Non Hodgkin Lymphoma Clinical Trial

A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Summary

The purpose of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL. Participants may or may not have already had treatment for their cancer. Participation could last up to six years.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Adequate organ function
Platelets greater than or equal to (≥)50 x 10⁹/liter (L), hemoglobin ≥8 grams/deciliter (g/dL), and absolute neutrophil count ≥0.75 x 10⁹/L
Kidney function: Estimated creatinine clearance ≥30 milliliters per minute (mL/min)

Exclusion Criteria:

Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time preceding enrollment
Known or suspected central nervous system (CNS) involvement
A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disease
Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])
Significant cardiovascular disease
Active hepatitis B or hepatitis C
Active cytomegalovirus (CMV) infection
Active uncontrolled systemic bacterial, viral, or fungal infection
Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
Clinically significant active malabsorption syndrome or other condition likely to affect GI absorption of the oral-administered study treatments
Ongoing inflammatory bowel disease
Prior exposure to BTK inhibitor (covalent or noncovalent)
Concurrent use of investigational agent or anticancer therapy except hormonal therapy
Participants requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
Use of ≥ 20 mg prednisone daily or equivalent dose of steroid at the time of first dose of study drug
Vaccination with a live vaccine within 28 days prior to randomization
Participants receiving chronic therapy with a strong cytochrome P450 (CYP)3A inhibitor (except posaconazole and voriconazole) which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment.
Participants with known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or ibrutinib

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

650

Study ID:

NCT05254743

Recruitment Status:

Recruiting

Sponsor:

Loxo Oncology, Inc.

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 76 Locations for this study

See Locations Near You

Genesis Cancer Center
Hot Springs Arkansas, 71913, United States More Info
Contact
501-624-7700
Stephen (Fred) G Divers
Principal Investigator
Pacific Cancer Medical Center, Inc
Anaheim California, 92801, United States More Info
Contact
714-999-1465
Veena Charu
Principal Investigator
TOI Clinical Research
Cerritos California, 90703, United States More Info
Richy Agajanian
Principal Investigator
California Cancer Associates for Research and Excellence
San Marcos California, 92069, United States More Info
Contact
760-747-8935
Michael A Kosmo
Principal Investigator
Asclepes Research Centers Florida
Brooksville Florida, 34613, United States More Info
Contact
352-364-9401
Daniel A Kerr
Principal Investigator
Florida Cancer Specialists
Fort Myers Florida, 33901, United States More Info
Alexander Edward Glick
Principal Investigator
Cancer Specialists of North Florida -St Augustine
Jacksonville Florida, 32256, United States More Info
Contact
904-538-4488
Ayed O. Ayed
Principal Investigator
Florida Cancer Specialists
Saint Petersburg Florida, 33705, United States More Info
Jennifer Lyn Cultrera
Principal Investigator
Florida Cancer Specialists East
West Palm Beach Florida, 33401, United States More Info
Contact
561-366-4100
Shachar Peles
Principal Investigator
Hematology Oncology Clinic
Baton Rouge Louisiana, 70809, United States More Info
Contact
225-767-0822
Gerald Miletello
Principal Investigator
Tulane Cancer Center Office of Clinical Research
New Orleans Louisiana, 70112, United States More Info
Contact
504-988-6234
Nakhle Saba
Principal Investigator
American Oncology Partners of Maryland, PA
Bethesda Maryland, 20817, United States More Info
Contact
301-571-0019
Bruce D Cheson
Principal Investigator
TidalHealth Richard A. Henson Cancer Institute
Ocean Pines Maryland, 21811, United States More Info
Contact
410-543-7032
Justinian Ngaiza
Principal Investigator
TidalHealth Peninsula Regional, Inc.
Salisbury Maryland, 21801, United States More Info
Contact
410-543-7032
Justinian R Ngaiza
Principal Investigator
St. Vincent Frontier Cancer Center
Billings Montana, 59102, United States More Info
Patrick Wayne Cobb
Principal Investigator
Novant Cancer Institute Charlotte
Charlotte North Carolina, 28204, United States More Info
Contact
980-302-6600
Alan Skarbnik
Principal Investigator
Novant Health, Oncology Research Institute
Winston-Salem North Carolina, 27103, United States More Info
Contact
980-302-6600
Alan Skarbnik
Principal Investigator
Asante Rogue Regional Medical Center
Medford Oregon, 97504, United States More Info
Contact
541-789-5003
Aleksandra Sander
Principal Investigator
Cancer Care Associates of York
York Pennsylvania, 17403, United States More Info
Contact
717-741-9229
Chanh Huynh
Principal Investigator
Sarah Cannon Research Institute SCRI
Chattanooga Tennessee, 37404, United States More Info
Contact
423-622-6212
Bertrand M Anz III
Principal Investigator
Kelsey Research Foundation
Houston Texas, 77025, United States More Info
Contact
713-442-1700
Sunil Patel
Principal Investigator
Lumi Research
Kingwood Texas, 77339, United States More Info
Contact
832-553-3661
Saleha S Sajid
Principal Investigator
Virginia Cancer Institute
Richmond Virginia, 23228, United States More Info
Contact
804-287-3000
Yuvraj Choudhary
Principal Investigator
Hospital Italiano de Buenos Aires
ABB Ciudad Autónoma De Buenos Aire, 1199, Argentina More Info
Dorotea Fantl
Principal Investigator
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares
Santa Fe , 3000, Argentina More Info
Daniel Bar
Principal Investigator
One Clinical Research
Nedlands Western Australia, 6009, Australia More Info
Peter Thian Guan Tan
Principal Investigator
The Perth Blood Institute
West Perth , 6005, Australia More Info
Contact
08 9200 5300
Ross Baker
Principal Investigator
VITAZ
Sint-Niklaas Oost-Vlaanderen, 9100, Belgium More Info
Vanessa Van Hende
Principal Investigator
AZ Delta
Roeselare West Flanders, 8800, Belgium More Info
Contact
+3251237322
Lien Deleu
Principal Investigator
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven , 3000, Belgium More Info
Contact
+3216346880
Ann Janssens
Principal Investigator
Hospital de Clínicas de Ribeirão Preto
Ribeirão Preto São Paulo, 14051, Brazil More Info
Contact
16 98112-6986
Diego Villa Clé
Principal Investigator
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André São Paulo, 09060, Brazil More Info
Debora Rodrigues Bonito
Principal Investigator
Hospital Uopeccan - Centro de Pesquisa Clinica
Cascavel , 85806, Brazil More Info
Ademar Dantas da Cunha Junior
Principal Investigator
Hopital de L'Enfant Jesus
Québec , G1J 1, Canada More Info
Robert Delage
Principal Investigator
CeCim Biocinetic
Santiago Región Metropolitana, 83200, Chile More Info
Contact
+56958263308
Alexander Arellano
Principal Investigator
Centro de Estudios Clinicos SAGA
Providencia Santiago, 75006, Chile More Info
Contact
+56997890202
Alejandro Berkovits
Principal Investigator
Centro de Investigaciones Clínicas Viña del Mar (CIC)
Viña del Mar Valparaíso, 25200, Chile More Info
Contact
56 940254875
Christine Rojas Hopkins
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

650

Study ID:

NCT05254743

Recruitment Status:

Recruiting

Sponsor:


Loxo Oncology, Inc.

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.