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Purpose

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.

Conditions

Eligibility

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

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
Part 2 is non-randomized

Arm Groups

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.