A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

What this study is about

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.

Who can join (things the study team will check)

✅ 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
  • 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.

🚫 You may not be able to 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
• 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 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

Where this trial is running

• Ironwood Cancer & Research Centers, Chandler, Arizona, United States
• City of Hope National Medical Center, Duarte, California, United States
• City of Hope National Medical Center, Irvine, California, United States
• Palo Alto Medical Foundation Research Institute (PAMFRI), Palo Alto, California, United States
• Stanford Cancer Center, Palo Alto, California, United States
• Rocky Mountain Cancer Center, Aurora, Colorado, United States
• University of Miami Hospital and Clinics, Sylvester Cancer Center, Miami, Florida, United States
• City of Hope National Medical Center, Atlanta Cancer Center, Newnan, Georgia, United States
• Mission Cancer + Blood, Waukee, Iowa, United States
• Saint Elizabeth Medical Center Edgewood, Edgewood, Kentucky, United States
• American Oncology Partners, PA, Bethesda, Maryland, United States
• Boston Medical Center, Boston, Massachusetts, United States

+ 119 more sites.

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 1-317-615-4559 · LillyTrials@Lilly.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06588478.