A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Sponsor: Loxo Oncology, Inc.
ClinicalTrials ID:NCT06588478
This clinical trial evaluates the efficacy and safety of three dose levels of Pirtobrutinib, administered orally, in participants with relapsed or refractory CLL/SLL. Eligible participants must have received 1-3 prior treatments, including a covalent BTK inhibitor, and meet iwCLL 2018 criteria. Participants should have an ECOG score of 0-2 and be able to swallow oral medication.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The main purpose of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have received 1-3 lines of treatment including a covalent Bruton tyrosine kinase (BTK) inhibitor. The study is expected to last approximately 3 years.
Eligibility Criteria
Inclusion Criteria
- Have confirmed diagnosis of CLL/SLL as defined by these iwCLL 2018 criteria.
- 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
- 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.
Exclusion Criteria
-
Have received prior treatment with a BTK degrader and 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
-
Previous or concurrent cancer distinct from CLL/SLL within 3 years before randomization. Exceptions may occur with documented sponsor approval. Examples include:
- nonmelanoma skin cancer or lentigo maligna 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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Ironwood Cancer & Research Centers | 85224 | Chandler | Arizona |
| City of Hope National Medical Center | 91010 | Duarte | California |
| City of Hope National Medical Center | 92618 | Irvine | California |
| Palo Alto Medical Foundation Research Institute (PAMFRI) | 94304 | Palo Alto | California |
| Stanford Cancer Center | 94304 | Palo Alto | California |
| Rocky Mountain Cancer Center | 80012 | Aurora | Colorado |
| University of Miami Hospital and Clinics, Sylvester Cancer Center | 33136 | Miami | Florida |
| Mission Cancer + Blood | 50309 | Des Moines | Iowa |
| Saint Elizabeth Medical Center Edgewood | 41017 | Edgewood | Kentucky |
| American Oncology Partners of Maryland, PA | 20817 | Bethesda | Maryland |
Get This Program In Your Inbox
You can sign up and apply your patients for this program.
