Bone Marrow Aspiration Clinical Trials

Clinical trials related to Bone Marrow Aspiration Procedure

Master Screening and Reassessment Protocol (MSRP) for the NCI MyeloMATCH Clinical Trials

Status: Recruiting
Location: See all (346) locations...
Intervention Type: Procedure, Drug, Biological, Other, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

⁃ Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility. 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 consent in accordance with institutional and federal guidelines.

‣ Note: As a part of the Oncology Patient Enrollment 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 board approval for this study has been entered in the system.

• The master screening and reassessment protocol (MSRP) should only be used in sites where the relevant AML treatment substudies are open or if the site 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 enrollment, such older AML patients should only be consented for the MSRP if the site is willing to treat the patient with standard of care on TAP or is willing to transfer the patient to a center with a study open that the patient would otherwise match to.

Locations
United States
Alabama
University of Alabama at Birmingham Cancer Center
RECRUITING
Birmingham
Arkansas
University of Arkansas for Medical Sciences
RECRUITING
Little Rock
Arizona
Mayo Clinic Hospital in Arizona
RECRUITING
Phoenix
Banner University Medical Center - Tucson
RECRUITING
Tucson
University of Arizona Cancer Center-North Campus
RECRUITING
Tucson
California
Alta Bates Summit Medical Center-Herrick Campus
RECRUITING
Berkeley
Kaiser Permanente Dublin
RECRUITING
Dublin
Kaiser Permanente-Fremont
RECRUITING
Fremont
Kaiser Permanente Fresno Orchard Plaza
RECRUITING
Fresno
Kaiser Permanente-Fresno
RECRUITING
Fresno
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
RECRUITING
Irvine
Tibor Rubin VA Medical Center
ACTIVE_NOT_RECRUITING
Long Beach
Cedars Sinai Medical Center
RECRUITING
Los Angeles
Kaiser Permanente- Modesto MOB II
RECRUITING
Modesto
Kaiser Permanente-Modesto
RECRUITING
Modesto
Kaiser Permanente-Oakland
RECRUITING
Oakland
UC Irvine Health/Chao Family Comprehensive Cancer Center
RECRUITING
Orange
Kaiser Permanente-Roseville
RECRUITING
Roseville
Kaiser Permanente Downtown Commons
RECRUITING
Sacramento
Kaiser Permanente-South Sacramento
RECRUITING
Sacramento
University of California Davis Comprehensive Cancer Center
RECRUITING
Sacramento
Kaiser Permanente-San Francisco
RECRUITING
San Francisco
UCSF Medical Center-Parnassus
RECRUITING
San Francisco
Kaiser Permanente-Santa Teresa-San Jose
RECRUITING
San Jose
Kaiser Permanente San Leandro
RECRUITING
San Leandro
Kaiser San Rafael-Gallinas
RECRUITING
San Rafael
Kaiser Permanente Medical Center - Santa Clara
RECRUITING
Santa Clara
Kaiser Permanente-Santa Rosa
RECRUITING
Santa Rosa
Kaiser Permanente-South San Francisco
RECRUITING
South San Francisco
Kaiser Permanente-Vallejo
RECRUITING
Vallejo
Kaiser Permanente-Walnut Creek
RECRUITING
Walnut Creek
Connecticut
Yale University
RECRUITING
New Haven
Veterans Affairs Connecticut Healthcare System-West Haven Campus
RECRUITING
West Haven
Florida
UF Health Cancer Institute - Gainesville
RECRUITING
Gainesville
Mayo Clinic in Florida
RECRUITING
Jacksonville
Miami Cancer Institute
RECRUITING
Miami
Memorial Hospital West
RECRUITING
Pembroke Pines
Georgia
Phoebe Putney Memorial Hospital
RECRUITING
Albany
Augusta University Medical Center
RECRUITING
Augusta
Hawaii
Hawaii Cancer Care - Westridge
RECRUITING
‘aiea
Pali Momi Medical Center
RECRUITING
‘aiea
Hawaii Cancer Care Inc - Waterfront Plaza
RECRUITING
Honolulu
