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MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)

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

About this trial

This MyeloMATCH Master Screening and Reassessment Protocol (MSRP) evaluates the use of a screening tool and specific laboratory tests to help improve participants' ability to register to clinical trials throughout the course of their myeloid cancer (acute myeloid leukemia or myelodysplastic syndrome) treatment. This study involves testing patients' bone marrow and blood for certain biomarkers. A biomarker (sometimes called a marker) is any molecule in the body that can be measured. Doctors look at markers to learn what is happening in the body. Knowing about certain markers can give doctors more information about what is driving the cancer and how to treat it. Testing patients' bone marrow and blood will show doctors if patients have markers that specific drugs can target. The marker testing in this study will let doctors know if they can match patients with a treatment study (myeloMATCH clinical trial) that tests treatment for the type of cancer they have or continue standard of care treatment with their doctor on the Tier Advancement Pathway (TAP).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must be suspected to have previously untreated acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Participants with AML cannot have a history of previously treated myeloproliferative neoplasms (MPN) or MDS.

Participants must be >= 18 years of age.

Participants must not have received prior anti-cancer therapy for AML or MDS.

Note: Hydroxyurea to control the white blood cell count (WBC) is allowed.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Allogeneic Hematopoietic Stem Cell Transplantation

    Procedure/Surgery

    Given IV

  • Azacitidine

    Drug

    Given IV or SC

  • Azacitidine

    Drug

    Given IV or SC

  • Best Practice

    Other intervention

    Receive SOC treatment

  • Biopsy Procedure

    Procedure/Surgery

    Undergo biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood, urine, and/or buccal swab samples

  • Bone Marrow Aspiration

    Procedure/Surgery

    Undergo bone marrow aspiration

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo bone marrow biopsy

  • Busulfan

    Drug

    Given IV

  • Chest Radiography

    Procedure/Surgery

    Undergo chest x-ray

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Cytarabine

    Drug

    Given IV

  • Daunorubicin

    Drug

    Given IV

  • Daunorubicin Hydrochloride

    Drug

    Given IV

  • Decitabine and Cedazuridine

    Drug

    Given PO

  • Echocardiography Test

    Procedure/Surgery

    Undergo ECHO

  • Emavusertib

    Biological/Vaccine

    Given PO

  • Enasidenib

    Drug

    Given PO

  • Epoetin Alfa

    Biological/Vaccine

    Given SC

  • Fludarabine

    Drug

    Given IV

  • Gemtuzumab Ozogamicin

    Drug

    Given IV

  • Gilteritinib

    Drug

    Given PO

  • Liposome-encapsulated Daunorubicin-Cytarabine

    Drug

    Given IV

  • Luspatercept

    Biological/Vaccine

    Given SC

  • Melphalan

    Drug

    Given IV

  • Multigated Acquisition Scan

    Procedure/Surgery

    Undergo MUGA

  • Mutation Carrier Screening

    Procedure/Surgery

    Undergo rapid genetic testing

  • Olutasidenib

    Drug

    Given PO

  • Placebo Administration

    Drug

    Given PO

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET

  • Quizartinib

    Drug

    Given PO

  • Total-Body Irradiation

    Radiation

    Undergo total body irradiation

  • Venetoclax

    Drug

    Given PO

Treatment groups

2,000 Participants
are divided into 41 treatment groups

41

Treatment groups

See each treatment group below.

