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Acute Myeloid LeukemiaGeneticsCancerDrugProcedurePhase 2

What this study is

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.

What's being tested

  • Azacitidine

    Intervention · DRUG

    Given SC or IV

  • Biospecimen Collection

    Intervention · PROCEDURE

    Undergo collection of blood

  • Bone Marrow Aspiration

    Intervention · PROCEDURE

    Undergo bone marrow aspiration

  • Cytarabine

    Intervention · DRUG

  • Daunorubicin Hydrochloride

    Intervention · DRUG

  • Echocardiography Test

    Intervention · PROCEDURE

    Undergo ECHO

  • Liposome-encapsulated Daunorubicin-Cytarabine

    Intervention · DRUG

  • Multigated Acquisition Scan

    Intervention · PROCEDURE

    Undergo MUGA

  • Venetoclax

    Intervention · DRUG

    Given PO

All of Cytarabine, Daunorubicin Hydrochloride, Liposome-encapsulated Daunorubicin-Cytarabine

Given IV

Study details

Official title
A Randomized Phase II Study Comparing Cytarabine + Daunorubicin (7 + 3) vs (Daunorubicin and Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, Azacitidine + Venetoclax, and (Daunorubicin and Cytarabine) Liposome + Venetoclax in Patients Aged 59 or Younger Who Are Considered High-Risk (Adverse) Acute Myeloid Leukemia As Determined by MYELOMATCH; A MYELOMATCH SubStudy
Sponsor
National Cancer Institute (NCI)
Conditions
Acute Myeloid Leukemia · Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm · Acute Myeloid Leukemia Post Cytotoxic Therapy · Acute Myeloid Leukemia, Myelodysplasia-Related
Enrolling
335 people
Starts
2024-09-25
Est. completion
2027-03-31
Design
Open-label, randomized, parallel groups, Phase 2
Record
View on ClinicalTrials.gov ↗