Kaiser Permanente Moanalua Medical Center
RECRUITING
Honolulu
Kapiolani Medical Center for Women and Children
RECRUITING
Honolulu
Straub Clinic and Hospital
RECRUITING
Honolulu
Iowa
UI Health Care Mission Cancer and Blood - Ankeny Clinic
RECRUITING
Ankeny
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
RECRUITING
Clive
Iowa Methodist Medical Center
RECRUITING
Des Moines
Mercy Medical Center - Des Moines
RECRUITING
Des Moines
UI Health Care Mission Cancer and Blood - Des Moines Clinic
RECRUITING
Des Moines
UI Health Care Mission Cancer and Blood - Laurel Clinic
RECRUITING
Des Moines
University of Iowa/Holden Comprehensive Cancer Center
RECRUITING
Iowa City
UI Healthcare Mission Cancer and Blood - Pella
RECRUITING
Pella
UI Health Care Mission Cancer and Blood - Waukee Clinic
RECRUITING
Waukee
The Iowa Clinic PC
RECRUITING
West Des Moines
Idaho
Saint Alphonsus Cancer Care Center-Boise
RECRUITING
Boise
Saint Luke's Cancer Institute - Boise
RECRUITING
Boise
Saint Alphonsus Cancer Care Center-Caldwell
RECRUITING
Caldwell
Kootenai Health - Coeur d'Alene
RECRUITING
Coeur D'alene
Saint Luke's Cancer Institute - Fruitland
RECRUITING
Fruitland
Saint Luke's Cancer Institute - Meridian
RECRUITING
Meridian
Saint Alphonsus Cancer Care Center-Nampa
RECRUITING
Nampa
Saint Luke's Cancer Institute - Nampa
RECRUITING
Nampa
Kootenai Clinic Cancer Services - Post Falls
RECRUITING
Post Falls
Kootenai Clinic Cancer Services - Sandpoint
RECRUITING
Sandpoint
Illinois
Advocate Outpatient Center - Aurora
RECRUITING
Aurora
Advocate Good Shepherd Hospital
RECRUITING
Barrington
Illinois CancerCare-Bloomington
RECRUITING
Bloomington
OSF Saint Joseph Medical Center
RECRUITING
Bloomington
Illinois CancerCare-Canton
RECRUITING
Canton
Illinois CancerCare-Carthage
RECRUITING
Carthage
Advocate Illinois Masonic Medical Center
RECRUITING
Chicago
Northwestern University
RECRUITING
Chicago
University of Chicago Comprehensive Cancer Center
RECRUITING
Chicago
University of Illinois
RECRUITING
Chicago
AMG Crystal Lake - Oncology
RECRUITING
Crystal Lake
Carle at The Riverfront
RECRUITING
Danville
Cancer Care Specialists of Illinois - Decatur
RECRUITING
Decatur
Decatur Memorial Hospital
RECRUITING
Decatur
Northwestern Medicine Cancer Center Kishwaukee
RECRUITING
Dekalb
Illinois CancerCare-Dixon
RECRUITING
Dixon
Advocate Good Samaritan Hospital
RECRUITING
Downers Grove
Carle Physician Group-Effingham
RECRUITING
Effingham
Crossroads Cancer Center
RECRUITING
Effingham
Advocate Sherman Hospital
RECRUITING
Elgin
Illinois CancerCare-Eureka
RECRUITING
Eureka
NorthShore University HealthSystem-Evanston Hospital
RECRUITING
Evanston
Illinois CancerCare-Galesburg
RECRUITING
Galesburg
Northwestern Medicine Cancer Center Delnor
RECRUITING
Geneva
NorthShore University HealthSystem-Glenbrook Hospital
RECRUITING
Glenview
Northwestern Medicine Glenview Outpatient Center
RECRUITING
Glenview
Northwestern Medicine Grayslake Outpatient Center
RECRUITING
Grayslake
Advocate South Suburban Hospital
RECRUITING
Hazel Crest
NorthShore University HealthSystem-Highland Park Hospital
RECRUITING
Highland Park
Edward Hines Jr VA Hospital
RECRUITING
Hines
Illinois CancerCare-Kewanee Clinic
RECRUITING
Kewanee
Northwestern Medicine Lake Forest Hospital
RECRUITING
Lake Forest
AMG Libertyville - Oncology
RECRUITING
Libertyville
Condell Memorial Hospital
RECRUITING
Libertyville
Illinois CancerCare-Macomb
RECRUITING
Macomb
Carle Physician Group-Mattoon/Charleston
RECRUITING
Mattoon
Loyola University Medical Center
RECRUITING
Maywood
Cancer Care Center of O'Fallon
RECRUITING
O'fallon
Advocate Christ Medical Center
RECRUITING
Oak Lawn
Advocate Outpatient Center - Oak Lawn
