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Active (not recruiting) Phase 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).

Phase 2 – studying effectiveness and dosage
Conditions: Relapsed and/or Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL).

Sponsor: Ascentage Pharma Group Inc.

trial.available_in: БГ
Overview
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).
Description
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.
Who can participate
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 60 participants
Interventions
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
Locations 2
Hungary (1)
Poland (1)
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
17.09.2024
Registry ID
2024-515654-25-00
Source
euclinicaltrials.eu
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