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 37 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
California Cancer Associates for Research and Excellence
San Marcos California, 92069, United States More Info
Contact
760-747-8935
Michael A Kosmo
Principal Investigator
Innovative Clinical Research Institute
Whittier California, 90603, United States More Info
Contact
562-693-4477
Richy Agajanian
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
American Oncology Partners of Maryland, PA
Bethesda Maryland, 20817, United States More Info
Contact
301-571-0019
Bruce D Cheson
Principal Investigator
St. Vincent Frontier Cancer Center
Billings Montana, 59102, United States More Info
Patrick Wayne Cobb
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
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares
Santa Fe , 3000, Argentina More Info
Daniel Bar
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
Blood Institute of the Chinese Academy of Medical science
Tianjin Tianjin, 30002, China More Info
Contact
15900265415
Shuhua Yi
Principal Investigator
Tianjin Medical University General Hospital
Tianjin Tianjin, 30005, China More Info
Contact
13920350233
Rong Fu
Principal Investigator
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan , 43002, China More Info
Guohui Cui
Principal Investigator
Fakultni nemocnice Kralovske Vinohrady
Praha 10 , 100 3, Czechia More Info
Jan Novak
Principal Investigator
Hopital de la Pitie Salpetriere
Paris Cedex 13, 75651, France More Info
Damien Roos-Weil
Principal Investigator
CHU de Nantes - Hotel Dieu
Nantes Cedex 1, 44093, France More Info
Anne Lok
Principal Investigator
Centre Hospitalier Lyon Sud
Pierre Benite Cedex, 69495, France More Info
Emmanuelle Ferrant
Principal Investigator
CHRU De Tours
Tours Tours Cedex 9, 37044, France More Info
Caroline Dartigeas
Principal Investigator
CHD Vendee
La Roche sur Yon , 85000, France More Info
Contact
+33251446173
Bruno Villemagne
Principal Investigator
Centre Hospitalier du Mans
Le Mans , 72000, France More Info
Kamel Laribi
Principal Investigator
Hématologie Clinique et Thérapie Cellulaire
Limoges , 87042, France More Info
Nataliya Dmutruk
Principal Investigator
Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen
Rouen Cedex , 76038, France More Info
Stephane Lepretre
Principal Investigator
Seoul National University Hospital
Seoul Seoul, Korea, 03080, Korea, Republic of More Info
Sung-Soo Yoon
Principal Investigator
Hospital Universitario Infanta Leonor-INTERNAL MED
Madrid , 28031, Spain More Info
Contact
+34619249275
Jose A Hernandez Rivas
Principal Investigator
Hospital Universitario Virgen Macarena
Sevilla , 41009, Spain More Info
Contact
+34619848594
Alicia Rodriguez Fernandez
Principal Investigator
Hospital Universitario Virgen Del Rocio
Sevilla , 41013, Spain More Info
Contact
+34955013277
Fatima de la Cruz
Principal Investigator
Chang Gung Memorial Hospital - Chiayi
Putz Chiayi Hsien, 61363, Taiwan More Info
Chih-Cheng Chen
Principal Investigator
Chang Bing Show Chwan Memorial Hospital
Changhua , 50544, Taiwan More Info
Cheng-Shyong Chang
Principal Investigator
National Cheng-Kung Uni. Hosp.
Tainan , 704, Taiwan More Info
Tsai-Yun chen
Principal Investigator
Koo Foundation Sun Yan-Sen Cancer Center
Taipei , 11259, Taiwan More Info
Tran-Der Tan
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.