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Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)

ConditionsAcute Myeloid LeukemiaAcute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative NeoplasmAcute Myeloid Leukemia Post Cytotoxic TherapyAcute Myeloid Leukemia, Myelodysplasia-Related
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-59
SponsorNational Cancer Institute (NCI)

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Azacitidine

    Drug

    Given SC or IV

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood

  • Bone Marrow Aspiration

    Procedure/Surgery

    Undergo bone marrow aspiration

  • Cytarabine

    Drug

    Given IV

  • Daunorubicin Hydrochloride

    Drug

    Given IV

  • Echocardiography Test

    Procedure/Surgery

    Undergo ECHO

  • Liposome-encapsulated Daunorubicin-Cytarabine

    Drug

    Given IV

  • Multigated Acquisition Scan

    Procedure/Surgery

    Undergo MUGA

  • Venetoclax

    Drug

    Given PO

Treatment groups

335 Participants
are divided into 5 treatment groups
Group A: Arm I (cytarabine, daunorubicin)Active comparator 6 interventions
Group B: Arm II (cytarabine, daunorubicin, venetoclax)Experimental treatment 7 interventions
Group C: Arm III (azacitidine, venetoclax)Experimental treatment 5 interventions
Group D: Arm IV (daunorubicin and cytarabine liposome)Experimental treatment 5 interventions
Group E: Arm V (daunorubicin and cytarabine liposome, venetoclax)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Minimal residual disease (MRD) response (Arm 1, 2, 4 and 5)

Will be analyzed using intent-to-treat (ITT) principles.

Time frame
After induction (28 days) or re-induction (56 days)
2

MRD response (Arm 3)

Will be analyzed using ITT principles.

Time frame
After two cycles of therapy (56 days)

Secondary outcomes

1

Early mortality

Will be assessed by death due to any cause between experimental arms and the 7+3 arm will be reported for each arm every data and safety monitoring committee (DSMC) cycle. Fisher's exact will be used to compare observed rates. A one-sided p-value \< 0.05 indicating increased early mortality rates in an experimental arm will be a threshold for termination of accrual to an arm due to increased early mortality.

Time frame
On or before day 28
2

Time to count recovery

Will be reported every DSMC cycle for the 7+3+venetoclax, (daunorubicin and cytarabine) liposome+venetoclax, and 7+3 arms. Median time to count recovery more than 7 days longer on either of the 7+3+venetoclax and (daunorubicin and cytarabine liposome+venetoclax arms compared to the 7+3 arm will be used a threshold to terminate accrual to an arm due to increased toxicity.

Time frame
After cycle 1 and cycle 2
3

Event-free survival

Will be estimated using the Kaplan-Meier method.

Time frame
From randomization to the first of: primary refractory disease; progressive disease; off protocol therapy without complete remission (CR) or CR with incomplete count recovery (CRi); relapse from CR or CRi, or death from any cause, assessed up to 5 years
4

Relapse-free survival

Defined for only patients achieving CR, or CRi. Will be estimated using the Kaplan-Meier method.

Time frame
From the date of achievement of a remission until the date of relapse or death from any cause, assessed up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov
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