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Chemotherapy

FLAG-Ida + Pivekimab for Acute Myeloid Leukemia

Phase 1

Recruiting

Led By Mary-Elizabeth Percival

Research Sponsored by Fred Hutchinson Cancer Center

Eligibility Criteria Checklist

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

Must have

Age >= 18 years

Diagnosis of untreated AML other than acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) or variants according to the 5th edition of the World Health Organization (WHO) classification of hematolymphoid tumors. Patients with myelodysplastic, myeloproliferative, or myelodysplastic/myeloproliferative neoplasms and ≥10% blasts in blood and/or bone marrow, are also eligible, as are patients with mixed phenotype acute leukemia (MPAL). Outside diagnostic material is acceptable to establish diagnosis; submission of peripheral blood specimen for flow cytometry performed at the study institution should be considered. Diagnostic material must have been submitted for cytogenetic and/or molecular testing as clinically appropriate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial tests a combination of chemo drugs & antibody-linked drug to treat AML & other high-grade myeloid neoplasms. G-CSF helps bone marrow make more white blood cells. This may kill more cancer cells than chemo alone.

Who is the study for?

Adults diagnosed with high-risk acute myeloid leukemia (AML) or related conditions, who haven't been treated yet. They must have normal heart function and kidney clearance, no severe infections, and agree to use contraception. Excluded are those with certain other leukemias, FLT3-mutated AML, life-threatening illnesses, known drug allergies, or pregnant/breastfeeding women.Check my eligibility

What is being tested?

The trial is testing the best dose of Pivekimab Sunirine combined with a chemotherapy regimen called FLAG-Ida for treating newly diagnosed adverse risk AML. It aims to see if this combination therapy is more effective than chemotherapy alone in killing cancer cells.See study design

What are the potential side effects?

Potential side effects include reactions to the monoclonal antibody Pivekimab Sunirine such as infusion-related reactions and allergic responses. Chemotherapy can cause fatigue, nausea, low blood cell counts increasing infection risk, hair loss and damage to organs like the heart.

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 a specific type of untreated AML, not including APL.

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My leukemia is considered high-risk based on specific tests.

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My heart pumps well and I don't have heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Incidence of dose-limiting toxicities during cycle 1

Secondary outcome measures

Complete remission rates

Duration of cytopenias

Incidence of adverse events

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (PVEK, FLAG-Ida)Experimental Treatment10 Interventions

See Detailed Description.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 3

~1100

Biospecimen Collection

2004

Completed Phase 2

~1700

Bone Marrow Aspiration

2011

Completed Phase 2

~1740

Echocardiography

2013

Completed Phase 4

~11670

Bone Marrow Biopsy

2021

Completed Phase 2

~10

Granulocyte Colony-Stimulating Factor

2016

Completed Phase 2

~50

Idarubicin

2014

Completed Phase 4

~4330

Cytarabine

2016

Completed Phase 3

~3310

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

ImmunoGen, Inc.Industry Sponsor

32 Previous Clinical Trials

3,801 Total Patients Enrolled

Fred Hutchinson Cancer CenterLead Sponsor

557 Previous Clinical Trials

1,343,485 Total Patients Enrolled

Mary-Elizabeth PercivalPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

3 Previous Clinical Trials

100 Total Patients Enrolled

Frequently Asked Questions

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

Has the FDA certified PVEK and FLAG-Ida as viable treatments?

"Considering the confined amount of safety and efficacy data, Treatment (PVEK, FLAG-Ida) was assigned a score of 1 on our risk scale. This is due to it currently being in Phase One clinical trials."

Answered by AI

Is this experiment currently enlisting participants?

"Clinicaltrials.gov records have established that this medical trial, which was initially posted on November 1st 2023 and most recently updated September 5th 2023, has concluded its patient recruitment period. Fortunately, there are still 4008 other clinical trials open to participants at the current moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combination Chemotherapy (FLAG-Ida) With Pivekimab Sunirine (PVEK [IMGN632]) for the Treatment of Newly Diagnosed Adverse Risk Acute Myeloid Leukemia and Other High-Grade Myeloid Neoplasms

2023. "Combination Chemotherapy (FLAG-Ida) With Pivekimab Sunirine (PVEK [IMGN632]) for the Treatment of Newly Diagnosed Adverse Risk Acute Myeloid Leukemia and Other High-Grade Myeloid Neoplasms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06034470.

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