What side effects are associated with this type of intervention?

Common treatments for Acute Myeloid Leukemia (AML), such as cytarabine, daunorubicin, idarubicin, and venetoclax, are associated with several side effects. These include severe cytopenias (low blood cell counts), which can lead to increased risk of infections, bleeding, and anemia. Gastrointestinal symptoms like nausea, vomiting, and diarrhea are also common. Additionally, patients may experience fatigue, mucositis (inflammation of the mucous membranes), and liver function abnormalities. More severe side effects can include cardiotoxicity (heart damage) with anthracyclines like daunorubicin and idarubicin, and tumor lysis syndrome with venetoclax, which requires careful monitoring and management.

What prior FDA approvals exist?

The FDA has approved several treatments for Acute Myeloid Leukemia (AML), including hypomethylating agents like azacitidine and decitabine, which have shown superior survival rates compared to supportive care. Targeted therapies such as venetoclax, often combined with azacitidine or decitabine, have also been approved for newly diagnosed AML patients who are ineligible for intensive chemotherapy. Additionally, gemtuzumab ozogamicin, an antibody-drug conjugate targeting CD33, has been approved for certain AML patients. These treatments represent a shift towards more targeted and less intensive therapeutic options for AML.

What other types of research exist?

Promising novel alternatives to ABBV-787 for AML patients include: <ol> <li>MCL-1-selective inhibitor A-1210477, which can counteract resistance to BCL-2 antagonist ABT-199 in MCL-1-dependent AML cells.</li> <li></li> </ol> Pan-PIM kinase inhibitors, which have shown single-agent antiproliferative activity and synergy with cytarabine in AML models. 3. Combination therapies involving AMN107 (a potent tyrosine kinase inhibitor) and histone deacetylase inhibitors like LBH589, which have demonstrated efficacy against Bcr-Abl-expressing leukemia cells.

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ABBV-787 for Acute Myeloid Leukemia

Q: What is the mechanism of action of this treatment?

The most common treatments for Acute Myeloid Leukemia (AML) include chemotherapy, targeted therapy, and investigational drugs. Chemotherapy agents, such as cytarabine and anthracyclines, disrupt DNA replication and cell division, causing the death of leukemia cells. Targeted therapies focus on specific genetic mutations or proteins that promote leukemia cell growth, such as FLT3, IDH, and BCL-2 inhibitors. Investigational drugs like ABBV-787 aim to target novel pathways or molecules involved in AML. Understanding these mechanisms is essential for tailoring treatment to the patient's specific leukemia profile, potentially improving outcomes and minimizing side effects.

Phase 1

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

QT interval corrected for heart rate (QTc) <= 470 msec using Fridericia's correction, and no other clinically significant cardiac abnormalities.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, ABBV-787, for adults with acute myeloid leukemia that hasn't responded to other treatments. The drug is given through an IV, and the study aims to find the safest dose while monitoring its effects and side effects.

Who is the study for?

This trial is for adults with Acute Myeloid Leukemia (AML) who have tried up to three treatments without success. They should be in good physical condition (ECOG score of 0 or 1), have acceptable heart health, and a white blood cell count below a certain level. People can't join if they've had more than three prior AML treatments or don't meet specific health criteria.

What is being tested?

The study tests the safety and behavior of ABBV-787, an experimental drug for AML, when given through IV. Participants will receive increasing doses to find the highest dose they can tolerate without severe side effects over approximately three years.

What are the potential side effects?

Potential side effects include reactions related to infusion, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, nausea, and other symptoms that may arise from higher doses as the maximum tolerated dose is determined.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or can carry out light work.

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My heart's electrical activity is normal, with no significant issues.

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I have been diagnosed with a specific type of leukemia that is not promyelocytic.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 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

Maximum Tolerated Dose (MTD) Based on Dose-Limiting Toxicities (DLT)

Number of Participants with Adverse Events (AE)

Secondary study objectives

Antidrug Antibody (ADA)

Area Under the Plasma Concentration-time Curve (AUC) of ABBV-787

Duration of Response (DOR)

+15 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: ABBV-787Experimental Treatment1 Intervention

Participants will receive increasing doses of ABBV-787 until the maximum tolerated dose (MTD) during the 3 year treatment period.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Acute Myeloid Leukemia (AML) include chemotherapy, targeted therapy, and investigational drugs. Chemotherapy agents, such as cytarabine and anthracyclines, disrupt DNA replication and cell division, causing the death of leukemia cells. Targeted therapies focus on specific genetic mutations or proteins that promote leukemia cell growth, such as FLT3, IDH, and BCL-2 inhibitors. Investigational drugs like ABBV-787 aim to target novel pathways or molecules involved in AML. Understanding these mechanisms is essential for tailoring treatment to the patient's specific leukemia profile, potentially improving outcomes and minimizing side effects.

Role of epigenetic in leukemia: From mechanism to therapy.Emerging Epigenetic Therapeutic Targets in Acute Myeloid Leukemia.Molecular targeting in acute myeloid leukemia.