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).

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515654-25-00

Acronym

APG-2575CU101

Enrollment

Registered

2024-09-17

Start date

2021-12-20

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed and/or Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL).

Brief summary

Primary endpoints include characterizing safety and tolerability, defining the MTD and recommended phase 2 dose (RP2D).

Detailed 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.

Interventions

DRUGBRUKINSA 80 mg hard capsules

DRUGIMBRUVICA 140 mg hard capsules

DRUGLisaftoclax

DRUGCalquence 100 mg hard capsules

DRUGMabThera 500 mg concentrate for solution for infusion

DRUGIMBRUVICA 420 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Primary endpoints include characterizing safety and tolerability, defining the MTD and recommended phase 2 dose (RP2D).	—

Secondary

Measure	Time frame
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.	—

Countries

Hungary, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026