Study Comparing Venetoclax and Azacitidine with and without Cusatuzumab for Newly Diagnosed AML Patients Not Eligible for Intensive Therapy

Sponsor: OncoVerity, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06384261

Provider View

This clinical trial is exploring whether adding the experimental drug cusatuzumab to the standard treatment of venetoclax and azacitidine can improve outcomes for patients with acute myeloid leukemia (AML) who cannot undergo intensive chemotherapy.

Patient Parameters

Program Overview

The aim of this study is to determine if adding cusatuzumab to the usual treatment of venetoclax and azacitidine can help patients with acute myeloid leukemia (AML) live longer. This study is for patients who have been newly diagnosed with AML and are not able to receive intensive chemotherapy. The trial will compare the effectiveness of the treatment with and without cusatuzumab.

Description

This study is a Phase 2 trial that will take place in multiple centers. It will compare the effectiveness and safety of adding cusatuzumab to the standard treatment of venetoclax and azacitidine for people with newly diagnosed acute myeloid leukemia (AML) who cannot have intensive chemotherapy.

Participants will be randomly assigned to receive either the experimental treatment (cusatuzumab with venetoclax and azacitidine) or the standard treatment (venetoclax and azacitidine alone). Before joining the study, participants will have a bone marrow biopsy to confirm their AML diagnosis and assess their risk level.

The study will include participants with different risk levels, focusing more on those with higher risk. Participants will be divided into groups based on their risk: 72 with high risk, 24 with intermediate risk, and 24 with low risk. They will then be randomly assigned to one of the two treatment groups in a 2:1 ratio.

Eligibility Criteria

Inclusion Criteria

  • Men and women aged 18 years or older.
  • Must understand and agree to participate in the study by signing a consent form.
  • Diagnosed with acute myeloid leukemia (AML), except for certain subtypes.
  • Have not received prior treatment for AML, except for emergency measures to control high white blood cell counts.
  • Considered unfit for intensive chemotherapy due to age (75 or older) or specific health conditions.
  • Must have adequate liver and kidney function based on specific medical tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for three months after.
  • Men must agree to use birth control and not donate sperm during the study and for three months after.
  • Participants with HIV can join if they meet certain health criteria.

Exclusion Criteria

  • Any previous treatment for AML, except for emergency measures.
  • Previous use of certain drugs for other blood disorders.
  • Cancer spread to the central nervous system.
  • Specific types of leukemia, like acute promyelocytic leukemia.
  • Poor overall health status based on specific criteria.
  • Recent use of immune-suppressing drugs or live vaccines.
  • Other active cancers requiring treatment in the last two years, with some exceptions.
  • Active infections or history of certain transplants.
  • Active hepatitis B or C infections.
  • Severe heart conditions or allergies to study drugs.
  • Difficulty swallowing pills or conditions affecting digestion.
  • Any condition that the study doctor believes would not be in the participant's best interest.
  • Recent major surgery.

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