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Recruiting Phase 2 NCT06588478

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

Phase 2 – studying effectiveness and dosage
Conditions: Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Sponsor: Loxo Oncology, Inc.

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Overview
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.
Who can participate
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
Locations 17
Australia (1)
Flinders Medical Centre
Adelaide
Belgium (1)
Institut Jules Bordet
Anderlecht
Canada (1)
Royal Victoria Regional Health Centre
Barrie
Czech Republic (1)
Fakultní nemocnice Brno Bohunice
Brno
Denmark (1)
Aarhus Universitetshospital, Skejby
Aarhus
France (1)
Centre Hospitalier d'Argenteuil Victor Dupouy
Argenteuil
Greece (1)
Evangelismos General Hospital of Athens
Athens
Hungary (1)
Semmelweis Egyetem
Budapest
Italy (1)
A.O.U.C. Policlinico di Bari
Bari
Poland (1)
IN VIVO
Bydgoszcz
Romania (1)
Fundeni Clinical Institute
Bucharest
Slovakia (1)
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
Banská Bystrica
South Korea (1)
Pusan National University Hospital
Busan
Spain (1)
Institut Català d'Oncologia (ICO) - Badalona
Badalona
Turkey (1)
Sakarya University School of Medicine
Adapazarı
United Kingdom (1)
Heartlands Hospital
Birmingham
United States (1)
Ironwood Cancer & Research Centers
Chandler , Arizona
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
03.01.2025
Completion date
01.12.2028
Registry ID
NCT06588478
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.