Group A: MM1MDS-A01 Regimen 1 (ASTX727)Active comparator 4 interventions
Group B: MM1MDS-A01 Regimen 2 (ASTX727, enasidenib)Experimental treatment 5 interventions
Group C: MM1MDS-CTG02 Arm 1 (Luspatercept)Experimental treatment 3 interventions
Group D: MM1MDS-CTG02 Arm 2 (Luspatercept with epoetin alfa)Experimental treatment 4 interventions
Group E: MM1MDS-CTG02 Arm 3 (Luspatercept and emavusertib)Experimental treatment 4 interventions
Group F: MM1OA-EA02 Regimen 1 (azacitidine, venetoclax)Experimental treatment 4 interventions
Group G: MM1OA-EA02 Regimen 2 (azacitidine, venetoclax, gilteritinib)Experimental treatment 5 interventions
Group H: MM1OA-EA02 Regimen 3 (azacitidine, venetoclax, gilteritinib)Experimental treatment 5 interventions
Group I: MM1OA-MDS-A05 Cohort A, Arm 1 (ASTX727, venetoclax)Active comparator 5 interventions
Group J: MM1OA-MDS-A05 Cohort A,Arm 2 (ASTX727,venetoclax,olutasidenib)Experimental treatment 6 interventions
Group K: MM1OA-MDS-A05 Cohort B, Arm 3 (ASTX727, olutasidenib)Experimental treatment 5 interventions
Group L: MM1OA-MDS-A05 Cohort B, Arm 4 (ASTX727)Active comparator 4 interventions
Group M: MM1OA-MDS-A05 Cohort C (olutasidenib)Experimental treatment 4 interventions
Group N: MM1OA-S03 Arm 1 (ASTX727, venetoclax)Active comparator 5 interventions
Group O: MM1OA-S03 Arm 2 (ASTX727, venetoclax, enasidenib)Experimental treatment 6 interventions
Group P: MM1OA-S04 Arm 1 (ASTX727 with standard duration venetoclax)Active comparator 4 interventions
Group Q: MM1OA-S04 Arm 2 (ASTX727 with shorter duration venetoclax)Experimental treatment 4 interventions
Group R: MM1YA-A04 Regimen 1 (gemtuzumab ozogamicin, chemotherapy)Active comparator 8 interventions
Group S: MM1YA-A04 Regimen 2 (venetoclax, chemotherapy)Experimental treatment 8 interventions
Group T: MM1YA-CTG01 Arm I (daunorubicin, cytarabine, venetoclax)Experimental treatment 7 interventions
Group U: MM1YA-CTG01 Arm II (azacitidine, venetoclax)Experimental treatment 6 interventions
Group V: MM1YA-CTG01 Arm III (daunorubicin, cytarabine)Active comparator 6 interventions
Group W: MM1YA-EA05 Arm A (cytarabine, daunorubicin, quizartinib)Experimental treatment 8 interventions
Group X: MM1YA-EA05 Arm B (azacitidine, venetoclax, quizartinib)Experimental treatment 8 interventions
Group Y: MM1YA-S01 Arm I (cytarabine, daunorubicin)Active comparator 6 interventions
Group Z: MM1YA-S01 Arm II (cytarabine, daunorubicin, venetoclax)Experimental treatment 7 interventions
Group [: MM1YA-S01 Arm III (azacitidine, venetoclax)Experimental treatment 6 interventions
Group \: MM1YA-S01 Arm IV (Vyxeos)Experimental treatment 5 interventions
Group ]: MM1YA-S01 Arm V (Vyxeos, venetoclax)Experimental treatment 6 interventions
Group ^: MM2YA-EA01 Arm A (cytarabine)Active comparator 4 interventions
Group _: MM2YA-EA01 Arm B (cytarabine, venetoclax)Experimental treatment 5 interventions
Group `: MM2YA-EA01 Arm C (Vyxeos, venetoclax)Experimental treatment 5 interventions
Group a: MM2YA-EA01 Arm D (azacitidine, venetoclax)Experimental treatment 5 interventions
Group b: MM3TCT-A03 Conditioning 1A (matched donors with venetoclax)Experimental treatment 12 interventions
Group c: MM3TCT-A03 Conditioning 1B (matched donors with placebo)Placebo comparator 12 interventions
Group d: MM3TCT-A03 Conditioning 2A (haplo/mismatch with venetoclax)Experimental treatment 12 interventions
Group e: MM3TCT-A03 Conditioning 2B (haplo/mismatch with placebo)Placebo comparator 11 interventions
Group f: MM3TCT-A03 Maintenance I (venetoclax)Experimental treatment 6 interventions
Group g: MM3TCT-A03 Maintenance II (placebo)Placebo comparator 5 interventions
Group h: Screening (mutation carrier screening)Experimental treatment 1 intervention
Group i: TAP (SOC treatment, mutation carrier screening)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Timing of treatment Substudy or Tier Advancement Pathway (TAP) assignment

Will evaluate the feasibility of MATCHBox generating all data needed for assignment to a myeloMATCH clinical trial or determination that no assignment is available, within 72 hours of MDNet receipt of specimens for initial therapy and within 10 days for subsequent therapy. For first treatment assignment and separately for each subsequent treatment assignments: every 50 participants for the first 250 participants and then every 100 participants thereafter, the proportion of participants (cumulative and new participants since prior analysis) with all MDNet data needed to determine a treatment assignment within 72 hours for first assignment and 10 days for subsequent assignments after the MDNet receives specimens will be tallied.

Time frame
Within 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy

Secondary outcomes

1

Time to MDNet generating all data required for treatment substudy or TAP assignment

Will be assessed within each tier of clinical trials, within each clinical basket of clinical trials, and over time (since last report and in 6 month intervals from study opening).

Time frame
Within 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy
2

Time to treatment substudy or TAP assignment

Will be assessed within each tier of clinical trials, within each clinical basket of clinical trials, and over time (since last report and in 6 month intervals from study opening).

Time frame
Within 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy
3

Percent assigned to a myeloMATCH clinical trial

Will be assessed within each tier of clinical trials, within each clinical basket of clinical trials, and over time (since last report and in 6 month intervals from study opening).

Time frame
Within 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy
4

Percent of screened participants who register to a treatment substudy

Will be assessed within each tier of clinical trials, within each clinical basket of clinical trials, and over time (since last report and in 6 month intervals from study opening).

Time frame
Within 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy

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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