RECRUITING
Oak Lawn
Northwestern Medicine Orland Park
RECRUITING
Orland Park
Illinois CancerCare-Ottawa Clinic
RECRUITING
Ottawa
Advocate High Tech Medical Park
RECRUITING
Palos Heights
Advocate Lutheran General Hospital
RECRUITING
Park Ridge
Illinois CancerCare-Pekin
RECRUITING
Pekin
Illinois CancerCare-Peoria
RECRUITING
Peoria
Methodist Medical Center of Illinois
RECRUITING
Peoria
OSF Saint Francis Medical Center
RECRUITING
Peoria
Illinois CancerCare-Peru
RECRUITING
Peru
Illinois CancerCare-Princeton
RECRUITING
Princeton
Southern Illinois University School of Medicine
RECRUITING
Springfield
Springfield Clinic
RECRUITING
Springfield
Springfield Memorial Hospital
RECRUITING
Springfield
Carle Cancer Center
RECRUITING
Urbana
Northwestern Medicine Cancer Center Warrenville
RECRUITING
Warrenville
Illinois CancerCare - Washington
RECRUITING
Washington
Indiana
Indiana University/Melvin and Bren Simon Cancer Center
RECRUITING
Indianapolis
Kansas
University of Kansas Clinical Research Center
RECRUITING
Fairway
HaysMed
RECRUITING
Hays
University of Kansas Cancer Center
RECRUITING
Kansas City
Lawrence Memorial Hospital
RECRUITING
Lawrence
The University of Kansas Cancer Center - Olathe
RECRUITING
Olathe
University of Kansas Cancer Center-Overland Park
RECRUITING
Overland Park
University of Kansas Hospital-Indian Creek Campus
RECRUITING
Overland Park
Salina Regional Health Center
RECRUITING
Salina
Cotton O'Neil Cancer Center / Stormont Vail Health
SUSPENDED
Topeka
University of Kansas Health System Saint Francis Campus
SUSPENDED
Topeka
University of Kansas Hospital-Westwood Cancer Center
RECRUITING
Westwood
Kentucky
University of Kentucky/Markey Cancer Center
RECRUITING
Lexington
The James Graham Brown Cancer Center at University of Louisville
RECRUITING
Louisville
UofL Health Medical Center Northeast
RECRUITING
Louisville
Louisiana
LSU Health Baton Rouge-North Clinic
SUSPENDED
Baton Rouge
Our Lady of The Lake
RECRUITING
Baton Rouge
Our Lady of the Lake Physician Group
RECRUITING
Baton Rouge
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Dana-Farber Cancer Institute
RECRUITING
Boston
Tufts Medical Center
RECRUITING
Boston
UMass Memorial Medical Center - University Campus
RECRUITING
Worcester
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
RECRUITING
Baltimore
Walter Reed National Military Medical Center
RECRUITING
Bethesda
Maine
MaineHealth Cancer Care and IV Therapy - Brunswick
RECRUITING
Brunswick
Mid Coast Hospital
RECRUITING
Brunswick
MaineHealth Maine Medical Center - Portland
RECRUITING
Portland
MaineHealth Cancer Care and IV Therapy - South Portland
RECRUITING
South Portland
Michigan
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
RECRUITING
Ann Arbor
Trinity Health IHA Medical Group Hematology Oncology - Brighton
RECRUITING
Brighton
Trinity Health IHA Medical Group Hematology Oncology - Canton
RECRUITING
Canton
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
RECRUITING
Chelsea
Henry Ford Macomb Hospital-Clinton Township
RECRUITING
Clinton Township
Henry Ford Hospital
RECRUITING
Detroit
Wayne State University/Karmanos Cancer Institute
RECRUITING
Detroit
Weisberg Cancer Treatment Center
RECRUITING
Farmington Hills
Cancer Hematology Centers - Flint
RECRUITING
Flint
Genesee Hematology Oncology PC
SUSPENDED
Flint
Genesys Hurley Cancer Institute
RECRUITING
Flint
Hurley Medical Center
RECRUITING
Flint
Allegiance Health
RECRUITING
Jackson
Trinity Health Saint Mary Mercy Livonia Hospital
RECRUITING
Livonia
Henry Ford Medical Center-Columbus
RECRUITING
Novi
Trinity Health Saint Joseph Mercy Oakland Hospital
RECRUITING
Pontiac
Henry Ford West Bloomfield Hospital
