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Testing the Investigational Medication Combination of Azacitidine, Venetoclax, and Quizartinib Compared to the Usual Treatment of Cytarabine, Daunorubicin, and Quizartinib for Patients With FLT3-ITD Mutant Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)

ConditionAcute Myeloid Leukemia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-59
SponsorNational Cancer Institute (NCI)

About this trial

This phase II MyeloMATCH treatment trial compares the combination of azacitidine, venetoclax and quizartinib to the standard treatment of cytarabine, daunorubicin and quizartinib for the treatment of patients with FLT3-ITD mutant acute myeloid leukemia. Azacitidine and quizartinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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. Chemotherapy drugs, such as cytarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving azacitidine, venetoclax and quizartinib may be more effective than giving cytarabine, daunorubicin and quizartinib for the treatment of patients with FLT3-ITD mutant acute myeloid leukemia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient must be ≥ 18 and ≤ 59 years of age

Patient must be assigned to this protocol by the MYELOMATCH Protocol

Patient must have newly diagnosed acute myeloid leukemia (AML) with FLT3 ITD mutation as assessed by central myeloMATCH testing with variant allele frequency (VAF) over 5%

Patient must not have any contraindications to the conventional chemotherapy used in this study

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Azacitidine

    Drug

    Given IV or SC

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bone Marrow Aspiration

    Procedure/Surgery

    Undergo bone marrow aspiration

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo bone marrow biopsy

  • Cytarabine

    Drug

    Given IV

  • Daunorubicin

    Drug

    Given IV

  • Echocardiography Test

    Procedure/Surgery

    Undergo echocardiography

  • Multigated Acquisition Scan

    Procedure/Surgery

    Undergo MUGA scan

  • Quizartinib

    Drug

    Given PO

  • Venetoclax

    Drug

    Given PO

Treatment groups

122 Participants
are divided into 2 treatment groups
Group A: Arm A (cytarabine, daunorubicin, quizartinib)Experimental treatment 8 interventions
Group B: Arm B (azacitidine, venetoclax, quizartinib)Experimental treatment 8 interventions

Trial outcomes

Primary outcomes

1

Rate of measurable residual disease (MRD) negative complete response (CR)

As measured by multiparameter flow cytometry.

Time frame
After completion of 2 treatment cycles (cycle length = 28 days)

Secondary outcomes

1

Rate of MRD negative CR/complete remission incomplete hematologic recovery (CRi)

Time frame
Up to 5 years
2

MRD negative CR

Measured by Molecular Diagnostic Network next generation sequencing assay.

Time frame
Up to 5 years
3

MRD negative composite complete response

Time frame
Up to 5 years
4

Event free survival

Will be calculated using the Kaplan-Meier method.

Time frame
From randomization to failure to achieve CR/CRi, or to relapse after CR/CRi or to death in remission, assessed up to 5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: