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Clinical Trials in the USA / NCT06588478
Recruiting Phase 2

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

NCT06588478 · tracked via the Priya Life Science USA tracker
Sponsor
Loxo Oncology, Inc.
Phase
Phase 2
Started
2025-01-03
Last updated
2026-05-19

Condition(s) studied

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Investigational drug(s) / intervention(s)

Pirtobrutinib

Pirtobrutinib: Administered Orally.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

Trial sites (131)

FacilityCityRegionStatus
Ironwood Cancer & Research Centers Chandler Arizona Recruiting
City of Hope National Medical Center Duarte California Recruiting
City of Hope National Medical Center Irvine California Recruiting
Palo Alto Medical Foundation Research Institute (PAMFRI) Palo Alto California Recruiting
Stanford Cancer Center Palo Alto California Recruiting
Rocky Mountain Cancer Center Aurora Colorado Recruiting
University of Miami Hospital and Clinics, Sylvester Cancer Center Miami Florida Recruiting
City of Hope National Medical Center, Atlanta Cancer Center Newnan Georgia Recruiting
Mission Cancer + Blood Waukee Iowa Recruiting
Saint Elizabeth Medical Center Edgewood Edgewood Kentucky Recruiting
American Oncology Partners, PA Bethesda Maryland Recruiting
Boston Medical Center Boston Massachusetts Recruiting
Gulfport Memorial Hospital Gulfport Mississippi Recruiting
Comprehensive Cancer Centers of Nevada Henderson Nevada Recruiting
East Carolina University Greenville North Carolina Recruiting
Williamette Valley Cancer Institute & Research Center Eugene Oregon Recruiting
Cancer Care Associates Of York York Pennsylvania Recruiting
The West Clinic, PLLC dba West Cancer Center Germantown Tennessee Recruiting
USO-Texas Oncology-Central/South Texas Austin Texas Recruiting
Sarah Cannon Research Institute/SCRI The Woodlands Texas Recruiting
USO-Virginia Oncology Associates Hampton Virginia Recruiting
Flinders Medical Centre Adelaide Australia Recruiting
Bankstown-Lidcombe Hospital Bankstown Australia Recruiting
Box Hill Hospital Box Hill Australia Recruiting
Coffs Harbour Health Campus Coffs Harbour Australia Recruiting
Royal Hobart Hospital Hobart Australia Recruiting
ICON Cancer Centre - Kurralta Park Kurralta Park Australia Recruiting
Latrobe Regional Health Traralgon Australia Recruiting
Calvary Mater Newcastle Waratah Australia Recruiting
The Perth Blood Institute - West Perth West Perth Australia Recruiting
Princess Alexandra Hospital Woolloongabba Australia Recruiting
Institut Jules Bordet Anderlecht Belgium Recruiting
AZ Sint-Jan Brugge-Oostende AV Bruges Belgium Recruiting
UZ Gent Ghent Belgium Recruiting
Groupe Jolimont La Louvière Belgium Recruiting
UZ Leuven Leuven Belgium Recruiting
Clinique Saint Pierre Ottignies Belgium Recruiting
AZ Delta vzw Roeselare Belgium Recruiting
AZ Nikolaas Sint-Niklaas Belgium Recruiting
CHR Verviers - La Tourelle Verviers Belgium Recruiting

+ 91 more sites — see the full list on the official registry below.

More Loxo Oncology, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06588478 on ClinicalTrials.gov ↗ ← All trials in the USA