Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)

Summary

This phase II MyeloMATCH treatment trial tests whether the standard approach of cytarabine and daunorubicin in comparison to the following experimental regimens works to shrink cancer in patients with high risk acute myeloid leukemia (AML): 1) daunorubicin and cytarabine liposome alone; 2) cytarabine and daunorubicin with venetoclax; 3) azacitidine and venetoclax; 4) daunorubicin and cytarabine liposome and venetoclax. "High-risk" refers to traits that have been known to make the AML harder to treat. Cytarabine is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in the body. Daunorubicin is in a class of medications called anthracyclines. It also works by slowing or stopping the growth of cancer cells in the body. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. There is evidence that these newer experimental treatment regimens may work better in getting rid of more AML compared to the standard approach of cytarabine and daunorubicin.

Conditions

• Acute Myeloid Leukemia
• Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
• Acute Myeloid Leukemia Post Cytotoxic Therapy
• Acute Myeloid Leukemia, Myelodysplasia-Related

Interventions

DRUG

Azacitidine

Given SC or IV

PROCEDURE

Biospecimen Collection

Undergo collection of blood

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

DRUG

Cytarabine

Given IV

DRUG

Daunorubicin Hydrochloride

Given IV

PROCEDURE

Echocardiography Test

Undergo ECHO

DRUG

Liposome-encapsulated Daunorubicin-Cytarabine

Given IV

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

DRUG

Venetoclax

Given PO

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Paul J Shami · SWOG Cancer Research Network

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

59 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-25

Primary Completion

2027-03-31

Completion

2027-03-31

FDA Drug

Yes

Countries

• United States
• Canada
• Puerto Rico

Study Locations