What side effects are associated with this type of intervention?

Common treatments for Acute Myelogenous Leukemia (AML), particularly cytotoxic and targeted therapies, often have a range of side effects. Cytotoxic therapies, such as those involving chemotherapeutic agents, can lead to neutropenia, thrombocytopenia, anemia, nausea, vomiting, and mucositis. Targeted therapies, like BCR-ABL tyrosine kinase inhibitors (e.g., imatinib, dasatinib), can cause edema, thrombocytopenia, neutropenia, and gastrointestinal issues. Additionally, newer agents like ivosidenib, used for IDH1-mutated AML, have been associated with QT interval prolongation, IDH differentiation syndrome, and leukocytosis. These side effects highlight the need for careful monitoring and supportive care during treatment.

What prior FDA approvals exist?

Several drugs have been approved by the FDA for the treatment of Acute Myelogenous Leukemia (AML), particularly focusing on cytotoxic and targeted therapies. Cytotoxic agents like cytarabine and anthracyclines (e.g., daunorubicin) have been mainstays in AML treatment. Targeted therapies have also gained traction, including midostaurin for FLT3-mutated AML, enasidenib for IDH2-mutated AML, and ivosidenib for IDH1-mutated AML. Venetoclax, a BCL-2 inhibitor, has been approved in combination with hypomethylating agents like azacitidine or decitabine for newly diagnosed AML in patients who are ineligible for intensive chemotherapy. These treatments reflect the evolving landscape of AML therapy, incorporating both traditional cytotoxic agents and newer targeted approaches.

What other types of research exist?

Promising alternatives to AB8939 for AML treatment include: 1) Glasdegib combined with low-dose cytarabine (LDAC), which has shown long-term efficacy and safety in patients ineligible for intensive chemotherapy. 2) SCH66336 combined with imatinib, which has demonstrated enhanced antiproliferative activity and induced apoptosis in imatinib-resistant BCR-ABL cells. These therapies offer potential benefits and should be discussed with a healthcare provider.

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Protein Degrader

AB8939 for Acute Myeloid Leukemia

Phase 1 & 2

Recruiting

Led By Norbert Vey, MD

Research Sponsored by AB Science

Eligibility Criteria Checklist

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

Must have

Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification and eligible to second or third line of treatment

ECOG performance status ≤ 1

Must not have

Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion

Women with a positive pregnancy test

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 56 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests AB8939, a new drug, for safety and effectiveness in patients with certain blood cancers that haven't responded to other treatments. The study will determine the best dose and schedule for future trials.

Who is the study for?

This trial is for adults with Acute Myeloid Leukemia or high-risk Myelodysplastic Syndromes who've had previous treatments fail. They must be in good physical condition (ECOG ≤ 1), able to consent, and follow study procedures like bone marrow biopsies. It's not for those eligible for standard care, stem cell transplant, have certain leukemia types or CNS involvement, recent transplants, or are pregnant/breastfeeding.

What is being tested?

The trial tests AB8939's safety and tolerability in patients with AML by finding the highest dose they can take without serious side effects. Participants will also receive Azacitidine as part of the treatment regimen.

What are the potential side effects?

Specific side effects aren't listed but generally include reactions related to drug tolerance levels such as fatigue, nausea, blood count changes, and potential organ-specific toxicity which will be monitored closely.

Eligibility Criteria

Inclusion Criteria

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

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I have acute myeloid leukemia and need second or third line treatment.

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I am fully active and can carry on all my pre-disease activities without restriction.

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I have a high-risk myelodysplastic syndrome not responding to first treatments.

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.

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I am currently pregnant.

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I have active leukemia in my brain or spinal cord.

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I have been diagnosed with a specific type of leukemia called acute promyelocytic leukemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 56 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 56 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 56 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Rate of dose limiting toxicity (DLT)

Secondary study objectives

Objective Response Rate

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: AB8939 plus azacitidineExperimental Treatment2 Interventions

AB8939 administered in combination with azacitidine

Group II: AB8939Experimental Treatment1 Intervention

AB8939 administered as a single agent

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Azacitidine

2012

Completed Phase 3

~1440

0 / 7Eligibility 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 Myelogenous Leukemia (AML) include cytotoxic therapies like cytarabine and daunorubicin, which disrupt DNA synthesis and function, leading to cell death. These treatments target rapidly dividing cells, including cancerous ones. Targeted therapies, such as FLT3 and IDH inhibitors, focus on specific genetic mutations or abnormal proteins that drive AML cell growth. These therapies aim to minimize damage to normal cells while effectively targeting cancer cells. Understanding these mechanisms helps in selecting the most appropriate treatment, potentially improving outcomes and reducing side effects for AML patients.