Study Comparing Pirtobrutinib with Idelalisib and Rituximab or Bendamustine and Rituximab for Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of blood cancer known as Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). The study is comparing the effectiveness of a new treatment called pirtobrutinib (also known by its code name LY3527727) against other treatment options chosen by doctors. These options include a combination of idelalisib and rituximab, or bendamustine and rituximab. The purpose of the study is to see how well these treatments work in patients who have already been treated with a type of medication called a BTK inhibitor.

Participants in the study will be randomly assigned to one of two groups. One group will receive pirtobrutinib as a single treatment, while the other group will receive one of the doctor-chosen combinations. The study will monitor the participants over a period to see how long they can live without the disease getting worse, which is known as progression-free survival. The treatments will be given in different forms, such as tablets taken by mouth or solutions given through a vein.

The study aims to provide valuable information about the effectiveness of pirtobrutinib compared to existing treatment options for patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma. This research could help improve future treatment strategies for these conditions. Participants will be closely monitored throughout the study to ensure their safety and to gather important data on the treatments’ effects.

1 enrollment

Upon joining the study, eligibility is confirmed based on specific criteria such as age, kidney function, and previous treatments.

A signed informed consent form is required, indicating understanding and agreement to comply with study requirements.

2 randomization

Participants are randomly assigned to one of two groups: Arm A or Arm B.

Arm A receives pirtobrutinib as a single treatment.

Arm B receives a combination of either idelalisib and rituximab or bendamustine and rituximab.

3 treatment administration

In Arm A, pirtobrutinib is taken orally in tablet form.

In Arm B, idelalisib is taken orally, while rituximab and bendamustine are administered intravenously.

The specific dosage and frequency are determined by the study protocol and the healthcare team.

4 monitoring and assessments

Regular monitoring is conducted to assess health status and response to treatment.

Assessments include blood tests, imaging, and other evaluations as required by the study.

5 follow-up

After completing the treatment phase, follow-up visits are scheduled to monitor long-term effects and overall health.

The duration of follow-up is specified by the study protocol.

Who Can Join the Study?

Must be 18 years or older at the time of joining the study.
Must have an estimated creatinine clearance of at least 30 mL/min. This is a measure of how well the kidneys are working.
Must be willing and able to give signed informed consent, which means agreeing to the study’s rules and requirements.
Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) that needs treatment, as defined by specific medical guidelines.
Must have been previously treated with a type of medication called a covalent BTK inhibitor.
Must have an ECOG performance status of 0 to 2. This is a scale that measures how well a person can perform daily activities.
Must have an absolute neutrophil count of at least 0.75 x 10⁹/L without support, or at least 0.50 x 10⁹/L if there is bone marrow involvement. Neutrophils are a type of white blood cell important for fighting infections.
Must have a hemoglobin level of at least 8 g/dL, or at least 6 g/dL if there is bone marrow involvement. Hemoglobin is a protein in red blood cells that carries oxygen.
Must have a platelet count of at least 50 x 10⁹/L, or at least 75 x 10⁹/L if certain treatments are chosen. Platelets help with blood clotting.
Must have AST and ALT levels that are no more than 3 times the upper limit of normal. These are liver enzymes that help assess liver function.
Must have a total bilirubin level that is no more than 1.5 times the upper limit of normal. Bilirubin is a substance made during the breakdown of red blood cells.

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, which means they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland

Other Sites

Site Name	City	Country
KBC Zagreb	Zagreb	Croatia
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Azienda Ospedaliera S Maria Di Terni	Terni	Italy
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Hospital Santa Maria Della Misericordia	Perugia	Italy
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Instytut Hematologii I Transfuzjologii	Warsaw	Poland
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli	Lublin	Poland
Hospital Universitario Infanta Leonor	Madrid	Spain
SCRI CCCIT Ges.m.b.H.	Salzburg	Austria
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza	Brzozow	Poland
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Azienda Ospedaliera Papardo	Messina	Italy
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
University Of Debrecen	Debrecen	Hungary
Virgen del Rocío University Hospital	Sevilla	Spain
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet	Budapest	Hungary
Pratia S.A.	Skorzewo	Poland
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Wojewodzki Szpital Specjalistyczny W Legnicy	Legnica	Poland
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Universita Degli Studi Di Brescia	Brescia	Italy
Beaumont Hospital	Dublin	Ireland
Okpflonrffffmq Lldu Gqbv	Linz	Austria
Hgrojifj Ulsrkkeqpeujn Mhprbhe Dn Vgtkybhraj	Santander	Spain
Wuafmnbqwmj Wzxfazgnardbhyibyzob Cyxtxmp Oiofmbyut I Tzjxwvkfbynub Ia Mbumwfjglbd W Lpepc	Lodz	Poland
Ledkcopx Ogbwrofevsaw Snpretdssmzsqvwiz	Luebeck	Germany
Cpwdcn Hjqxehqtwyn Rmnzllcj Uyemlxaezhzar Dn Tvywr	Tours	France
Ajfcjng Oifzeqkvbvn Nysvmocdp Su Antyjce E Bqyhrt E C Apxbtu Akwlwvpvwfn	Alexandria	Italy

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	16.06.2021
Belgium	Not recruiting	16.06.2021
Croatia	Not recruiting	16.06.2021
Czechia	Not recruiting	16.06.2021
France	Not recruiting	16.06.2021
Germany	Not recruiting	16.06.2021
Hungary	Not recruiting	16.06.2021
Ireland	Not recruiting	16.06.2021
Italy	Not recruiting	16.06.2021
Poland	Not recruiting	16.06.2021
Spain	Not recruiting	16.06.2021

Trial locations

Investigated drugs:

LOXO-305: This is a medication being tested in the trial for its effectiveness in treating chronic lymphocytic leukemia or small lymphocytic lymphoma. It is being used as a single treatment to see how well it works in patients who have already been treated with other BTK inhibitors.

Idelalisib: This medication is used in combination with another drug, rituximab, to treat certain types of blood cancers. In this trial, it is one of the options chosen by the investigator to compare its effectiveness against LOXO-305.

Rituximab: This is a medication that targets specific cells in the immune system and is used to treat various types of blood cancers. In this trial, it is combined with either idelalisib or bendamustine to see how well these combinations work compared to LOXO-305.

Bendamustine: This is a chemotherapy drug used to treat certain types of blood cancers. In this trial, it is combined with rituximab to evaluate its effectiveness against LOXO-305 in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

Chronic Lymphocytic Leukemia – This is a type of cancer that affects the blood and bone marrow, characterized by the production of too many abnormal white blood cells. These cells accumulate over time, crowding out healthy blood cells and impairing the immune system. The disease often progresses slowly, and many people may not experience symptoms for years. As it advances, it can lead to swollen lymph nodes, fatigue, and an increased risk of infections. The abnormal cells can also spread to other parts of the body, such as the liver and spleen.

Small Lymphocytic Lymphoma – This is a type of non-Hodgkin lymphoma that primarily affects the lymph nodes. It is closely related to chronic lymphocytic leukemia, with the main difference being the location of the cancerous cells. In small lymphocytic lymphoma, the abnormal cells are mainly found in the lymph nodes rather than the blood and bone marrow. The disease typically progresses slowly, and symptoms may include swollen lymph nodes, fatigue, and night sweats. Over time, it can affect other organs and tissues, leading to further complications.

Trial ID:

2023-507697-40-00

Protocol code:

LOXO-BTK-20020

NCT ID:

NCT04666038

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Pirtobrutinib with Idelalisib and Rituximab or Bendamustine and Rituximab for Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?