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

Status
Active
Cancer Type
Hematopoietic Malignancies
Unknown Primary
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06588478
Protocol IDs
18877 (primary)
NCI-2025-02626
2024-515689-15-00
J2N-MC-JZNX
Study Sponsor
Loxo Oncology, Inc.

Summary

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

  1. Have confirmed diagnosis of CLL/SLL as defined by these iwCLL 2018 criteria.
  2. Have received prior CLL/SLL treatment
  3. Have received at least 1, but not more than 3 lines of prior treatment for CLL/SLL
  4. Have received a covalent BTK inhibitor
  5. Have a requirement for therapy consistent with iwCLL 2018 criteria for initiation of therapy
  6. Capable of swallowing oral study medication.
  7. Have an Eastern Cooperative Oncology Group Performance Status (ECOG) score of 0 to 2.

Treatment Sites in Georgia

City of Hope Atlanta


600 Celebrate Life Parkway
Newnan, GA 30265
770-400-6169
www.cityofhope.org/locations/atlanta/atlanta-cancer-center

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.