Chronic Lymphocytic Leukemia study: Pirtobrutinib vs Ibrutinib
Official title A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
ClinicalTrials.gov ID: NCT05254743
What this study is testing
What is Pirtobrutinib?
An investigational oral medicine being studied as a potential treatment for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It is designed to reversibly inhibit Bruton's tyrosine kinase (BTK), a protein that helps cancer cells grow and survive.
Also referred to as LOXO-305, LY3527727.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see how well and how safely pirtobrutinib works compared to ibrutinib. In a second part it will test pirtobrutinib alone in patients who have not yet been treated and have a specific genetic change (17p deletion).
- Who it's for
- Adults with chronic lymphocytic leukemia or small lymphocytic lymphoma, whether or not they have had previous treatment.
- What's involved
- Participants will receive either pirtobrutinib or ibrutinib and will have regular clinic visits and medical tests to monitor the drug’s effects and any side‑effects.
- Time commitment
- The first part of the study can last up to six years, while the second part can last up to two years, with scheduled visits throughout.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
- Part 1 - Known 17p deletion status (wildtype or deleted). Part 2 - Must have deletion of 17p as determined by FISH testing
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Adequate organ function
- 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...
You likely can't join if
- Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time...
- 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 including ejection fraction \< 40% and any grade ongoing atrial fibrillation or atrial flutter
- Hepatitis B or hepatitis C testing indicating active/ongoing infection, based on Screening laboratory tests
See the full eligibility criteria
- Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
- Part 1 - Known 17p deletion status (wildtype or deleted). Part 2 - Must have deletion of 17p as determined by FISH testing
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Adequate organ function
- 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,
- Hemoglobin ≥8 grams/deciliter (g/dL) or ≥6 g/dL in participants with documented bone marrow involvement considered to impair hematopoiesis
- Absolute neutrophil count ≥0.75 x 10⁹/L or ≥0.50 × 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis
- Kidney function: Estimated creatinine clearance ≥30 milliliters per minute (mL/min)
- 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 including ejection fraction \< 40% and any grade ongoing atrial fibrillation or atrial flutter
- Hepatitis B or hepatitis C testing indicating active/ongoing infection, based on Screening laboratory tests
- 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
- Previous treatment for CLL/SLL - Part 1: Treatment-naïve and previously treated, except prior exposure to BTK inhibitor (covalent or noncovalent). Part 2: participants must be treatment naïve
- 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...
- Participants with known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or ibrutinib
The study team makes the final eligibility decision.
Where it is enrolling
- Anaheim, California, United States
- Cerritos, California, United States
- Palo Alto, California, United States
- Fort Myers, Florida, United States
- Saint Augustine, Florida, United States
- West Palm Beach, Florida, United States
- Bethesda, Maryland, United States
- Billings, Montana, United States
- Nashville, Tennessee, United States
- Kingwood, Texas, United States
- Richmond, Virginia, United States
- Spokane, Washington, United States
- Ciudad Autónoma de Buenos Aire, Argentina
- Santa Fe, Argentina
- West Perth, Australia
- Leuven, Belgium
- Sint-Niklaas, Belgium
- Barretos, Brazil
- Botucatu, Brazil
- Campinas, Brazil
+ 63 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Anaheim, California, United States; Cerritos, California, United States; Palo Alto, California, United States; Fort Myers, Florida, United States; Saint Augustine, Florida, United States; West Palm Beach, Florida, United States and 77 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.