A Phase 2, Open-Label, Randomized Study Evaluating the Efficacy and Safety of 3 Doses of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Who Previously Received Treatment With a Covalent Bruton Tyrosine Kinase Inhibitor
Summary
The main purpose of Part 1 of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with 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 purpose of Part 2 of this study is to evaluate pirtobrutinib monotherapy in participants with treatment-naïve CLL/SLL with 17p deletions. Participation in Part 1 is expected to last approximately 3 years. Participation in Part 2 is expected to last up to 2 years.
Arms & interventions
- DrugPirtobrutinib
Administered Orally.
Outcome measures
Primary
Overall Response Rate
Overall response rate is defined as the proportion of participants who achieve the best overall response at or before the initiation of subsequent anticancer therapy of CR, CRi, nPR, or PR. ORR will be assessed using International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 response criteria.
Time frame: Baseline up to 3 years
Secondary
Duration of Response
Time frame: Baseline up to 3 years
Eligibility criteria
Study locations (21)
Ironwood Cancer & Research Centers
Chandler, Arizona, 85224
City of Hope National Medical Center
Duarte, California, 91010
City of Hope National Medical Center
Irvine, California, 92618
Palo Alto Medical Foundation Research Institute (PAMFRI)
Palo Alto, California, 94304
Stanford Cancer Center
Palo Alto, California, 94304
Rocky Mountain Cancer Center
Aurora, Colorado, 80012
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, 33136
City of Hope National Medical Center, Atlanta Cancer Center
Newnan, Georgia, 30265
Mission Cancer + Blood
Waukee, Iowa, 50263
Saint Elizabeth Medical Center Edgewood
Edgewood, Kentucky, 41017
American Oncology Partners, PA
Bethesda, Maryland, 20817
Boston Medical Center
Boston, Massachusetts, 02118
Gulfport Memorial Hospital
Gulfport, Mississippi, 39501
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89074
East Carolina University
Greenville, North Carolina, 27834
Williamette Valley Cancer Institute & Research Center
Eugene, Oregon, 97401
Cancer Care Associates Of York
York, Pennsylvania, 17403
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee, 38138
USO-Texas Oncology-Central/South Texas
Austin, Texas, 78705
Sarah Cannon Research Institute/SCRI
The Woodlands, Texas, 77380
USO-Virginia Oncology Associates
Hampton, Virginia, 23666