Now Enrolling: This myeloMATCH trial is testing a new treatment for patients with acute myeloid leukemia that has a FLT3-ITD or D835 mutation

The ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) has opened its first treatment trial as part of the myeloMATCH precision medicine study platform. MyeloMATCH is a group of clinical trials for people with acute myeloid leukemia (AML) or myelodysplastic syndromes. These trials test new precision medicine treatments for patients with myeloid cancers, from diagnosis through multiple stages of their treatment journey. MyeloMATCH opened in May 2024, and currently has three approved treatment trials available across the National Clinical Trials Network, with more to come.

Study MM1OA-EA02 is one of the three trials. It is testing a new treatment approach for patients with newly diagnosed AML, an aggressive and fast-growing cancer that affects a person’s bone marrow and blood. Additionally, it is specifically for patients who are age 60 or older and whose cancer harbors a FLT3-ITD or D835 mutation. Research suggests that older patients with these mutations may benefit from the addition of a type of drug called a FLT3 tyrosine kinase inhibitor (TKI) to the usual treatment. This study is comparing the usual combination treatment of azacitidine (ay-zuh-SY-tih-deen) chemotherapy and a drug called venetoclax (veh-NEH-toh-klax) to the triple combination treatment of azacitidine, venetoclax, and a FLT3 TKI called gilteritinib (GIL-teh-RIH-tih-nib).

The goal of treatment for AML is to put the leukemia into complete remission as quickly as possible (where the bone marrow and blood cell counts return to normal). Researchers are trying to find out if adding the drug gilteritinib can lead to a higher portion of AML patients achieving a complete remission compared to the usual approach.

Adults age 60 or older who have been diagnosed with AML may be eligible for the study. Patients younger than 60 may be eligible if their treating physician decides they would be better served by a treatment that includes azacitidine chemotherapy (instead of the more intensive cytarabine [sy-TAYR-uh-been]-based chemotherapy).

Doctors aim to enroll a total of 147 patients—and patients must first enroll in the myeloMATCH screening protocol to help determine eligibility. Patients must have AML that harbors a FLT3-ITD or D835 mutation.

Participants who match to the MM1OA-EA02 treatment trial will be randomly assigned by a computer to one of three study groups. Each group will consist of approximately 49 participants.

• Group 1: Patients will receive the usual treatment of azacitidine (by injection into a vein in the arm or just beneath the skin) and venetoclax (a tablet taken daily by mouth)
• Group 2: Patients will receive azacitidine (via injection), venetoclax (via daily tablet), and gilteritinib (also a daily tablet taken by mouth)
• Group 3: Patients will receive azacitidine (via injection) first; then, starting on day 8 of the treatment cycle, they will also receive venetoclax (via tablet) and gilteritinib (via tablet)

Each treatment cycle lasts 28 days. The primary aim of the trial is to compare the number of patients in each group who go into complete remission within four cycles of therapy.

It is common for patients with AML to stay on treatment after initial therapy to keep the cancer under control. In this trial, patients can stay on study treatment for a maximum of 24 cycles (2 years).

After patients finish the study treatment, their doctor will continue to monitor them for a total of 10 years from the time they entered the trial. While long-term follow-up is typical for all patients with AML, the participants in this trial will contribute important information to help researchers in the myeloMATCH precision medicine initiative better understand this disease.

This phase 2 treatment trial is led by Jessica K. Altman, MD, of Northwestern University/the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

Learn more about MM1OA-EA02 at ecog-acrin.org.

Learn more about the myeloMATCH screening protocol and additional treatment trials at swog.org.