Recruiting

Phase 2

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

Sponsor:

Loxo Oncology, Inc.

Code:

NCT06588478

Conditions

Chronic Lymphocytic Leukemia

Small Lymphocytic Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pirtobrutinib

Study Details

Brief summary:

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

Chronic Lymphocytic Leukemia

Small Lymphocytic Lymphoma

Study ID

NCT06588478

Start date

Jan 3, 2025

Status verified date

May, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

249 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Pirtobrutinib Standard Dose (Dose 1)-Part 1

Pirtobrutinib administered orally.

experimental: Pirtobrutinib Dose 2-Part 1

Pirtobrutinib administered orally.

experimental: Pirtobrutinib Dose 3-Part 1

Pirtobrutinib administered orally.

experimental: Pirtobrutinib Standard Dose-Part 2

Pirtobrutinib administered orally.

Interventions

Pirtobrutinib

Administered Orally.

Primary outcome measure

Overall Response Rate [ Time Frame: Baseline up to 3 years ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Ironwood Cancer & Research Centers

Recruiting

Chandler, Arizona, United States, 85224

Principal Investigator:

Michael Musci

City of Hope National Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

800-826-4673

Principal Investigator:

Alexey Danilov

City of Hope National Medical Center

Recruiting

Irvine, California, United States, 92618

Contacts

626-218-2405

Principal Investigator:

Alexey Danilov

Palo Alto Medical Foundation Research Institute (PAMFRI)

Recruiting

Palo Alto, California, United States, 94304

Principal Investigator:

Roozbeh Mohajer

Stanford Cancer Center

Recruiting

Palo Alto, California, United States, 94304

Principal Investigator:

Bita Fakhri

Rocky Mountain Cancer Center

Recruiting

Aurora, Colorado, United States, 80012

Contacts

303-418-7639

Principal Investigator:

John Burke

University of Miami Hospital and Clinics, Sylvester Cancer Center

Recruiting

Miami, Florida, United States, 33136

Principal Investigator:

Alvaro Alencar

City of Hope National Medical Center, Atlanta Cancer Center

Recruiting

Newnan, Georgia, United States, 30265

Principal Investigator:

Sabarish Ayyappan

Mission Cancer + Blood

Recruiting

Waukee, Iowa, United States, 50263

Contacts

515-282-2921

Principal Investigator:

Tara Graff

Saint Elizabeth Medical Center Edgewood

Recruiting

Edgewood, Kentucky, United States, 41017

Principal Investigator:

Miguel Islas-Ohlmayer

American Oncology Partners, PA

Recruiting

Bethesda, Maryland, United States, 20817

Contacts

301-571-2016

Principal Investigator:

Victor Priego

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Principal Investigator:

Andrew Wilks

Gulfport Memorial Hospital

Recruiting

Gulfport, Mississippi, United States, 39501

Contacts

228-575-1234

Principal Investigator:

Pamela Tuli

Comprehensive Cancer Centers of Nevada

Recruiting

Henderson, Nevada, United States, 89074

Principal Investigator:

Anthony Nguyen

East Carolina University

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

252-744-1015

Principal Investigator:

Darla Liles

Williamette Valley Cancer Institute & Research Center

Recruiting

Eugene, Oregon, United States, 97401

Contacts

541-683-5001

Principal Investigator:

Jeff Sharman

Cancer Care Associates Of York

Recruiting

York, Pennsylvania, United States, 17403

Contacts

717-741-9229

Principal Investigator:

Jackson Gao

The West Clinic, PLLC dba West Cancer Center

Recruiting

Germantown, Tennessee, United States, 38138

Contacts

901-683-0055

Principal Investigator:

Jason Chandler

USO-Texas Oncology-Central/South Texas

Recruiting

Austin, Texas, United States, 78705

Contacts

512-421-4100

Principal Investigator:

Jason Melear

Sarah Cannon Research Institute/SCRI

Recruiting

The Woodlands, Texas, United States, 77380

Contacts

999-999-9999

Principal Investigator:

SMO Sarah Cannon Research Inst.

USO-Virginia Oncology Associates

Recruiting

Hampton, Virginia, United States, 23666

Contacts

757-368-0437

Principal Investigator:

Celesteann Bremer

Royal Victoria Regional Health Centre

Recruiting

Barrie, Canada, L4M 6M2

Principal Investigator:

Derek Nay

Saskatoon Cancer Centre

Recruiting

Saskatoon, Canada, S7N4H4

Principal Investigator:

Julie Stakiw

More Information

Sponsor

Loxo Oncology, Inc.

Last update posted

May 19, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Loxo Oncology, Inc. on 2026-05-19.