Study of APG-2575 with Azacitidine for Patients with Acute Myeloid Leukemia (AML)

Sponsor: Ascentage Pharma Group Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04964518

Provider View

This clinical trial is testing the safety and effectiveness of a new drug combination, APG-2575 and Azacitidine, for patients with certain types of leukemia that have not responded to previous treatments.

Patient Parameters

Program Overview

This study is exploring a new treatment for patients with specific types of leukemia, including acute myeloid leukemia (AML), mixed phenotype acute leukemia (MPAL), and chronic myelomonocytic leukemia (CMML), as well as higher-risk myelodysplastic syndromes (MDS). The trial is divided into two parts: the first part will determine the safest dose of the new drug combination, and the second part will expand the study to more patients to further evaluate its effectiveness.

Description

The trial is for patients whose leukemia has returned or has not responded to previous treatments. It involves a new drug combination of APG-2575 and Azacitidine. The study will start with a small group of patients to find the safest dose, and then more patients will be added to see how well the treatment works. Participants will receive the treatment and be monitored for side effects and improvements in their condition.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of relapsed or refractory acute myeloid leukemia (AML), mixed phenotype acute leukemia (MPAL), chronic myelomonocytic leukemia (CMML), or higher-risk myelodysplastic syndromes (MDS).
  • No standard treatments are available or expected to work for your condition.
  • MPAL includes various types of leukemia with multiple cell lineages.
  • For MDS, must have previously received at least four cycles of HMA therapy without success or have had the disease return after treatment.

Exclusion Criteria

  • Pregnant women.
  • Have uncontrolled health issues like active infections, severe heart problems, or mental health conditions that would interfere with the study.
  • Have received leukemia treatment within 14 days before starting the study drug, except for hydroxyurea in certain cases.
  • Have taken certain medications that affect liver enzymes within 7 days before the study.
  • Have specific types of leukemia like acute promyelocytic leukemia or AML/MPAL with BCR-ABL1 positive.
  • Have active infections requiring treatment, such as hepatitis B or C, HIV, or active COVID-19.
  • Have ongoing graft-versus-host disease or need immunosuppressive drugs.
  • Have had stem cell therapy within 6 months before the study.
  • Have allergies to the study drugs.
  • Have active, uncontrolled leukemia in the central nervous system.
  • Are not using effective birth control if of childbearing potential.
  • Have had other cancers within 2 years, except for certain skin cancers or in situ cancers.
  • Have not recovered from previous treatments, except for hair loss.
  • Cannot swallow pills or have digestive issues affecting drug absorption.
  • Have significant heart rhythm problems on an ECG.
  • Any other condition that makes participation unsuitable according to the investigator.

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