Study Comparing Pirtobrutinib to Bendamustine and Rituximab for Untreated 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 a type of cancer called Chronic Lymphocytic Leukemia (CLL) and its closely related condition, Small Lymphocytic Lymphoma (SLL). These are cancers that affect a type of white blood cell called lymphocytes, which are part of the immune system. The study is comparing two different treatments for patients who have not yet received any treatment for their CLL or SLL. One treatment involves a medication called Pirtobrutinib, also known by its code name LOXO-305, which is taken as a tablet by mouth. The other treatment combines two drugs, Bendamustine and Rituximab, which are given through a vein in the arm (intravenous use).

The purpose of the study is to evaluate how well Pirtobrutinib works on its own compared to the combination of Bendamustine and Rituximab. Participants in the study will be randomly assigned to receive either Pirtobrutinib or the combination of Bendamustine and Rituximab. The study will last for a period of time, with Pirtobrutinib being taken for up to 52 weeks, while the combination treatment will be given for up to 6 months. During the study, participants will have regular check-ups and tests to monitor their health and the effects of the treatment.

This study is designed to help researchers understand which treatment is more effective in managing Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma in patients who have not been treated before. The information gathered from this study may contribute to better treatment options for these conditions in the future.

1 enrollment

Upon joining the study, the patient is assigned to one of two groups: Arm A or Arm B. This assignment is random and determines the treatment plan.

2 treatment initiation

In Arm A, the patient receives pirtobrutinib as a single treatment. This medication is taken orally. The specific dosage and frequency are determined by the study protocol.

In Arm B, the patient receives a combination of bendamustine and rituximab. Bendamustine is administered intravenously, while rituximab is also given intravenously. The dosage and schedule are specified in the study protocol.

3 treatment duration

The treatment continues for a period defined by the study protocol. The duration may vary based on the patient’s response and any side effects experienced.

4 monitoring and assessments

Throughout the trial, regular monitoring and assessments are conducted to evaluate the patient’s health and response to the treatment. This includes blood tests, imaging studies, and other necessary evaluations.

5 end of treatment

Upon completion of the treatment phase, the patient’s condition is assessed to determine the effectiveness of the therapy. Follow-up visits may be scheduled to monitor long-term outcomes.

Who Can Join the Study?

Must be 18 years or older at the time of joining the study.
Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). This means certain types of white blood cells, called B-cells, must show specific markers like CD5 and CD23.
Must need treatment based on specific criteria, such as:
- Worsening anemia (low red blood cells) or thrombocytopenia (low platelets).
- Enlarged or worsening spleen or lymph nodes.
- Increasing number of white blood cells over a short period.
- Autoimmune issues not responding well to treatment.
- Symptoms affecting other body parts like skin or lungs.
- Symptoms like significant weight loss, severe tiredness, fevers, or night sweats.
Must have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) scale, which measures daily living abilities.
Must have adequate organ function based on recent lab tests.
Must have completed certain waiting periods after any recent radiation treatments.
Women who can have children and their partners must agree to use effective birth control methods during the study and for a specified time after the last dose of treatment.

Who Cannot Join the Study?

Patients with other types of cancer that are not Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or take the study medication as required.
Patients who are pregnant or breastfeeding.
Patients with severe or uncontrolled medical conditions that could interfere with the study.
Patients who have participated in another clinical trial recently.
Patients who have allergies to the study medication or its ingredients.
Patients with a history of certain heart conditions.
Patients with active infections that require treatment.
Patients who have had a major surgery recently.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Azienda Sanitaria Universitaria Giuliano Isontina	Trieste	Italy
Azienda Ospedaliera S Maria Di Terni	Terni	Italy
Hospital Santa Maria Della Misericordia	Perugia	Italy
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli	Lublin	Poland
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
Stadt Wien Wiener Gesundheitsverbund	Vienna	Austria
SCRI CCCIT Ges.m.b.H.	Salzburg	Austria
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Umbal – Prof. D-R Stoyan Kirkovich AD	Stara Zagora	Bulgaria
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz	Szekesfehervar	Hungary
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	Bulgaria
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Poland
Pratia Hematologia Sp. z o.o.	Katowice	Poland
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej	Biala Podlaska	Poland
University Of Debrecen	Debrecen	Hungary
Institutul Regional De Oncologie Iasi	Iasi	Romania
Virgen del Rocío University Hospital	Sevilla	Spain
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Centre Hospitalier Le Mans	Le Mans	France
Fakultni Nemocnice Brno	Brno	Czechia
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz	Nyiregyhaza	Hungary
Hospital Universitario Virgen De Valme	Sevilla	Spain
Pratia S.A.	Skorzewo	Poland
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie	Lublin	Poland
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD	Sofia	Bulgaria
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
IRCCS CROB	Rionero In Vulture	Italy
Specialized Hospital For Active Treatment Of Hematological Diseases EAD	Sofia	Bulgaria
Fundeni Clinical Institute	Bucharest	Romania
Mkzbzaoqo Iovpbopfbk Crhhcunj Sojlnlkb Szl z ohkh	Warsaw	Poland
Szzsmtei Croisv Mbbwtsofs Ffyklicxfpy Cggsetj	Craiova	Romania
Aanapzv Scg z ovys	Poznan	Poland
Ikhcytye Rakvltllx Pqj Lr Swvfiq Dhx Tigbhe Dndd Ahbeewa Isam Svtjjj	Meldola	Italy
Nmldcsby Irqhnnom Oasoxjytv Iml Myxcw Sbkbowhvweakiplntjugfelgdivq Ikkngamk Bmxthgoc	Cracow	Poland
Urxwkfuqvlwsje Calfhcq Kxpbaaotf	Gdansk	Poland
Hobxtzxd Dg Lx Sxtdq Cckg I Szah Pho	Barcelona	Spain
Aznvqvd Owncbcxnffu Pyra Gyvprkbz Xzspd	Bergamo	Italy

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	28.03.2022
Bulgaria	Not recruiting	28.03.2022
Czechia	Not recruiting	28.03.2022
France	Not recruiting	28.03.2022
Hungary	Not recruiting	28.03.2022
Italy	Not recruiting	28.03.2022
Poland	Not recruiting	28.03.2022
Portugal	Not recruiting	28.03.2022
Romania	Not recruiting	28.03.2022
Spain	Not recruiting	28.03.2022

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 being tested as a single treatment option to see how well it works in stopping the progression of these diseases.

Bendamustine is a chemotherapy drug used to treat certain types of cancer, including chronic lymphocytic leukemia. It works by interfering with the growth of cancer cells, which are eventually destroyed.

Rituximab is a medication that targets specific proteins on the surface of cancer cells. It is used in combination with other drugs to treat certain types of blood cancers, including chronic lymphocytic leukemia. It helps the immune system to identify and attack cancer cells.

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 anemia, infections, and bleeding problems. The disease often affects older adults and can be detected through routine blood tests. As it advances, it may cause swollen lymph nodes, fatigue, and weight loss.

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 and may not present symptoms initially. As it develops, it can lead to enlarged lymph nodes, spleen, or liver, and may cause fatigue and night sweats. It is typically diagnosed in older adults and shares many characteristics with chronic lymphocytic leukemia.

Trial ID:

2024-511599-33-00

Protocol code:

LOXO-BTK-20023

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Pirtobrutinib to Bendamustine and Rituximab for Untreated Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?