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Набира участници Фаза 2 NCT06588478

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

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Спонсор: Loxo Oncology, Inc.

Налично на: БГ
Обобщение
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.
Кой може да участва
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
Места на провеждане 17
Австралия (1)
Flinders Medical Centre
Adelaide
Белгия (1)
Institut Jules Bordet
Anderlecht
Канада (1)
Royal Victoria Regional Health Centre
Barrie
Чехия (1)
Fakultní nemocnice Brno Bohunice
Brno
Дания (1)
Aarhus Universitetshospital, Skejby
Aarhus
Франция (1)
Centre Hospitalier d'Argenteuil Victor Dupouy
Argenteuil
Гърция (1)
Evangelismos General Hospital of Athens
Athens
Унгария (1)
Semmelweis Egyetem
Budapest
Италия (1)
A.O.U.C. Policlinico di Bari
Bari
Полша (1)
IN VIVO
Bydgoszcz
Румъния (1)
Fundeni Clinical Institute
Bucharest
Словакия (1)
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
Banská Bystrica
Южна Корея (1)
Pusan National University Hospital
Busan
Испания (1)
Institut Català d'Oncologia (ICO) - Badalona
Badalona
Турция (1)
Sakarya University School of Medicine
Adapazarı
Великобритания (1)
Heartlands Hospital
Birmingham
САЩ (1)
Ironwood Cancer & Research Centers
Chandler , Arizona
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
03.01.2025
Крайна дата
01.12.2028
Регистрационен номер
NCT06588478
Източник
anzctr
Запитване за медицински туризъм

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