Chronic Lymphocytic Leukemia study: Pirtobrutinib
Official title A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
ClinicalTrials.gov ID: NCT06588478
What this study is testing
What is Pirtobrutinib?
Pirtobrutinib is an investigational oral medicine being studied for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It is designed to inhibit Bruton tyrosine kinase (BTK) in the body.
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 looks at how well and how safely pirtobrutinib works at three different doses in patients whose CLL or SLL has come back or not responded after 1‑3 treatments, including a BTK inhibitor. It also checks the drug alone in patients who have never been treated and have a 17p deletion.
- Who it's for
- Adults with chronic lymphocytic leukemia or small lymphocytic lymphoma who have had 1‑3 prior treatments that included a BTK inhibitor, or adults who have never been treated and have a 17p deletion.
- What's involved
- Participants will take pirtobrutinib at one of three dose levels and will have regular clinic visits and medical tests to monitor the drug’s effects and any side‑effects.
- Time commitment
- Part 1 of the study lasts about 3 years, while Part 2 can last up to 2 years, with scheduled visits throughout the study period.
- Phase 2: a mid-size study of how well it works
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
- Have confirmed diagnosis of CLL/SLL as defined by iwCLL 2018 criteria.
- Part 1: Have received prior CLL/SLL treatment
- Have received at least 1, but not more than 3 lines of prior treatment for CLL/SLL
- Have received a covalent BTK inhibitor
- Part 2: Have received no prior treatment for CLL/SLL
You likely can't join if
- Have received prior treatment with a BTK degrader or a noncovalent BTK inhibitor
- Have a history of greater than or equal to (\>=) Grade 3 bleeding due to treatment with a BTK inhibitor
- Have known or suspected Richter's transformation
- Have known or suspected history of central nervous system involvement by CLL/SLL
- nonmelanoma skin cancer or lentigo malignant melanoma
- cervical carcinoma in situ
See the full eligibility criteria
- Have confirmed diagnosis of CLL/SLL as defined by iwCLL 2018 criteria.
- Part 1: Have received prior CLL/SLL treatment
- Have received at least 1, but not more than 3 lines of prior treatment for CLL/SLL
- Have received a covalent BTK inhibitor
- Part 2: Have received no prior treatment for CLL/SLL
- Part 1 - Known 17p deletion status (positive or negative)
- Part 2 - Must have 17p deletion (positive)
- Have a requirement for therapy consistent with iwCLL 2018 criteria for initiation of therapy
- Capable of swallowing oral study medication.
- Have an Eastern Cooperative Oncology Group Performance Status (ECOG) score of 0 to 2.
- Have received prior treatment with a BTK degrader or a noncovalent BTK inhibitor
- Have a history of greater than or equal to (\>=) Grade 3 bleeding due to treatment with a BTK inhibitor
- Have known or suspected Richter's transformation
- Have known or suspected history of central nervous system involvement by CLL/SLL
- nonmelanoma skin cancer or lentigo malignant melanoma
- cervical carcinoma in situ
- localized prostate cancer undergoing active surveillance, and
- localized (for example, lymph node negative) breast cancer with no evidence of active disease present for more than 3 years. Individual may be receiving adjuvant hormonal therapy
The study team makes the final eligibility decision.
Where it is enrolling
- Chandler, Arizona, United States
- Duarte, California, United States
- Irvine, California, United States
- Palo Alto, California, United States
- Aurora, Colorado, United States
- Miami, Florida, United States
- Newnan, Georgia, United States
- Waukee, Iowa, United States
- Edgewood, Kentucky, United States
- Bethesda, Maryland, United States
- Boston, Massachusetts, United States
- Gulfport, Mississippi, United States
- Henderson, Nevada, United States
- Greenville, North Carolina, United States
- Eugene, Oregon, United States
- York, Pennsylvania, United States
- Austin, Texas, United States
- The Woodlands, Texas, United States
- Hampton, Virginia, United States
- Adelaide, Australia
+ 92 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 Chandler, Arizona, United States; Duarte, California, United States; Irvine, California, United States; Palo Alto, California, United States; Aurora, Colorado, United States; Miami, Florida, United States and 106 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.