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Anti-metabolites

Cusatuzumab + Background Therapy for Acute Myeloid Leukemia (ELEVATE Trial)

Phase 1

Waitlist Available

Research Sponsored by OncoVerity, Inc.

Eligibility Criteria Checklist

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

Must have

Must be ineligible for intensive chemotherapy

De novo or secondary AML

Must not have

Eligible for an allogeneic hematopoietic stem cell transplantation at study entry

A history of human immunodeficiency virus (HIV) antibody positive or tests positive for HIV if tested at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 42 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will help researchers learn more about how safe and tolerable cusatuzumab is when used with different AML treatments.

Who is the study for?

This trial is for adults with a new or secondary type of acute myeloid leukemia (AML) who haven't been treated yet, except to manage high white blood cell counts. They should be fairly active and not eligible for intensive chemo or stem cell transplant at the start. People with HIV, central nervous system leukemia, allergies to the drugs being tested, or recent live vaccines can't join.

What is being tested?

The study tests cusatuzumab combined with other AML treatments like venetoclax and azacitidine. It aims to understand how safe this combination is and how well patients tolerate it.

What are the potential side effects?

Possible side effects include reactions related to the immune system due to cusatuzumab, low blood counts from venetoclax which could increase infection risk, and gastrointestinal issues from azacitidine.

Eligibility Criteria

Inclusion Criteria

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

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I cannot undergo intensive chemotherapy.

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My condition is acute myeloid leukemia (AML), either newly diagnosed or after a previous cancer.

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I have been diagnosed with acute myeloid leukemia, not including acute promyelocytic leukemia.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

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

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I am eligible for a stem cell transplant from a donor.

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I am HIV positive.

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My leukemia has spread to my brain or spinal cord.

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I am not allergic to cusatuzumab, venetoclax, azacitidine, or their ingredients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 42 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 42 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 42 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Frequency and Severity of Adverse Events (AEs), Laboratory Abnormalities, and Physical Exam Findings as a Measure of Safety

Secondary study objectives

Cohort 2 and 3: Duration of Response

Cohort 2 and 3: Red Blood Cell (RBC) or Platelet Transfusion Independence

Cohort 2 and 3: Time to Response

+9 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

Group I: Experimental: Cohort 2: Cusatuzumab + VenetoclaxExperimental Treatment2 Interventions

Participants enrolled in this cohort will receive venetoclax ramp-up to 400 mg orally (as background therapy) starting on Cycle 1 Day 1 and followed by 400 mg daily dosing starting on Cycle 1 Day 4 plus cusatuzumab IV on Day 3 and Day 17 of each 28-day cycle. Cohort 2 will not be enrolled in the US.

Group II: Cohort 3: Cusatuzumab + Venetoclax + Azacitidine (CVA)Experimental Treatment3 Interventions

Participants enrolled at US sites will receive cusatuzumab 10 mg/kg and potentially escalate to 20 mg/kg IV in combination with azacitidine 75 mg/m\^2 SC or IV plus venetoclax ramp-up to 400 mg orally (as background therapies). Participants enrolled from ex-US sites will receive cusatuzumab 20 mg/kg and potentially de-escalate to 10 mg/kg IV in combination with azacitidine 75 mg/m\^2 SC or IV plus venetoclax ramp-up to 400 mg orally (as background therapies).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cusatuzumab

2020

Completed Phase 1

~10

Azacitidine

2012

Completed Phase 3

~1440