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Chemotherapy

Screening Tool for Myeloid Cancer

Phase 2
Recruiting
Led By Jerald P Radich
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be >= 18 years of age.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 72 hours of mdnet receipt of specimens for initial therapy or within 10 days for subsequent therapy
Awards & highlights

Summary

This trial is using a screening tool and specific laboratory tests to help patients with myeloid cancer (acute myeloid leukemia or myelodysplastic syndrome) enroll in clinical trials. The

Who is the study for?
This trial is for adults suspected to have untreated acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), without a history of other related blood disorders. Participants must be willing to submit bone marrow and blood specimens, consent to specimen banking, and sign an informed consent form.
What is being tested?
The MyeloMATCH trial uses marker testing on patients' bone marrow and blood to match them with specific drug treatment trials targeting their cancer type or continue standard care. It includes various interventions like chemotherapy drugs, biopsies, scans, and biospecimen collection.
What are the potential side effects?
Potential side effects may include reactions from biopsies such as pain or bleeding; chemotherapy-related issues like nausea, fatigue, hair loss; organ function changes due to medication; and risks associated with anesthesia during procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 72 hours of mdnet receipt of specimens for initial therapy or within 10 days for subsequent therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 72 hours of mdnet receipt of specimens for initial therapy or within 10 days for subsequent therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Timing of treatment Substudy or Tier Advancement Pathway (TAP) assignment
Secondary outcome measures
Adverse events
Assignment to higher tier treatment substudies within myeloMATCH
Minimal residual disease (MRD) response
+6 more

