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Monoclonal Antibodies

Venetoclax, Azacitidine, and Cusatuzumab for Acute Myeloid Leukemia

Phase 2

Recruiting

Research Sponsored by OncoVerity, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of AML according to ICC 2022 (excluding MDS/AML with 10-19% blasts)

Be older than 18 years old

Must not have

Received a hypomethylating agent (HMA) or venetoclax for MDS or myeloproliferative neoplasm

Leukemic involvement in the central nervous system

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of randomization until the date of death from any cause, assessed up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if adding the new drug cusatuzumab to the standard treatment of venetoclax and azacitidine is more effective in treating acute myeloid leukemia (

Who is the study for?

This trial is for adults with newly diagnosed AML who can't have intensive therapy. They must understand the study and agree to participate, not have had certain treatments before joining, be at least 75 years old or have a performance status of 2 or 3 if younger, and meet specific health criteria related to heart, lung function, kidney clearance, and liver function.

What is being tested?

The trial tests if adding cusatuzumab to venetoclax and azacitidine improves survival in AML patients ineligible for chemotherapy. It compares this combination against the standard treatment of venetoclax and azacitidine alone.

What are the potential side effects?

Potential side effects include reactions where the drugs are injected, fatigue, nausea, diarrhea or constipation. There may also be blood-related issues like low counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with AML, not related to MDS with 10-19% blasts.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with specific drugs for my blood disorder.

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My leukemia has spread to my brain or spinal cord.

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I have been diagnosed with acute promyelocytic leukemia.

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I do not have any active cancer other than the one specified.

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I do not have any ongoing infections.

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I have had a stem cell transplant in the past.

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I have trouble swallowing pills or have serious stomach issues.

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My daily activity is not severely limited by my health.

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I have recently used drugs that suppress the immune system.

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I have not received a live vaccine in the last 4 weeks.

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I have an active hepatitis B or C infection or another liver disease.

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I have a specific heart condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization until the date of death from any cause, assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of randomization until the date of death from any cause, assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until the date of death from any cause, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall survival

Secondary study objectives

Complete Remission rate

Complete Remission rate (CR)

Composite CR rate (CRc)

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cusatuzumab in combination with venetoclax and azacitidineExperimental Treatment3 Interventions

Cusatuzumab 20 mg/kg administered intravenously on days 3 and 17 in combination with venetoclax administered orally up to 400 mg once daily and azacitidine 75 mg/m\^2 administered subcutaneously or intravenously once daily for 7 days of a 28 day cycle

Group II: Venetoclax in combination with azacitidineActive Control2 Interventions

Venetoclax administered orally up to 400 mg once daily and azacitidine 75 mg/m\^2 administered subcutaneously or intravenously once daily for 7 days of a 28 day cycle

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Azacitidine

2012

Completed Phase 3

~1440

Cusatuzumab

2020

Completed Phase 1

~10