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Recruiting NCT07218341

A Study of Pirtobrutinib (LY3527727) in Participants With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Phase IV Interventional Chronic Lymphocytic Leukemia Lymphoma, Small Lymphocytic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pirtobrutinib, Idelalisib.
Who it may be relevant to
Registry conditions: Chronic Lymphocytic Leukemia, Lymphoma, Small Lymphocytic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Austria, Belgium, Canada +11
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Long-Term Safety of Pirtobrutinib in Participants From Study LOXO-BTK-20020 With BTKi Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Overview

This study will evaluate the long-term safety of pirtobrutinib in participants with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study is open to those who completed J2N-MC-JZNN/LOXO-BTK-20020 (NCT 04666038) for continued access to the study intervention or continued follow-up visits. Treatment will be given every 4 weeks and this study is expected to last about 5 years.

Interventions

  • Drug Pirtobrutinib
    Administered orally
  • Drug Idelalisib
    Administered orally

Primary outcome measures

  • Percentage of Participants with a Grade 3 or Higher Treatment-emergent Adverse Events (AEs) [Time frame: Time from First Dose of Study Intervention (Study Day 1) through 30 Days After Last Dose of Study Intervention or Start of New Anticancer Therapy, whichever is Earlier]
Secondary outcome measures (1)
  • Overall Survival [Time frame: Time from Enrollment in the Originator Study until Death from Any Cause (Up to 93 Months)]

Eligibility criteria

Inclusion criteria

  • Are actively participating in study J2N-MC-JZNN/LOXO-BTK-20020

Exclusion criteria

  • This is not applicable to this study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 13 centers
  • Xuanwu Hospital Capital Medical University — Beijing
  • Hunan Cancer Hospital — Changsha
  • Sun Yat-sen University Cancer Center — Guangdong
  • Nanfang Hospital of Southern Medical University — Guangzhou
  • Gansu Provincial Cancer Hospital — Lanzhou
  • The First Affiliated Hospital of Nanchang University — Nanchang
  • Fudan University Shanghai Cancer Center — Shanghai
  • Taizhou Hospital of Zhejiang Province — Taizhou
  • … and 5 more centers
United States · 9 centers
  • Mitchell Cancer Institute — Mobile
  • Arizona Oncology Associates, P.C. - HOPE — Tucson
  • Cancer Specialists, LLC — Jacksonville
  • Minnesota Oncology Hematology, P.A. — Coon Rapids
  • Cayuga Cancer Center — Ithaca
  • Memorial Sloan-Kettering Cancer Center (MSKCC) - New York — New York
  • Oncology Hematology Care Inc — Cincinnati
  • Texas Oncology - Paris — Fort Worth
  • … and 1 more center
Italy · 7 centers
  • Azienda Ospedaliero - Universitaria Nazionale Santi Antonio e Biagio e Cesare Arrigo — Alessandria
  • Azienda Ospedaliera Universitaria Careggi — Florence
  • Presidio Ospedaliero Papardo — Messina
  • Fondazione IRCCS San Gerardo dei Tintori — Monza
  • Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia — Perugia
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome
  • Azienda Ospedaliera S. Maria Di Terni — Terni
Poland · 3 centers
  • Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im.ks.B.Markiewicza — Brzozów
  • Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy — Bydgoszcz
  • Pratia Onkologia Katowice — Katowice
United Kingdom · 3 centers
  • Castle Hill Hospital — Hull
  • St James's University Hospital — Leeds
  • GenesisCare — Newmarket
Hungary · 2 centers
  • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet — Budapest
  • Debreceni Egyetem — Debrecen
Ireland · 2 centers
  • St. James's Hospital — Dublin
  • Beaumont Hospital — Dublin
Spain · 2 centers
  • Hospital Universitario Marques De Valdecilla — Santander
  • Hospital Universitario Virgen Del Rocio — Seville
Australia · 1 center
  • The Alfred Hospital — Melbourne
Austria · 1 center
  • LKH - Universitätsklinikum der PMU Salzburg — Salzburg
Belgium · 1 center
  • AZ Delta — Roeselare
Canada · 1 center
  • Princess Margaret Cancer Centre - University Health Network — Toronto
Croatia · 1 center
  • University Hospital Center Zagreb — Zagreb
Czechia · 1 center
  • Fakultni nemocnice Hradec Kralove — Hradec Králové
France · 1 center
  • Centre Henri Becquerel — Rouen
Japan · 1 center
  • Tokai University Hospital — Isehara

Identifiers

NCT: NCT07218341 · 27296 · J2N-MC-JZ03 · J2N-MC-JZNY

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