Testing Allogeneic Hematopoietic Stem Cell against a placebo for acute myeloid leukemia
Official title: MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
Master Screening and Reassessment Protocol (MSRP) for the NCI MyeloMATCH Clinical Trials
Interventions
Allogeneic Hematopoietic Stem Cell Transplantation
Given IV
Azacitidine
Given IV or SC
Best Practice
Receive SOC treatment
Biopsy Procedure
Undergo biopsy
Biospecimen Collection
Undergo collection of blood, urine, and/or buccal swab samples
Bone Marrow Aspiration
Undergo bone marrow aspiration
Bone Marrow Biopsy
Undergo bone marrow biopsy
Busulfan
Given IV
Chest Radiography
Undergo chest x-ray
Computed Tomography
Undergo CT
Cytarabine
Given
Daunorubicin Hydrochloride
Given IV
Decitabine and Cedazuridine
Given PO
Echocardiography Test
Undergo ECHO
Emavusertib
Given PO
Enasidenib
Given PO
Epoetin Alfa
Given SC
Fludarabine
Given IV
Gemtuzumab Ozogamicin
Given IV
Gilteritinib
Given PO
Liposome-encapsulated Daunorubicin-Cytarabine
Given IV
Luspatercept
Given SC
Melphalan
Given IV
Multigated Acquisition Scan
Undergo MUGA
Mutation Carrier Screening
Undergo rapid genetic testing
Olutasidenib
Given PO
Placebo Administration
Given PO
Positron Emission Tomography
Undergo PET
Total-Body Irradiation
Undergo total body irradiation
Venetoclax
Given PO
Canadian Sites (11)
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
QEII Health Sciences Centre/Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada
Ottawa Hospital and Cancer Center-General Campus
Ottawa, Ontario, Canada
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada
CSSS Champlain-Charles Le Moyne
Greenfield Park, Quebec, Canada
CIUSSSEMTL-Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Eligibility Criteria
See who this study is looking for16 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 controlControl groupThe group a new treatment is measured against.Read more → the white blood cell count (WBC) is allowed.
- +Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more →. Participants must not be currently receiving any cytarabine-containing therapy other than up to 1 g/m\^2 of cytarabine, which is allowed for urgent cytoreduction.
- +Participants are allowed prior use of hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide, with a maximum limit of 1 month of exposure.
- +Note: Participants receiving hydroxyurea prior to treatment substudy or TAP assignment must agree to discontinue hydroxyurea within 24 hours before beginning substudy or TAP treatment.
- +Participants must not have a prior or concurrent malignancy that requires concurrent anti-cancer therapy
- +Note: active hormonal therapy is allowed
- +Participants must have a Zubrod Performance Status evaluation within 28 days prior to registration.
- +Participants must agree to have translational medicine specimens submitted.
- +Participants must be offered the opportunity to participate in specimen banking.
- +Note: Specimens must be collected and submitted following the initial paper-based process and subsequently via the Precision Medicine Specimen Tracking Forms in Medidata Rave instance for the MyeloMATCH MSRP.
- +Participants must be informed of the investigational nature of this study and must sign and give informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → in accordance with institutional and federal guidelines.
- +Note: As a part of the Oncology Patient EnrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review boardResearch Ethics Board (REB)The independent committee that must approve a study before it can run.Read more → approval for this study has been entered in the system.
- +The master screeningScreeningThe checks done before joining, to see whether a study fits.Read more → and reassessment protocolProtocolThe detailed plan a study must follow.Read more → (MSRP) should only be used in sites where the relevant AML treatment substudies are open or if the siteTrial siteA hospital or clinic where a study is actually run.Read more → is willing to follow the MSRP Tier Advancement Pathway (TAP) for patients in the event that the site does not have the relevant study open and transfer to another site that does have the study open. For example, if a site does not have a myeloMATCH Tier 1 study for older AML open for enrollmentRecruitingThe study is currently looking for participants.Read more →, such older AML patients should only be consented for the MSRP if the site is willing to treat the patient with standard of careStandard of careThe treatment normally given for a condition outside a study.Read more → on TAP or is willing to transfer the patient to a center with a study open that the patient would otherwise match to.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to detect a condition before symptoms appear.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
What is being given or done in this study: Allogeneic Hematopoietic Stem Cell Transplantation, Azacitidine, Best Practice, Biopsy Procedure, and 26 more.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
One group receives an existing treatment, so the two can be compared.
There are 39 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 2,000 people.
The study is currently expected to finish around May 2029.
The main measurement is taken over: Within 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Timing of treatment Substudy or Tier Advancement Pathway (TAP) assignment — measured over Within 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05564390 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Allogeneic Hematopoietic Stem Cell TransplantationProcedure
Given IV
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About AzacitidineDrug
Given IV or SC
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Best PracticeOther
Receive SOC treatment
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Biopsy ProcedureProcedure
Undergo biopsy
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Biospecimen CollectionProcedure
Undergo collection of blood, urine, and/or buccal swab samples
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Bone Marrow AspirationProcedure
Undergo bone marrow aspiration
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Bone Marrow BiopsyProcedure
Undergo bone marrow biopsy
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About BusulfanDrug
Given IV
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Chest RadiographyProcedure
Undergo chest x-ray
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Computed TomographyProcedure
Undergo CT
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About CytarabineDrug
Given
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Daunorubicin HydrochlorideDrug
Given IV
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Decitabine and CedazuridineDrug
Given PO
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Echocardiography TestProcedure
Undergo ECHO
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About EmavusertibBiological
Given PO
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About EnasidenibDrug
Given PO
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Epoetin AlfaBiological
Given SC
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About FludarabineDrug
Given IV
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Gemtuzumab OzogamicinDrug
Given IV
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About GilteritinibDrug
Given PO
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Liposome-encapsulated Daunorubicin-CytarabineDrug
Given IV
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About LuspaterceptBiological
Given SC
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About MelphalanDrug
Given IV
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Multigated Acquisition ScanProcedure
Undergo MUGA
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Mutation Carrier ScreeningProcedure
Undergo rapid genetic testing
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About OlutasidenibDrug
Given PO
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Placebo AdministrationDrug
Given PO
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Positron Emission TomographyProcedure
Undergo PET
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Total-Body IrradiationRadiation
Undergo total body irradiation
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
About VenetoclaxDrug
Given PO
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Within 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy.
The study as a whole is currently expected to finish around 2029-05-15.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 2,000 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 52 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Winnipeg, Manitoba, Canada; Halifax, Nova Scotia, Canada; Hamilton, Ontario, Canada; Ottawa, Ontario, Canada, and 46 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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).
Other Sites (53)
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States
Cancer Hematology Centers - Flint
Flint, Michigan, United States
Genesee Hematology Oncology PC
Flint, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Allegiance Health
Jackson, Michigan, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, United States
Henry Ford Medical Center-Columbus
Novi, Michigan, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Essentia Health - Deer River Clinic
Deer River, Minnesota, United States
And 33 more sites worldwide.
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.