RecruitingPhase 1NCT04215809

Study of APG-2575 as a Single Agent or in Combination With Other Therapeutic Agents for CLL/SLL

APG-2575CU101, A Phase Ib 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)


Sponsor

Ascentage Pharma Group Inc.

Enrollment

144 participants

Start Date

Mar 2, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

Assess the safety and tolerability, identify dose-limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D) of lisaftoclax.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called lisaftoclax (APG-2575) alone or in combination with other cancer drugs (including acalabrutinib, obinutuzumab, or venetoclax) in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has returned or stopped responding to treatment. **You may be eligible if...** - You are 18 or older - You have CLL or SLL confirmed by diagnosis that has relapsed or is not responding to at least one prior therapy - Your disease shows signs of progression (rising white blood cell counts, enlarging lymph nodes or spleen) - Your general health is adequate (ECOG 0–2) - Treatment-naive patients may also be eligible for the lisaftoclax plus acalabrutinib combination **You may NOT be eligible if...** - You have not had at least one prior line of therapy for CLL/SLL (except for certain combination cohorts) - Your organ function is too impaired for treatment - You do not have documented disease progression Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLisaftoclax

Lisaftoclax investigation drug in ramp up dosing


Locations(9)

City of Hope

Duarte, California, United States

Mayo Clinic

Jacksonville, Florida, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Novant Health

Charlotte, North Carolina, United States

Gabrail Cancer Center

Canton, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Swedish Health

Seattle, Washington, United States

Princess Alexandria Hospital

Brisbane, Queensland, Australia

Frankston Private Hospital

Melbourne, Victoria, Australia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04215809


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