RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of Part 1 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. The purpose of Part 2 of this study evaluates pirtobrutinib monotherapy in treatment-naïve participants with CLL/SLL with 17p deletions. Participation could last up to six years for Part 1. Participation could last up to 2 years for Part 2.

Official Title

A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314)

Quick Facts

Study Start:2022-07-22
Study Completion:2028-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05254743

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
  2. * Part 1 - Known 17p deletion status (wildtype or deleted). Part 2 - Must have deletion of 17p as determined by FISH testing
  3. * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  4. * Adequate organ function
  5. * Platelets greater than or equal to ≥ 50 x 10⁹/liter (L) or ≥30 x 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis,
  6. * Hemoglobin ≥8 grams/deciliter (g/dL) or ≥6 g/dL in participants with documented bone marrow involvement considered to impair hematopoiesis
  7. * Absolute neutrophil count ≥0.75 x 10⁹/L or ≥0.50 × 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis
  8. * Kidney function: Estimated creatinine clearance ≥30 milliliters per minute (mL/min)
  1. * Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time preceding enrollment
  2. * Known or suspected central nervous system (CNS) involvement
  3. * A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disease
  4. * Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia \[AIHA\], idiopathic thrombocytopenic purpura \[ITP\])
  5. * Significant cardiovascular disease including ejection fraction \< 40% and any grade ongoing atrial fibrillation or atrial flutter
  6. * Hepatitis B or hepatitis C testing indicating active/ongoing infection, based on Screening laboratory tests
  7. * Active cytomegalovirus (CMV) infection
  8. * Active uncontrolled systemic bacterial, viral, or fungal infection
  9. * Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
  10. * Clinically significant active malabsorption syndrome or other condition likely to affect GI absorption of the oral-administered study treatments
  11. * Ongoing inflammatory bowel disease
  12. * Previous treatment for CLL/SLL - Part 1: Treatment-naïve and previously treated, except prior exposure to BTK inhibitor (covalent or noncovalent).
  13. * Concurrent use of investigational agent or anticancer therapy except hormonal therapy
  14. * Participants requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
  15. * Use of \> 20 mg prednisone daily or equivalent dose of steroid at the time of first dose of study drug
  16. * Vaccination with a live vaccine within 28 days prior to randomization
  17. * 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
  18. * Participants with known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or ibrutinib

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
1-317-615-4559
ClinicalTrials.gov@lilly.com

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
STUDY_DIRECTOR
Eli Lilly and Company

Study Locations (Sites)

Genesis Cancer Center
Hot Springs, Arkansas, 71913
United States
Pacific Cancer Medical Center, Inc
Anaheim, California, 92801
United States
Alta Bates Summit Medical Center
Berkeley, California, 94705
United States
TOI Clinical Research
Cerritos, California, 90703
United States
Stanford School of Medicine-Cancer Clinical Trials Office
Palo Alto, California, 94304
United States
Eisenhower Army Medical Center
Rancho Mirage, California, 92270
United States
Sharp Memorial Hospital
San Diego, California, 92123
United States
California Cancer Associates for Research and Excellence
San Marcos, California, 92069
United States
Eastern Connecticut Hematology/Oncology Assoc.
Norwich, Connecticut, 06360
United States
Asclepes Research Centers Florida
Brooksville, Florida, 34613
United States
Florida Cancer Specialists
Fort Myers, Florida, 33901
United States
Cancer Specialists of North Florida -St Augustine
Jacksonville, Florida, 32256
United States
Lakeland Regional Health Systems Inc
Lakeland, Florida, 33805
United States
Florida Cancer Specialists
Saint Petersburg, Florida, 33705
United States
Florida Cancer Specialists East
West Palm Beach, Florida, 33401
United States
Summit Cancer Care, P.C.
Savannah, Georgia, 31405
United States
Baptist Healthcare System, Inc.
Louisville, Kentucky, 40207
United States
Hematology Oncology Clinic
Baton Rouge, Louisiana, 70809
United States
Tulane Cancer Center Office of Clinical Research
New Orleans, Louisiana, 70112
United States
American Oncology Partners of Maryland, PA
Bethesda, Maryland, 20817
United States
TidalHealth Peninsula Regional, Inc.
Salisbury, Maryland, 21801
United States
St. Vincent Frontier Cancer Center
Billings, Montana, 59102
United States
Westchester Medical Center
Hawthorne, New York, 10532
United States
Novant Cancer Institute Charlotte
Charlotte, North Carolina, 28204
United States
The James Cancer Hospital
Columbus, Ohio, 43210
United States
Cancer Care Associates of York
York, Pennsylvania, 17403
United States
Lifespan Cancer Institute
Providence, Rhode Island, 02903
United States
Prisma Health Cancer Institute
Greenville, South Carolina, 29615
United States
Sarah Cannon Research Institute SCRI
Chattanooga, Tennessee, 37404
United States
Kelsey Research Foundation
Houston, Texas, 77025
United States
Houston Methodist Hospital Cancer Center
Houston, Texas, 77030
United States
Lumi Research
Kingwood, Texas, 77339
United States
Baylor Scott & White Health
Round Rock, Texas, 78665
United States
Virginia Cancer Institute
Richmond, Virginia, 23228
United States
Summit Cancer Treatment Center
Spokane, Washington, 99208
United States
MultiCare Health System Institute for Research and Innovation
Spokane, Washington, 99218
United States

Collaborators and Investigators

Sponsor: Loxo Oncology, Inc.

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-22
Study Completion Date2028-01

Study Record Updates

Study Start Date2022-07-22
Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

  • BTKi
  • Hematologic Disease
  • Lymphoma, non-Hodgkin's
  • Lymphoma, B-cell

Additional Relevant MeSH Terms

  • Chronic Lymphocytic Leukemia
  • Leukemia, Lymphocytic
  • Leukemia, B-cell
  • Small Lymphocytic Lymphoma