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Активно (без набиране) Фаза 2 2024-515654-25-00

A Phase Ib/II Study of APG-2575 as a Single Agent or in Combination with Other Therapeutic Agents in Patients with Relapsed and/or Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (SACRED).

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Relapsed and/or Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL).

Спонсор: Ascentage Pharma Group Inc.

Налично на: БГ
Обобщение
Trial status: Authorised Secondary endpoints include determining the effectiveness of APG-2575 as monotherapy and in combination with other anticancer agents in patients with relapsed and/or refractory CLL by determining ORR (CR and PR) and MRD negativity. Primary endpoints include characterizing safety and tolerability, defining the MTD and recommended phase 2 dose (RP2D).
Описание
Secondary endpoints include determining the effectiveness of APG-2575 as monotherapy and in combination with other anticancer agents in patients with relapsed and/or refractory CLL by determining ORR (CR and PR) and MRD negativity.
Кой може да участва
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 60 participants
Интервенции
Calquence 100 mg hard capsules
Drug
IMBRUVICA 420 mg film-coated tablets
Drug
IMBRUVICA 140 mg hard capsules
Drug
IMBRUVICA 140 mg hard capsules
Drug
BRUKINSA 80 mg hard capsules
Drug
Lisaftoclax
Drug
Calquence 100 mg hard capsules
Drug
MabThera 500 mg concentrate for solution for infusion
Drug
Lisaftoclax
Drug
Lisaftoclax
Drug
Места на провеждане 2
Унгария (1)
Полша (1)
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
17.09.2024
Регистрационен номер
2024-515654-25-00
Източник
euclinicaltrials.eu
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