Evaluating Pirtobrutinib for patients with relapsed or refractory CLL/SLL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study assesses the efficacy and safety of Pirtobrutinib at three different dose levels in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Participants must have received 1 to 3 prior lines of treatment, including a covalent Bruton tyrosine kinase (BTK) inhibitor. The study aims to determine how well this medication works over approximately three years.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

* 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 it's running

• Ironwood Cancer & Research Centers
  Chandler, Arizona, United States Recruiting
• City of Hope National Medical Center
  Duarte, California, United States Recruiting
• City of Hope National Medical Center
  Irvine, California, United States Recruiting
• Palo Alto Medical Foundation Research Institute (PAMFRI)
  Palo Alto, California, United States Recruiting
• Stanford Cancer Center
  Palo Alto, California, United States Recruiting
• Rocky Mountain Cancer Center
  Aurora, Colorado, United States Recruiting

+79 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• NX-5948 vs Pirtobrutinib in R/R CLL/SLL

  This study tests NX-5948 against pirtobrutinib in people with relapsed or refractory CLL/SLL who have previously tried a covalent BTK inhibitor.

  Recruiting at 6 sites Phase 3 Nurix Therapeutics, Inc. · Macon, Georgia and 5 other locations · NCT07516093

• Comparing a BTK-targeted protein degrader (BGB-16673) with pirtobrutinib for adults with relapsed or refractory CLL or SLL

  This trial tests whether BGB-16673 works better and is as safe as pirtobrutinib for adults whose CLL or SLL has come back or not responded after prior covalent BTK inhibitor treatment.

  Recruiting at 217 sites Phase 3 BeOne Medicines · Birmingham, Alabama and 216 other locations · NCT06973187

• Combining pirtobrutinib and venetoclax for treating resistant CLL or SLL

  This study is testing if combining two drugs, pirtobrutinib and venetoclax, can help people with chronic lymphocytic leukemia or small lymphocytic lymphoma that hasn’t responded to previous treatments.

  Recruiting Phase 2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT06466122

• Fixed-duration treatment for chronic lymphocytic leukemia with pirtobrutinib and obinutuzumab

  This study is testing a year-long treatment combining two medications, pirtobrutinib and obinutuzumab, to see if it helps people with chronic lymphocytic leukemia feel better.

  Recruiting at 4 sites Phase 2 Dana-Farber Cancer Institute · Scarborough, Maine and 3 other locations · NCT06333262

• Pirtobrutinib versus ibrutinib for people with CLL or SLL.

  This trial will test whether pirtobrutinib works better or is safer than ibrutinib for adults with CLL/SLL, with a separate part that tries pirtobrutinib alone in treatment‑naïve patients who have a 17p deletion.

  Recruiting at 93 sites Phase 3 Eli Lilly and Company · Anaheim, California and 142 other locations · NCT05254743

• Venetoclax plus Zanubrutinib for CLL/SLL in frontline or previously treated patients

  This phase II trial tests if venetoclax plus zanubrutinib can safely and effectively treat adults with chronic lymphocytic leukemia or small lymphocytic lymphoma, including those who are newly diagnosed and those who have had prior therapy.

  Recruiting Phase 2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07734038

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.