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

Purpose

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.

Conditions

  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Pirtobrutinib Standard Dose (Dose 1) 		Pirtobrutinib administered orally.
  • Drug: Pirtobrutinib
    Administered Orally.
Experimental
Pirtobrutinib Dose 2 		Pirtobrutinib administered orally.
  • Drug: Pirtobrutinib
    Administered Orally.
Experimental
Pirtobrutinib Dose 3 		Pirtobrutinib administered orally.
  • Drug: Pirtobrutinib
    Administered Orally.

Recruiting Locations

Boston Medical Center
Boston, Massachusetts 02118

More Details

Status
Recruiting
Sponsor
Loxo Oncology, Inc.

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
clinical_inquiry_hub@lilly.com