Study on the Effectiveness and Safety of Pirtobrutinib vs. Ibrutinib for Patients with Previously Treated Mantle Cell Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Mantle Cell Lymphoma, which is a rare form of non-Hodgkin’s lymphoma. The study is comparing the effectiveness and safety of a new treatment called LOXO-305, also known by its code name pirtobrutinib, with other standard treatments chosen by doctors. These standard treatments are known as Bruton’s tyrosine kinase (BTK) inhibitors, which are a type of medication that helps to block certain proteins that encourage cancer cells to grow.

The purpose of the study is to see how well patients with previously treated Mantle Cell Lymphoma respond to pirtobrutinib compared to other BTK inhibitors. Participants in the study will be randomly assigned to receive either pirtobrutinib or a BTK inhibitor chosen by their doctor. The study will monitor the participants over a period of time to see how long they can live without their disease getting worse, which is known as progression-free survival.

During the study, participants will take the medication in the form of tablets, which are taken by mouth. The study will last for up to 48 weeks, and participants will have regular check-ups to monitor their health and the effects of the treatment. Some participants may receive a placebo, which is a tablet that looks like the medication but does not contain the active substance. The study aims to provide valuable information on the best treatment options for patients with Mantle Cell Lymphoma.

1 joining the study

Upon joining the study, the patient is confirmed to have mantle cell lymphoma and meets specific health criteria, such as adequate kidney function and blood cell counts.

The patient must have been previously treated with at least one line of therapy for mantle cell lymphoma.

2 randomization

The patient is randomly assigned to one of two groups: Arm A or Arm B.

Arm A receives pirtobrutinib as a single treatment.

Arm B receives a Bruton’s tyrosine kinase (BTK) inhibitor chosen by the investigator, which could be ibrutinib.

3 treatment administration

The patient takes the assigned medication orally in the form of tablets.

The dosage and frequency are determined by the study protocol and the investigator’s choice for Arm B.

4 monitoring and assessments

The patient’s health and response to the treatment are regularly monitored.

Progression-free survival is assessed according to specific criteria to determine the effectiveness of the treatment.

5 completion of the study

The study is estimated to end by September 30, 2025.

The patient’s participation continues until the study’s completion or until the treatment is no longer effective.

Who Can Join the Study?

  • Must have a confirmed diagnosis of Mantle Cell Lymphoma (MCL).
  • Must have a creatinine clearance of at least 30 mL/min. This is a measure of how well the kidneys are working.
  • Must have been treated with at least one previous type of systemic therapy for MCL.
  • Must have measurable disease according to the Lugano criteria, which is a way to assess the size and spread of cancer.
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. This is a scale used to assess how a disease affects a patient’s daily living abilities.
  • Must have an absolute neutrophil count of at least 0.75 × 109/L without needing support from medications that stimulate white blood cell production within 7 days of screening.
  • Must have a hemoglobin level of at least 8 g/dL without needing blood transfusions or medications that stimulate red blood cell production within 7 days of screening.
  • Must have a platelet count of at least 50 × 109/L without needing blood transfusions or medications that stimulate platelet production within 7 days of screening.
  • Must have AST and ALT levels that are no more than 3 times the upper limit of normal. These are 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 by the liver.
  • Both male and female participants are eligible.

Who Cannot Join the Study?

