About this trial

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.

Eligibility criteria

Qualifiers

Participants must have been registered to Master Screening and Re-Assessment Protocol, MYELOMATCH, prior to consenting to this study. Participants must have been assigned to this clinical trial, via MATCHBox, prior to registration to this study.

Note: Pre-enrollment/diagnosis labs must have already been performed under MYELOMATCH

Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) per World Health Organization (WHO) criteria

Participants must have high-risk (adverse) AML per European LeukemiaNet (ELN) 2017 criteria

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Azacitidine
  • Biospecimen Collection
  • Bone Marrow Aspiration
  • Cytarabine
  • Daunorubicin Hydrochloride
  • Echocardiography Test
  • Liposome-encapsulated Daunorubicin-Cytarabine
  • Multigated Acquisition Scan
  • Venetoclax

Treatment groups

335 Participants
are divided into 5 treatment groups

Locations

221
Canada
Arthur J E Child Comprehensive Cancer CentreT2N 5G2, CalgaryAlberta, Canada
University of Alberta HospitalT6G 2B7, EdmontonAlberta, Canada
CancerCare ManitobaR3E 0V9, WinnipegManitoba, Canada
QEII Health Sciences Centre/Nova Scotia Health AuthorityB3H 2Y9, HalifaxNova Scotia, Canada

Sponsors and collaborators

National Cancer Institute (NCI)

Lead sponsor