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New hope for young AML patients: targeted drug combo tested in phase 2 trial

NCT ID NCT06917911

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 35 times

Summary

This study tests two different drug combinations for younger adults with a specific type of acute myeloid leukemia (CBF-AML). One group gets standard chemotherapy plus a targeted antibody, while the other gets the same chemotherapy plus a newer targeted pill. The goal is to see which combination works better at clearing the cancer with fewer side effects. About 162 people will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 162 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2027

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 59 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * GENERAL MYELOMATCH CRITERIA: Patients must be registered to the Master Screening and Reassessment Protocol, MYELOMATCH, and assigned to this protocol by the MATCHBox Treatment Verification Team * GENERAL MYELOMATCH CRITERIA: Participants must not have received prior anti-cancer therapy for AML or myelodysplastic syndrome (MDS) * Note: Hydroxyurea to control the white blood cell count (WBC) and cytarabine up to 1g for urgent cytoreduction is allowed. * Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility * GENERAL MYELOMATCH CRITERIA: Participants must not receive any cytarabine-containing therapy other than up to 1g of cytarabine, which is allowed for urgent cytoreduction. Hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide is allowed * Diagnosis of AML with t(8;21)(q22;q22.1)/RUNX1::RUNX1T1 or AML with inv(16)(p13.1q22) or t(16;16)(p13.1;q22)/CBFB::MYH11. No FLT3 mutation (these patients should be considered for a FLT3-focused MYELOMATCH study) * Secondary CBF-AML (e.g., prior pre-leukemic hematologic malignancy or history of chemotherapy/radiation therapy) is allowed. * No prior AML or MDS-directed therapy except for urgent treatment of leukocytosis with leukapheresis, cytarabine, and hydroxyurea, Prior intrathecal chemotherapy for central nervous system (CNS) involvement of AML is permitted * Age 18-59 years * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3 * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless patient has a history of Gilbert syndrome and direct bilirubin is ≤ 1.5 x ULN) * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x upper limit of normal (ULN) * Glomerular filtration rate (GFR) ≥ 30 mL/min/1.73m\^2 * Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done ≤ 7 days prior to registration is required * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Participants with CNS disease are eligible for this trial and will be treated according to institutional guidelines with intrathecal chemotherapy for this aspect of their disease * Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better * No known medical condition causing an inability to swallow oral formulations of agents

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Conditions

The condition(s) this trial relates to.

core binding factor acute myeloid leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Core binding factor acute myeloid leukemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    64 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baptist Cancer Center-Grenada

    RECRUITING

    Grenada, Mississippi, 38901, United States

    Contact Email: •••••@•••••

  • Baptist Memorial Hospital and Cancer Center-Collierville

    RECRUITING

    Collierville, Tennessee, 38017, United States

    Contact Email: •••••@•••••

  • Baptist Memorial Hospital and Cancer Center-Desoto

    RECRUITING

    Southhaven, Mississippi, 38671, United States

    Contact Email: •••••@•••••

  • Baptist Memorial Hospital and Cancer Center-Golden Triangle

    RECRUITING

    Columbus, Mississippi, 39705, United States

    Contact Email: •••••@•••••

  • Baptist Memorial Hospital and Cancer Center-Memphis

    RECRUITING

    Memphis, Tennessee, 38120, United States

    Contact Email: •••••@•••••

  • Baptist Memorial Hospital and Cancer Center-Oxford

    RECRUITING

    Oxford, Mississippi, 38655, United States

    Contact Email: •••••@•••••

  • Baptist Memorial Hospital and Cancer Center-Union County

    RECRUITING

    New Albany, Mississippi, 38652, United States

    Contact Email: •••••@•••••

  • Benefis Sletten Cancer Institute

    RECRUITING

    Great Falls, Montana, 59405, United States

    Contact Email: •••••@•••••

  • Billings Clinic Cancer Center

    RECRUITING

    Billings, Montana, 59101, United States

    Contact Email: •••••@•••••

  • Bozeman Health Deaconess Hospital

    RECRUITING

    Bozeman, Montana, 59715, United States

    Contact Email: •••••@•••••

  • Community Medical Center

    RECRUITING

    Missoula, Montana, 59804, United States

    Contact Email: •••••@•••••

  • Drexel Town Square Health Center

    RECRUITING

    Oak Creek, Wisconsin, 53154, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Froedtert Menomonee Falls Hospital