  • Patients who have not been previously treated for Mantle Cell Lymphoma cannot participate. Mantle Cell Lymphoma is a type of cancer that affects the lymph nodes.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are not able to provide informed consent, meaning they cannot understand and agree to the study procedures, cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate. This includes conditions that could make it unsafe for them to take part in the study.
  • Patients who are pregnant or breastfeeding cannot participate, as the study may involve risks to the baby.
  • Patients who are currently participating in another clinical trial cannot participate, as this could affect the results of the study.
  • Patients who have had a recent major surgery or are planning to have surgery during the study period cannot participate, as this could interfere with the study treatment.
  • Patients who have a known allergy or severe reaction to the study medication or similar drugs cannot participate, as this could be harmful.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hopitaux Universitaires Pitie Salpetriere Paris France
Hospital Vall d’Hebron Barcelona Spain
Odense University Hospital Odense Denmark
Ospedale San Raffaele S.r.l. Milan Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l. Meldola Italy
Hospital Clinic De Barcelona Barcelona Spain
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Rotterdam The Netherlands
Centre Hospitalier Regional Universitaire De Tours Tours France
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
IRCCS Ospedale Policlinico San Martino Genoa Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
CHRU De Nancy Vandoeuvre Les Nancy France
Centre Hospitalier Universitaire De Nantes Nantes France
Klinikum der Universitaet Muenchen AöR Munich Germany
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
Ordensklinikum Linz GmbH Linz Austria
Katholieke Universiteit te Leuven Leuven Belgium
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universitair Ziekenhuis Gent Gent Belgium
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Institut Catala D’oncologia L'hospitalet De Llobregat Spain
Servei De Salut De Les Illes Balears Palma Spain
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli Lublin Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi Lodz Poland
Azienda Socio Sanitaria Territoriale Dei Sette Laghi Varese Italy
Hospital Universitario De Navarra Pamplona Spain
Institut Curie – Site Paris Paris France
Hospital Universitario Virgen De La Victoria Malaga Spain
Centre Henri Becquerel Rouen France
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello Palermo Italy
Groupement Des Hopitaux De L’Institut Catholique De Lille Lomme France
Aarhus University Hospital Aarhus Denmark
Champalimaud Clinical Centre Lisbon Portugal
Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria Alexandria Italy
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu Wroclaw Poland
Azienda USL IRCCS Di Reggio Emilia Reggio Emilia Italy
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Centre Hospitalier Universitaire De Poitiers Poitiers France
Hospital Universitario Infanta Leonor Madrid Spain
SCRI CCCIT Ges.m.b.H. Salzburg Austria

Other Sites

Site Name City Country Status
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E. Lisbon Portugal
Pratia S.A. Skorzewo Poland
Anfgqbj Son z oqiv Poznan Poland
Ipnas Ctwm Rionero In Vulture Italy
Bihzuc Zlzologqwl Roosendaal The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
08.04.2021
Belgium Belgium
Not recruiting
08.04.2021
Czechia Czechia
Not recruiting
08.04.2021
Denmark Denmark
Not recruiting
08.04.2021
France France
Not recruiting
08.04.2021
Germany Germany
Not recruiting
08.04.2021
Italy Italy
Not recruiting
08.04.2021
Poland Poland
Not recruiting
08.04.2021
Portugal Portugal
Not recruiting
08.04.2021
Spain Spain
Not recruiting
08.04.2021
The Netherlands The Netherlands
Not recruiting
08.04.2021

Trial locations

Investigated Drugs:

LOXO-305: This is a medication being tested in the trial for its effectiveness in treating patients with Mantle Cell Lymphoma who have been previously treated but have not received a BTK inhibitor before. It is being studied to see if it can help stop the progression of the disease.

Bruton’s Tyrosine Kinase (BTK) Inhibitors: These are a group of medications that work by blocking a specific protein that helps cancer cells grow. In this trial, patients may receive one of these inhibitors as chosen by their doctor. The goal is to see how well these medications work compared to LOXO-305 in controlling the disease.

Investigated Diseases:

Mantle Cell Lymphoma – Mantle cell lymphoma is a type of non-Hodgkin lymphoma, which is a cancer that begins in the cells of the immune system. It specifically affects B-cells, a type of white blood cell that helps fight infections. The disease is characterized by the abnormal growth of B-cells in the lymph nodes, spleen, bone marrow, and sometimes other organs. As it progresses, it can lead to symptoms such as swollen lymph nodes, fatigue, fever, and weight loss. The disease often spreads to other parts of the body, including the gastrointestinal tract and bone marrow. It is considered a rare form of lymphoma and can vary in how quickly it progresses.

Trial ID:
2023-507695-52-00
Protocol code:
LOXO-BTK-20019
NCT ID:
NCT04662255
Trial Phase:
Therapeutic confirmatory (Phase III)

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