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Monoclonal Antibodies

Venetoclax + Lintuzumab for Acute Myeloid Leukemia

Phase 1 & 2

Recruiting

Research Sponsored by Actinium Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

ECOG ≤ 2

Refractory or relapsed AML which will include:

Must not have

Have received prior radiation to maximally tolerated levels to any critical normal organ

Known HIV infection or known hepatitis B or hepatitis C infection (with a detectable viral load)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer drug to see what the maximum tolerated dose is and how well it works in people with relapsed or refractory AML.

Who is the study for?

This trial is for adults with Acute Myeloid Leukemia (AML) that has come back or hasn't responded to treatment. They should have a certain level of kidney and liver function, controlled blast counts in the blood, and be able to perform daily activities with some limitations (ECOG ≤ 2). People can't join if they have active leukemia in the brain, HIV/Hepatitis B/C infections, recent strong drug interactions, previous high-dose radiation to vital organs, severe heart issues or other cancers within 2 years.

What is being tested?

The study tests how safe and effective it is to add Lintuzumab-Ac225 to Venetoclax for AML patients who've relapsed or haven't responded well. Phase I finds the highest dose patients can take without too many side effects. Phase II checks how many achieve complete remission up to six months later without other AML treatments.

What are the potential side effects?

Possible side effects include reactions at injection sites, lowered blood cell counts leading to increased infection risk or bleeding problems, fatigue, liver issues indicated by altered lab results, nausea or vomiting due to digestive system impact. Each patient's experience may vary.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and do some daily activities.

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My AML has not responded to treatment or has come back.

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My condition did not improve after at least one treatment.

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My kidneys are working well.

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My leukemia has returned, with more than 5% of cells in my bone marrow being cancerous.

Exclusion Criteria

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

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I have received the maximum safe radiation dose to a vital organ.

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I have HIV or hepatitis B/C with a detectable viral load.

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My AML did not respond to treatment for the current relapse.

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I have a serious infection that is not under control.

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I have leukemia that has spread to my brain.

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I have a serious heart condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 2 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

Phase I: Maximum Tolerated Dose (MTD) of Lintuzumab-Ac225

Phase II: Overall Response (CR + CRh + CRi)

Secondary study objectives

Phase I and II: DFS

Phase I and II: Evaluate BH3 priming assay results

Phase I and II: Evaluate incidence of AEs and SAEs

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Phase I and Phase IIExperimental Treatment3 Interventions

Lintuzumab-Ac225 administered on Day 5 of each cycle for four cycles (unless in the 0.5 μCi/kg or 0.25 μCi/kg cohorts, where there is a potential for an additional four cycles, pending PI and Medical Monitor review). Venetoclax taken on Days 1-21 of each cycle for up to 12 cycles. Each cycle is 28 days, with a potential to expand to 42 days to allow for full hematologic recovery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lintuzumab-Ac225

2012

Completed Phase 2

~40

Venetoclax

2019

Completed Phase 3

~2200