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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 42 months

Awards & highlights

ELEVATE Trial 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.Check my eligibility

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.See study design

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.

ELEVATE Trial 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.

ELEVATE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

ELEVATE 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

Venetoclax

2019

Completed Phase 3

~1990

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCIndustry Sponsor

975 Previous Clinical Trials

6,384,247 Total Patients Enrolled

OncoVerity, Inc.Lead Sponsor

4 Previous Clinical Trials

246 Total Patients Enrolled

argenxIndustry Sponsor

60 Previous Clinical Trials

9,209 Total Patients Enrolled

Media Library

Azacitidine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04150887 — Phase 1

Acute Myeloid Leukemia Research Study Groups: Experimental: Cohort 2: Cusatuzumab + Venetoclax, Cohort 3: Cusatuzumab + Venetoclax + Azacitidine (CVA)

Acute Myeloid Leukemia Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT04150887 — Phase 1

Azacitidine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04150887 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At what locations can this research be accessed?

"The current trial is available in 15 different cities, including Milwaukee, Rochester and Montreal. To reduce the burden on participants enrolled in this study, it's recommended to choose a site within your vicinity."

Answered by AI

Are there still openings for those wishing to participate in this investigation?

"According to clinicaltrials.gov, this particular trial has ceased its active recruitment of participants; the study was initially published on December 23rd 2019 and last edited November 3rd 2022. Despite no longer seeking patients, there are 1,805 other medical experiments that continue to look for volunteers."

Answered by AI

Has the regulatory agency endorsed Cusatuzumab for public use?

"Taking all existing evidence into account, the safety of Cusatuzumab is estimated to be a 1 due to its Phase 1 status. This means that there are only limited data points available in support of both efficacy and safety."

Answered by AI

Are there any past studies available for review regarding Cusatuzumab?

"Cusatuzumab first surfaced in 2006 at the Chinese University of Hong Kong-Prince of Wales Hospital. Since then, 210 trials have been finished and an additional 340 are now recruiting participants primarily from Milwaukee, Wisconsin."

Answered by AI

What medical ailments is Cusatuzumab prescribed for?

"Cusatuzumab is usually used to treat induction chemotherapy, but has also been prescribed for multiple conditions including refractory anemias, leukemia, myelocytic and acute multilineage dysplasia."

Answered by AI

How many participants have been recruited for this trial thus far?

"Currently, this medical trial is not recruiting participants. Initially posted on December 23rd 2019 and last modified November 3nd 2022, it does not appear to be taking new patients at the moment. If you are searching for other clinical trials related to leukemia, myeloid acute or Cusatuzumab there are 1465 and 340 respectively actively enrolling individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cusatuzumab in Combination With Background Therapy for the Treatment of Participants With Acute Myeloid Leukemia

2019. "Cusatuzumab in Combination With Background Therapy for the Treatment of Participants With Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04150887.

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