A Study of Bosmolisib (BR101801) in Participants With R/R PTCL.

Официальное название

A Phase II, Single-arm, Multicenter, Open Label Study to Evaluate Efficacy and Safety of BR101801 Monotherapy in Relapsed/Refractory Peripheral T-cell Lymphoma Patients

Обзор

The objective of this phase II study is to evaluate the efficacy and safety of BR101801 in patients with peripheral T-cell lymphoma(PTCL).

Подробное описание

This phase II study will evaluate the efficacy and safety of single-dose BR101801 once daily in patients with peripheral T-cell lymphoma.

Вмешательства

• Препарат BR101801
  Patients will receive 200mg capsules (100mg+100mg)

Первичные конечные точки

• Confirmed Objective Response Rate (ORR) (CR + PR) assessed by a blinded independent reviewer at the central lab according to the 2014 Lugano criteria [Срок оценки: Up to 2 years]

Вторичные конечные точки (10)

• Objective Response Rate (ORR) (CR + PR) assessed by a blinded independent reviewer at the central lab according to the 2014 Lugano criteria [Срок оценки: Up to 2 years]
• Overall Survival (OS) [Срок оценки: Up to 2 years]
• Disease Control Rate (DCR) [Срок оценки: Up to 2 years]
• Duration of Response (DOR) [Срок оценки: Up to 2 years]
• Progression-free Survival (PFS) [Срок оценки: Up to 2 years]
• Time to Tumor Progression (TTP) [Срок оценки: Up to 2 years]
• Quality of life assessment Using the EQ-5D-5L assessment [Срок оценки: Every 2 cycles for up to 24 months (each cycle is 28 days)]
• Quality of life assessment Using EORTC QLQ-C30 assessment [Срок оценки: Every 2 cycles for up to 24 months (each cycle is 28 days)]
• Plasma Concentration of BR101801 (Bosmolisib) [Срок оценки: Cycle 2 Day 1 and Day 1 of Cycle 3 (each cycle is 28 days)]
• Adverse events [Срок оценки: Approximately 24 months after a consent to the participation]

Критерии участия

Критерии включения

• The ECOG performance status ≤ 2.
• Life expectancy more than 3 months.
• Patients with relapsed and/or refractory to standard therapy or are intolerance to standard therapy diagnosed with 2022 World Health Organization (WHO) classification

• Peripheral T-cell lymphoma, not otherwise specified
• Nodal TFH cell lymphoma, angioimmunoblastic-type
• Nodal TFH cell lymphoma, follicular-type
• Nodal TFH cell lymphoma, NOS
• Patients currently requiring systemic therapy at the investigator's discretion.
• Patients with a lesion measuring 1.5 cm or more in its longest transverse diameter, as determined by CT, PET/CT or MRI scans according to the 2014 Lugano criteria.

Критерии исключения

• The presence of overt leptomeningeal or active central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy or increasing doses of corticosteroids within the prior 2 weeks.
• Impaired cardiac function or clinically significant cardiac disease.
• Patients with interstitial pneumonia or history of drug-induced interstitial pneumonia/pneumonitis.
• For patients with lymphoma:

• Systemic antineoplastic therapy (including cytotoxic chemotherapy, alfa-interferon \[INF\], and toxin immunoconjugates) or any experimental therapy within 3 weeks or 5 half lives, whichever is shorter, before the first dose of study treatment.
• Therapy with tyrosine kinase inhibitor within 5 half-lives before the first dose of study treatment.
• Unconjugated monoclonal antibody therapies < 6 weeks before the first dose of study treatment.
• Patients receiving systemic chronic steroid therapy or any immunosuppressive therapy (>20 mg/day prednisone or equivalent).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07180771 · BR-101801-CT-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