Trial Design

19Treatment groups
Experimental Treatment
Active Control
Group I: TAP (SOC treatment, mutation carrier screening)Experimental Treatment2 Interventions
Patients continue SOC treatment and undergo continued bone marrow aspiration and blood collection for possible future substudy assignment.
Group II: Screening (mutation carrier screening)Experimental Treatment1 Intervention
Patients undergo bone marrow aspiration and collection of blood on study. Patients' bone marrow and blood specimens undergo rapid genetic testing. Patients are then assigned to a specific substudy containing a therapy targeted to the patient's mutational profile. If there is no targetable mutation, the patient is placed on a substudy testing novel combinations that do not contain a target-specific drug. Patients who are not eligible for any MYELOMATCH substudy are assigned to TAP.
Group III: MM2YA-EA01 Arm D (azacitidine, venetoclax)Experimental Treatment5 Interventions
Patients receive azacitidine IV or SC and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
Group IV: MM2YA-EA01 Arm C (Vyxeos, venetoclax)Experimental Treatment5 Interventions
Patients receive Vyxeos IV and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
Group V: MM2YA-EA01 Arm B (cytarabine, venetoclax)Experimental Treatment5 Interventions
Patients receive cytarabine IV and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
Group VI: MM1YA-S01 Arm V (Vyxeos, venetoclax)Experimental Treatment6 Interventions
Patients receive daunorubicin and cytarabine liposome IV over 90 minutes on days 1, 3, and 5 and venetoclax PO on days 1-14 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of daunorubicin and cytarabine liposome IV over 90 minutes on days 1 and 3 and venetoclax PO on days 1-7. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
Group VII: MM1YA-S01 Arm IV (Vyxeos)Experimental Treatment5 Interventions
Patients receive daunorubicin and cytarabine liposome IV over 90 minutes on days 1, 3, and 5 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of daunorubicin and cytarabine liposome IV over 90 minutes on days 1 and 3. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
Group VIII: MM1YA-S01 Arm III (azacitidine, venetoclax)Experimental Treatment6 Interventions
Patients receive azacitidine SC or IV on days 1-7 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
Group IX: MM1YA-S01 Arm II (cytarabine, daunorubicin, venetoclax)Experimental Treatment7 Interventions
Patients receive cytarabine IV continuously on days 2-8 and daunorubicin IV on days 2-4 with venetoclax PO on days 1-11 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of cytarabine IV continuously on days 2-6 and daunorubicin IV on days 2-3 with venetoclax PO on days 1-8. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
Group X: MM1YA-CTG01 Arm II (azacitidine, venetoclax)Experimental Treatment4 Interventions
Patients receive azacitidine IV or SC and venetoclax PO on study and undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.
Group XI: MM1YA-CTG01 Arm I (daunorubicin, cytarabine, venetoclax)Experimental Treatment5 Interventions
Patients receive daunorubicin IV, cytarabine IV, and venetoclax PO on study and undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.
Group XII: MM1OA-EA02 Regimen 3 (azacitidine, venetoclax, gilteritinib)Experimental Treatment5 Interventions
INDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax PO on days 1-28, and gilteritinib PO on days 8-21 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-5, venetoclax PO on days 1-14 and gilteritinib PO on days 8-21 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.
Group XIII: MM1OA-EA02 Regimen 2 (azacitidine, venetoclax, gilteritinib)Experimental Treatment5 Interventions
INDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax and gilteritinib PO on days 1-28 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-5, venetoclax PO on days 1-7 and gilteritinib PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.
Group XIV: MM1OA-EA02 Regimen 1 (azacitidine, venetoclax)Experimental Treatment4 Interventions
INDUCTION: Patients receive azacitidine IV or SC on days 1-7 of each cycle and venetoclax PO on days 1-28 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.
Group XV: MM1MDS-A01 Arm B (ASTX727, enasidenib)Experimental Treatment4 Interventions
Patients receive ASTX727 PO QD on days 1-5 and enasidenib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience CR, PR, or SD any time after 4 cycles of treatment may be reassessed in order to go to a higher myeloMATCH tier assignment or to TAP. Patients also undergo bone marrow biopsy and aspiration throughout the study. Patients may also undergo optional buccal swab on study, and/or optional additional bone marrow aspiration and blood sample collection on study and at disease progression.
Group XVI: MM1MDS-A01 Arm A (ASTX727)Active Control3 Interventions
Patients receive ASTX727 PO QD on days 1-5 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who do not achieve a CR, CRL, or CRh at the end of cycle 6 may cross-over to Arm B. Patients who experience CR, PR, or stable disease (SD) any time after 4 cycles of treatment may be reassessed in order to go to a higher myeloMATCH tier assignment or to TAP. Patients also undergo bone marrow biopsy and aspiration throughout the study. Patients may also undergo optional buccal swab on study, and/or optional additional bone marrow aspiration and blood sample collection on study and at disease progression.
Group XVII: MM1YA-S01 Arm I (cytarabine, daunorubicin)Active Control6 Interventions
Patients receive cytarabine IV continuously on days 1-7 and daunorubicin IV on days 1-3 per standard approach of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of cytarabine IV continuously on days 1-5 and daunorubicin IV on days 1-2. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
Group XVIII: MM2YA-EA01 Arm A (cytarabine)Active Control4 Interventions
Patients receive cytarabine IV on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
Group XIX: MM1YA-CTG01 Arm III (daunorubicin, cytarabine)Active Control4 Interventions
Patients receive daunorubicin IV and cytarabine IV on study and undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gilteritinib
2014
Completed Phase 2
~560
Echocardiography
2013
Completed Phase 4
~11580
Daunorubicin Hydrochloride
2011
Completed Phase 3
~5330
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Cytarabine
2016
Completed Phase 3
~3330
Enasidenib
2020
Completed Phase 2
~560
Biospecimen Collection
2004
Completed Phase 3
~2020
Liposome-encapsulated Daunorubicin-Cytarabine
2016
Completed Phase 2
~100
Multigated Acquisition Scan
2015
Completed Phase 3
~270
Biopsy
2014
Completed Phase 4
~1090
Azacitidine
2012
Completed Phase 3
~1440
Venetoclax
2019
Completed Phase 3
~2200

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,001,000 Total Patients Enrolled
Jerald P RadichPrincipal InvestigatorSWOG Cancer Research Network
~1333 spots leftby May 2029
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