgkin lymphoma that primarily affects the lymph nodes, but it is closely related to chronic lymphocytic leukemia. It involves the slow accumulation of small, mature lymphocytes in the lymphatic system. The disease progresses gradually, often without symptoms in the early stages. Over time, it can lead to swollen lymph nodes, fatigue, and an increased risk of infections. As it advances, it may affect other organs and tissues, impacting overall health.

Trial ID:

2023-507699-38-00

Protocol code:

LOXO-BTK-20030

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Pirtobrutinib and Ibrutinib for Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?