Study of Pirtobrutinib, Venetoclax and Rituximab combination compared to Venetoclax and Rituximab in previously treated Chronic Lymphocytic Leukemia patients

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What is this study about?

This study focuses on treating patients with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, which are types of blood cancers affecting white blood cells. The study will test a combination of three medications: pirtobrutinib, venetoclax, and rituximab. The purpose is to determine if adding pirtobrutinib to the combination of venetoclax and rituximab improves outcomes for patients who have already received previous treatment for their disease.

The medications will be given in different ways: pirtobrutinib and venetoclax are taken as tablets by mouth, while rituximab is given through an intravenous infusion (through a vein). The study compares two groups of patients – one group receives all three medications (pirtobrutinib, venetoclax, and rituximab), while the other group receives only venetoclax and rituximab.

During the study, patients will receive treatment for up to two years. Throughout this time, doctors will monitor how well the treatment is working and track any changes in the disease. The main focus will be on how long patients remain without their disease getting worse after starting treatment.

1 Initial evaluation

You will undergo an evaluation to confirm your chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) diagnosis.

Medical tests will be performed to check your blood counts, including platelets, hemoglobin, and neutrophil count.

Your kidney function and overall physical condition will be assessed using the ECOG Performance Status scale.

2 Treatment assignment

You will be randomly assigned to one of two treatment groups:

Group 1: Pirtobrutinib (taken by mouth) plus venetoclax (taken by mouth) and rituximab (given through a vein)

Group 2: Venetoclax (taken by mouth) and rituximab (given through a vein)

3 Treatment period

Your treatment will follow a fixed-duration schedule.

You will take oral medications daily according to your assigned treatment group.

Rituximab will be administered through an intravenous infusion according to a predetermined schedule.

Regular assessments will monitor your response to treatment and any side effects.

4 Follow-up period

After completing treatment, you will continue to be monitored to assess how well the therapy worked.

Regular check-ups will track your disease status and overall health.

The study will continue until 2027.

Who Can Join the Study?

  • Must be 18 years or older to participate
  • Must have a confirmed diagnosis of CLL/SLL (Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma) that requires treatment according to current medical guidelines
  • Must have received at least one previous treatment, which may include a specific type of therapy called BTK inhibitor (a medication that blocks certain proteins involved in cancer growth)
  • Must have adequate blood counts:
    – Platelets: at least 50,000 per microliter
    – Hemoglobin: at least 8 grams per deciliter
    – Neutrophils (white blood cells that fight infection): at least 1,000 per microliter
  • Must have proper functioning organs
  • Must have an ECOG Performance Status of 0-2 (a scale that measures a person’s ability to perform daily activities and self-care, where 0 means fully active and 2 means able to do light activities but resting less than half the day)
  • Must have kidney function showing creatinine clearance of at least 30 milliliters per minute (a measure of how well your kidneys are filtering waste from your blood)

Who Cannot Join the Study?

