What side effects are associated with this type of intervention?

Common treatments for Acute Myeloid Leukemia (AML), particularly bispecific antibodies like Flotetuzumab, often result in side effects such as cytokine release syndrome (CRS), which can cause fever, fatigue, headache, and hypotension. Other side effects include neutropenia, increasing infection risk, anemia leading to fatigue and weakness, gastrointestinal symptoms like nausea and diarrhea, and liver enzyme abnormalities.

What prior FDA approvals exist?

The FDA has approved several treatments for Acute Myeloid Leukemia (AML). Notably, venetoclax and ivosidenib have shown proven benefits when combined with hypomethylating agents (HMAs) like azacitidine or decitabine. Venetoclax targets BCL-2, while ivosidenib targets mutant IDH1. Additionally, gilteritinib, an FLT3 inhibitor, has been approved for relapsed or refractory AML. These treatments, while not bispecific antibodies like flotetuzumab, represent significant advancements in targeted therapy for AML.

What other types of research exist?

Gemtuzumab ozogamicin (GO) is a promising alternative for AML patients. It is a humanized anti-CD33 antibody linked to calicheamicin, recently approved in Japan, and has shown efficacy in relapsed or refractory AML patients. Additionally, ongoing research into other novel agents such as Fedratinib and Imetelstat for myelofibrosis, which may have implications for AML treatment, could provide further options.

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Monoclonal Antibodies

Flotetuzumab for Acute Myeloid Leukemia

Phase 1

Waitlist Available

Led By Jonathan Webster, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing flotetuzumab, a drug that targets leukemia cells, in patients with AML whose cancer has returned after a bone marrow transplant. The drug aims to kill the cancerous cells marked by CD123, potentially preventing the cancer from coming back. Flotetuzumab shows promise in treating refractory AML.

Who is the study for?

Adults over 18 with AML that's come back after a transplant can join this trial. They need to have had the transplant at least 30 days ago, not be on certain GVHD treatments, and show signs of AML in their bone marrow but not in the CNS or testes. Their organ functions must meet specific criteria, they shouldn't have uncontrolled infections like HIV or hepatitis, and they agree to use birth control during the study.

What is being tested?

The trial is testing Flotetuzumab for safety and tolerability in patients whose AML has returned post-transplant. It checks if this drug can help when given under these conditions.

What are the potential side effects?

Possible side effects aren't listed here, but since Flotetuzumab is an immunotherapy drug similar to others used for leukemia treatment, it may cause immune-related reactions, infusion responses, fatigue, blood count changes and increase infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

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

Maximum tolerated dose (MTD) of flotetuzumab in patients with relapsed/refractory AML following alloHSCT

Secondary study objectives

Acute graft-versus-host disease (GVHD) incidence

Chronic GVHD incidence

Leukemia, Myelocytic, Acute

+3 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: Flotetuzumab Following Allogeneic TransplantExperimental Treatment1 Intervention

All participants will receive one cycle (28 days) of flotetuzumab. After one cycle, all participants will undergo a bone marrow biopsy to assess response and based on the response, may receive additional cycles up to a total cycle of six cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Flotetuzumab

2022

Completed Phase 1

~10

Do I qualify?Apply below to find out

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

Common treatments for Acute Myeloid Leukemia (AML) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy agents like cytarabine and daunorubicin disrupt DNA replication and cell division, leading to cancer cell death. Targeted therapies, such as FLT3 inhibitors, focus on specific genetic mutations in AML cells, inhibiting their growth. Immunotherapies, including bispecific antibodies like flotetuzumab, harness the immune system to attack AML cells by targeting antigens such as CD123 and CD3. These mechanisms are vital for AML patients as they allow for personalized treatment strategies that can improve efficacy and reduce adverse effects.

Clinical considerations for the use of FLT3 inhibitors in acute myeloid leukemia.