    RECRUITING

    Menomonee Falls, Wisconsin, 53051, United States

  • Froedtert West Bend Hospital/Kraemer Cancer Center

    RECRUITING

    West Bend, Wisconsin, 53095, United States

  • Froedtert and MCW Moorland Reserve Health Center

    RECRUITING

    New Berlin, Wisconsin, 53151, United States

  • Geisinger Medical Center

    RECRUITING

    Danville, Pennsylvania, 17822, United States

    Contact Email: •••••@•••••

  • Geisinger Wyoming Valley/Henry Cancer Center

    RECRUITING

    Wilkes-Barre, Pennsylvania, 18711, United States

    Contact Email: •••••@•••••

  • Gundersen Lutheran Medical Center

    RECRUITING

    La Crosse, Wisconsin, 54601, United States

    Contact Email: •••••@•••••

  • Huntsman Cancer Institute/University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

    Contact Email: •••••@•••••

  • Kootenai Clinic Cancer Services - Post Falls

    RECRUITING

    Post Falls, Idaho, 83854, United States

    Contact Email: •••••@•••••

  • Kootenai Clinic Cancer Services - Sandpoint

    RECRUITING

    Sandpoint, Idaho, 83864, United States

    Contact Email: •••••@•••••

  • Kootenai Health - Coeur d'Alene

    RECRUITING

    Coeur d'Alene, Idaho, 83814, United States

    Contact Email: •••••@•••••

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Hospital West

    RECRUITING

    Pembroke Pines, Florida, 33028, United States

  • Montefiore Medical Center - Moses Campus

    RECRUITING

    The Bronx, New York, 10467, United States

  • Nebraska Medicine-Bellevue

    RECRUITING

    Bellevue, Nebraska, 68123, United States

  • Nebraska Medicine-Village Pointe

    RECRUITING

    Omaha, Nebraska, 68118, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

    Contact Email: •••••@•••••

  • Prisma Health Cancer Institute - Butternut

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • Prisma Health Cancer Institute - Easley

    RECRUITING

    Easley, South Carolina, 29640, United States

  • Prisma Health Cancer Institute - Eastside

    RECRUITING

    Greenville, South Carolina, 29615, United States

  • Prisma Health Cancer Institute - Faris

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • Prisma Health Cancer Institute - Greer

    RECRUITING

    Greer, South Carolina, 29650, United States

  • Prisma Health Cancer Institute - Seneca

    RECRUITING

    Seneca, South Carolina, 29672, United States

  • Prisma Health Cancer Institute - Spartanburg

    RECRUITING

    Boiling Springs, South Carolina, 29316, United States

  • Roswell Park Cancer Institute

    RECRUITING

    Buffalo, New York, 14263, United States

  • Siteman Cancer Center at Christian Hospital

    RECRUITING

    St Louis, Missouri, 63136, United States

    Contact Email: •••••@•••••

  • Siteman Cancer Center at Saint Peters Hospital

    RECRUITING

    City of Saint Peters, Missouri, 63376, United States

    Contact Email: •••••@•••••

  • Siteman Cancer Center at West County Hospital

    RECRUITING

    Creve Coeur, Missouri, 63141, United States

    Contact Email: •••••@•••••

  • Siteman Cancer Center-South County

    RECRUITING

    St Louis, Missouri, 63129, United States

    Contact Email: •••••@•••••

  • State University of New York Upstate Medical University

    RECRUITING

    Syracuse, New York, 13210, United States

  • Swedish Cancer Institute-Edmonds

    RECRUITING

    Edmonds, Washington, 98026, United States

  • Swedish Cancer Institute-Issaquah

    RECRUITING

    Issaquah, Washington, 98029, United States

  • Swedish Medical Center-First Hill

    RECRUITING

    Seattle, Washington, 98122, United States

  • The James Graham Brown Cancer Center at University of Louisville

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    RECRUITING

    Brighton, Michigan, 48114, United States

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    RECRUITING

    Canton, Michigan, 48188, United States

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    RECRUITING

    Chelsea, Michigan, 48118, United States

  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

    RECRUITING

    Ypsilanti, Michigan, 48197, United States

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    RECRUITING

    Pontiac, Michigan, 48341, United States

  • Trinity Health Saint Mary Mercy Livonia Hospital

    RECRUITING

    Livonia, Michigan, 48154, United States

  • Tufts Medical Center

    RECRUITING

    Boston, Massachusetts, 02111, United States

  • University of Alabama at Birmingham Cancer Center

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Kansas Cancer Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Kansas Clinical Research Center

    RECRUITING

    Fairway, Kansas, 66205, United States

  • University of Kansas Hospital-Indian Creek Campus

    RECRUITING

    Overland Park, Kansas, 66211, United States

  • University of Kansas Hospital-Westwood Cancer Center

    RECRUITING

    Westwood, Kansas, 66205, United States

  • University of Kentucky/Markey Cancer Center

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Rochester

    RECRUITING

    Rochester, New York, 14642, United States

  • UofL Health Medical Center Northeast

    RECRUITING

    Louisville, Kentucky, 40245, United States

    Contact Email: •••••@•••••

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

    Contact Email: •••••@•••••

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Other studies related to the condition(s) this trial covers.