  • Prior treatment with BTK inhibitors (medications that block an enzyme called Bruton’s tyrosine kinase)
  • Active or uncontrolled autoimmune disease requiring systemic treatment (conditions where the immune system attacks healthy cells)
  • Known active central nervous system lymphoma (cancer in the brain or spinal cord)
  • History of other cancers within 2 years before starting the study, except for successfully treated skin cancers or early-stage cancers
  • Significant heart problems including:
    • Uncontrolled irregular heartbeat
    • Heart failure with reduced heart function
    • Recent heart attack
  • Active, uncontrolled infections requiring treatment
  • Known hepatitis B or C infection or HIV positive status
  • Major surgery within 4 weeks before starting the study
  • Pregnancy or breastfeeding
  • Mental conditions that could interfere with study participation
  • Use of medications that strongly affect certain liver enzymes (CYP3A inhibitors or inducers)
  • Any condition that, in the opinion of the study doctor, would make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Ospedale San Raffaele S.r.l. Milan Italy
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Karolinska University Hospital Solna Sweden
Centre Hospitalier Universitaire De Nantes Nantes France
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Haematologisch Onkologische Schwerpunktpraxis Wuerzburg Germany
Hopital Beaujon Clichy France
Mmusikner Igxnqvndlh Cdqvaamj Svohxehu Smv z olxc Warsaw Poland
Uqdinabpuf Ot Dqcgepar Debrecen Hungary
Hzyvleg Jghbiesd Haine-Saint-Paul Belgium
Hhkyromf Vdkv drdutzgh Barcelona Spain
Vtenyq djs Rdkhg Upbqckzcho Hwtqjasx Sevilla Spain
Uxptpggmzs Hajcdjpo Czeydky Cologne Germany
Agyz Gpeqii Ozyfshxp Mugqfnzspxqtk Naxywzdp Milan Italy
Iruimgwa Rhtxbzaba Pxt Lw Sufvau Drw Tdotjv Dwyc Arknncg Ijfc Spwwgj Meldola Italy
Rppshg Sfmhq Soztte Urusqacveqqtkvackxb Lund Sweden
Hndwuldb Cjkvug Dk Bgemxlonq Barcelona Spain
Fnjkivme Npftugqlk Bimx Brno Czechia
Cpthpg Huojickpzkp Rwyrccve Ungvjyspxynmd Du Tjbzg Tours France
Hcujutmr Uwemzueuwsftj Fzifpzpqr Jwbxxdt Dpfv Madrid Spain
Fprjafxx Nptwtbseq Kmspbqwzl Voqdyydrl Prague Czechia
Ckqcma Hxdriybosxw Usnceaozhmsqx Dc Mpdaczbmamj Montpellier France
Antgrje Oobbcvdrtha Udoycztyzcfqc Cqhnivbvwizn Douha Snylrf E Dxofy Srzvwis Dk Tcdwjx Turin Italy
Cxtc Dn Nrxnh Vandoeuvre Les Nancy France
Adkcnfp Oqtwrvlpdjumcssmixrnuvbpk Mcaubteq Dxxju Ccxvem Novara Italy
Ujnflbghucfp Lpgiavx Leipzig Germany
Cveehi Hboytnkimxs Urkwjqcldntmy Dz Raglye Rennes France
Rvhkusdtcibvzi Copenhagen Denmark
Ampxllj Uufqh Sdvehpkgq Llpsno Du Baqmjrx Bologna Italy
Uoqnmrwpraguniqioabkm Ebeto Amx Essen Germany
Unwsxbomgihh Ztclqcznqo Gory Gent Belgium
Cbkpww Hwuoxnpsbta Lucd Sxr Pierre Benite France
Hgoxxevm Uqipckqpckhgh Ppqwcg Dy Hltmwn Dr Moqdetbepoc Majadahonda Spain
Ujrbmamduotojaeqx Dhpay Sdrjf Df Fkiptjr Ferrara Italy
Waghhnneuvr Wklxyxqbotkbzegthqlp Cjytqwk Olpasdgji I Tdxmyuzuxpwvw Ir Mwbojhndzoa W Lvhdh Lodz Poland
Sitpcbqp Ptwkikttq Srk z olsr Gdynia Poland
Hrpvushu Uensnsshstlxjc Swdytnndzt &ftohtw Hdvmlge db Hmlboyicaai STRASBOURG, Alsace France
Cfuzjj Hnsna Bvnyyzgfg Rouen France
Pmvuwv Hheqhpeegox Sak z oqpu Katowice Poland
Ovppwsgc Orwikqfogw Iqvuanj Budapest Hungary
Sahazk Vobwxierh Kimoym Mkm Ozkcyq Kzrcig Kaposvar Hungary
Cekrwfpf Vvtgto Hbll Le Mans France
Cduubj Hkwworgnwhw Er Uwktcklcyfyru Dt Lbirbta Limoges France
Aasalavhey Pvjvfbtp Heklrhet Dk Pcpst Paris France
Hkrikuce Uuowejjwqjryt Qaulrmzzwoq Milptk Pozuelo De Alarcon Spain
Snebocrrodq Pjzwtgmec Scyhgch Kpxvirhap Nx 1 W Lpfovzvl Lublin Poland
Mqwxzize Kzopxi gjokl Munich Germany
Cenmsp Hoopzomsdzy Ujtckpcqlfxja Dx Ppvyonah Poitiers France
Uirncdtxli Hqjdiwkb Wmghihkag Waterford Ireland
Hwllygtq Urrvwyfcxmitf Izcldoc Lftdrj Madrid Spain
Hokhdxgr Csbho dnu Sev Marbella Spain
Pqqybg Soeq Skorzewo Poland
Vhlavwlso Fldimkaj Nrumumtei V Pcdfz Prague Czechia
Cyqrkf Hwcwieemioy Uvgzoxavtmbjj Dbabiw Gwqdmyk Stfkunvrtwpisazlvrkuzwufgi Namur Belgium

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
02.11.2021
Czechia Czechia
Not recruiting
02.11.2021
Denmark Denmark
Not recruiting
02.11.2021
France France
Not recruiting
02.11.2021
Germany Germany
Not recruiting
02.11.2021
Hungary Hungary
Not recruiting
02.11.2021
Ireland Ireland
Not recruiting
02.11.2021
Italy Italy
Not recruiting
02.11.2021
Poland Poland
Not recruiting
02.11.2021
Spain Spain
Not recruiting
02.11.2021
Sweden Sweden
Not recruiting
02.11.2021

Trial locations

Pirtobrutinib (also known as LOXO-305) is a medication that belongs to the class of BTK inhibitors. It works by blocking specific proteins that help cancer cells grow and survive. This medication is being studied as a new treatment option for patients with chronic lymphocytic leukemia and small lymphocytic lymphoma.

Venetoclax is a medication that works by blocking a protein called BCL-2, which helps cancer cells survive. By blocking this protein, venetoclax can cause cancer cells to die. It is already approved for treating certain types of blood cancers.

Rituximab is an antibody therapy that targets specific proteins (CD20) found on the surface of certain blood cancer cells. It helps the immune system identify and destroy these cancer cells. Rituximab has been used for many years to treat various types of blood cancers and autoimmune conditions.

Chronic Lymphocytic Leukemia – A slow-growing blood cancer that starts in white blood cells called lymphocytes in the bone marrow. These abnormal cells gradually build up in the blood, bone marrow, and lymph nodes. The disease typically develops over months or years, with many people not showing symptoms in early stages. As it progresses, it can cause swollen lymph nodes, fatigue, and increased risk of infections. This condition sometimes occurs together with Small Lymphocytic Lymphoma, which is essentially the same disease but primarily affects the lymph nodes rather than the blood and bone marrow.

Small Lymphocytic Lymphoma – A type of cancer that affects the lymphocytes, a kind of white blood cell that helps the body fight infection. The disease mainly involves the lymph nodes, causing them to become enlarged. It is considered the same disease as Chronic Lymphocytic Leukemia but with a different pattern of where the cancer cells collect in the body. People with this condition may experience fatigue, night sweats, and unexplained weight loss.

Trial ID:
2023-507698-16-00
Protocol code:
LOXO-BTK-20022
NCT ID:
NCT04965493
Trial Phase:
Therapeutic confirmatory (Phase III)

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