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Bispecific Antibody

Flotetuzumab for Acute Myeloid Leukemia

Phase 2

Recruiting

Led By Matthew Christopher, M.D., Ph.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

At least 18 years of age.

Patients must be status post allo-HCT (including: matched related, matched unrelated, haploidentical, mismatched unrelated; and cord blood HCT).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through follow-up (approximately 2 years)

Awards & highlights

Study Summary

This trial is testing a new drug for leukemia that may be safer and more effective than current treatments, and scientists think it may help the body's immune system better target cancer cells.

Who is the study for?

This trial is for adults with relapsed AML or MDS after an Allo-HCT. Participants must have stable thyroid function, recovered from previous chemo effects, adequate organ function, and an ECOG performance status ≤ 2. They should not be on certain immunosuppressants and must agree to effective contraception methods.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of Flotetuzumab alone or combined with donor lymphocyte infusion (DLI) in treating relapsed AML/MDS post-Allo-HCT. The goal is to see if these treatments can improve patient outcomes by targeting leukemic cells more effectively.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune system activation against cancer cells which could affect normal cells too, leading to symptoms like fever, fatigue, or weakness. Specific side effects will depend on individual responses to Flotetuzumab and DLI.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have had a stem cell transplant from a donor.

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I can take care of myself but might not be able to do heavy physical work.

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I can reduce my corticosteroid dose to 0.5mg/kg or less per day.

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My condition is a relapse of AML or MDS, not including acute promyelocytic leukemia.

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My white blood cell count is 20,000/mm3 or less, and I may be using medication to control it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through follow-up (approximately 2 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through follow-up (approximately 2 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through follow-up (approximately 2 years) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Chromium

Secondary outcome measures

Cytokine release syndrome (CRS) grading as measured by ASTCT Consensus Guidelines

Efficacy as measured by number of participants with CR and CRi

Incidence of acute Graft versus Host Disease (GvHD) as measured by MAGIC Criteria

+9 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: FlotetuzumabExperimental Treatment2 Interventions

Will start on cycle 1 day 1 on the dose escalation ramp schedule of flotetuzumab as a continuous intravenous (IV) infusion. Patients will be initiated at 30 ng/kg/day and have their dose increased daily to a target goal of 500 ng/kg/day by day 7 Patients will continue on flotetuzumab at 500 ng/kg/day for the remaining 21 days of the 28 day cycle. On cycle 1 day 28, patients will undergo bone marrow biopsy for assessment of disease status. Patients who have achieved a CR/CRi will proceed to a second cycle per protocol, while patients with a PR or SD or better may proceed to cycle 2 with permission of the investigator. Patients with available donor lymphocytes may receive DLI concurrently with flotetuzumab during Cycle 1 and/or Cycle 2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Donor lymphocyte infusion

2013

Completed Phase 2

~60

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,664 Previous Clinical Trials

40,926,108 Total Patients Enrolled

Washington University School of MedicineLead Sponsor

1,935 Previous Clinical Trials

2,299,785 Total Patients Enrolled

MacroGenicsIndustry Sponsor

48 Previous Clinical Trials

5,351 Total Patients Enrolled

Media Library

Flotetuzumab (Bispecific Antibody) Clinical Trial Eligibility Overview. Trial Name: NCT04582864 — Phase 2

Acute Myelogenous Leukemia Research Study Groups: Flotetuzumab

Acute Myelogenous Leukemia Clinical Trial 2023: Flotetuzumab Highlights & Side Effects. Trial Name: NCT04582864 — Phase 2

Flotetuzumab (Bispecific Antibody) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04582864 — Phase 2

Frequently Asked Questions

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

How many individuals have been enrolled in this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this medical investigation is presently recruiting participants and was first posted on the 20th of May 2021 before being updated lastly on September 7th 2022. A total of 25 patients are required from a single research centre."

Answered by AI

What other investigations have been conducted on the subject of MGD006?

"Currently, MGD006 is the subject of 3 ongoing clinical trials with none in Phase 3. These studies are scattered across 21 different locations, though some have a concentration around Cincinnati, Ohio."

Answered by AI

Has the FDA officially sanctioned MGD006 for use?

"Although MGD006 has not yet been proven to be effective, there is some evidence indicating it's safety. Consequently, the team at Power gave this drug a rating of 2 on their risk scale."

Answered by AI

Are researchers currently recruiting for this study?

"Affirmative. According to the information hosted on clinicaltrials.gov, this experiment is currently recruiting participants since its initial posting of May 20th 2021 and most recently updated on September 7th 2022. 25 volunteers are required for a single site location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Flotetuzumab for Relapsed Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Following Allogeneic Hematopoietic Cell Transplantation (Allo-HCT)

2021. "Flotetuzumab for Relapsed Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Following Allogeneic Hematopoietic Cell Transplantation (Allo-HCT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04582864.