Experimental drug combo takes on relapsed leukemia

NCT ID NCT03983824

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

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tests a new drug called M3814 alongside three chemotherapy drugs (mitoxantrone, etoposide, and cytarabine) in 48 adults with acute myeloid leukemia that has returned or not responded to treatment. The main goal is to find the safest dose and understand side effects. Researchers hope this combination may stop cancer cells from growing.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: M3814 (a drug that may block cancer cell growth) combined with mitoxantrone, etoposide, and cytarabine (chemotherapy)
What this could lead to: If it works, this could point toward a new treatment option for patients whose AML has returned or not responded to standard therapy.
What could go wrong: This is an early phase 1 trial with only 48 participants, focused on safety and dosing. It is too small to prove effectiveness, and the combination may cause significant side effects.

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

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

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

RECURRENT ACUTE MYELOID LEUKEMIA REFRACTORY ACUTE MYELOID LEUKEMIA

Contacts and locations

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States
City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States
Keck Medical Center of USC Pasadena

Pasadena, California, 91105, United States
Los Angeles General Medical Center

Los Angeles, California, 90033, United States
Mount Sinai Hospital

New York, New York, 10029, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442, United States
UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, 33324, United States
USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States
USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, 92663, United States
University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States
University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, 45219, United States
University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, 45069, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

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