RECRUITING
West Bloomfield
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
RECRUITING
Ypsilanti
Minnesota
Mercy Hospital
RECRUITING
Coon Rapids
Essentia Health - Deer River Clinic
RECRUITING
Deer River
Essentia Health Cancer Center
RECRUITING
Duluth
Fairview Southdale Hospital
RECRUITING
Edina
Essentia Health Hibbing Clinic
RECRUITING
Hibbing
Abbott-Northwestern Hospital
RECRUITING
Minneapolis
Mayo Clinic in Rochester
RECRUITING
Rochester
Park Nicollet Clinic - Saint Louis Park
RECRUITING
Saint Louis Park
Regions Hospital
RECRUITING
Saint Paul
United Hospital
RECRUITING
Saint Paul
Essentia Health Virginia Clinic
RECRUITING
Virginia
Missouri
Siteman Cancer Center at Saint Peters Hospital
RECRUITING
City Of Saint Peters
Siteman Cancer Center at West County Hospital
RECRUITING
Creve Coeur
Parkland Health Center - Farmington
RECRUITING
Farmington
University Health Truman Medical Center
RECRUITING
Kansas City
University of Kansas Cancer Center - Briarcliff
RECRUITING
Kansas City
University of Kansas Cancer Center - North
RECRUITING
Kansas City
University of Kansas Cancer Center - Lee's Summit
RECRUITING
Lee's Summit
Heartland Regional Medical Center
RECRUITING
Saint Joseph
Sainte Genevieve County Memorial Hospital
RECRUITING
Sainte Genevieve
Mercy Hospital South
SUSPENDED
St Louis
Missouri Baptist Medical Center
RECRUITING
St Louis
Siteman Cancer Center at Christian Hospital
RECRUITING
St Louis
Siteman Cancer Center-South County
RECRUITING
St Louis
Washington University School of Medicine
RECRUITING
St Louis
Missouri Baptist Sullivan Hospital
RECRUITING
Sullivan
BJC Outpatient Center at Sunset Hills
RECRUITING
Sunset Hills
Mississippi
Baptist Memorial Hospital and Cancer Center-Golden Triangle
RECRUITING
Columbus
Baptist Cancer Center-Grenada
RECRUITING
Grenada
Baptist Memorial Hospital and Cancer Center-Union County
RECRUITING
New Albany
Baptist Memorial Hospital and Cancer Center-Oxford
RECRUITING
Oxford
Baptist Memorial Hospital and Cancer Center-Desoto
RECRUITING
Southhaven
Montana
Community Hospital of Anaconda
RECRUITING
Anaconda
Billings Clinic Cancer Center
RECRUITING
Billings
Bozeman Health Deaconess Hospital
RECRUITING
Bozeman
Benefis Sletten Cancer Institute
RECRUITING
Great Falls
Logan Health Medical Center
RECRUITING
Kalispell
Community Medical Center
RECRUITING
Missoula
Saint Patrick Hospital - Community Hospital
RECRUITING
Missoula
North Carolina
UNC Lineberger Comprehensive Cancer Center
RECRUITING
Chapel Hill
Carolinas Medical Center/Levine Cancer Institute
RECRUITING
Charlotte
Novant Health Presbyterian Medical Center
RECRUITING
Charlotte
Duke University Medical Center
RECRUITING
Durham
East Carolina University
RECRUITING
Greenville
Novant Health New Hanover Regional Medical Center
RECRUITING
Wilmington
Novant Health Forsyth Medical Center
RECRUITING
Winston-salem
Wake Forest University Health Sciences
RECRUITING
Winston-salem
Nebraska
Nebraska Medicine-Bellevue
RECRUITING
Bellevue
Nebraska Medicine-Village Pointe
RECRUITING
Omaha
University of Nebraska Medical Center
RECRUITING
Omaha
New Hampshire
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
RECRUITING
Lebanon
New Jersey
Memorial Sloan Kettering Basking Ridge
RECRUITING
Basking Ridge
Cooper Hospital University Medical Center
RECRUITING
Camden
Saint Barnabas Medical Center
RECRUITING
Livingston
Monmouth Medical Center
RECRUITING
Long Branch
Memorial Sloan Kettering Monmouth
RECRUITING
Middletown
Memorial Sloan Kettering Bergen
RECRUITING
Montvale
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
The Valley Hospital - Luckow Pavilion
RECRUITING
Paramus
Valley Health System Ridgewood Campus
RECRUITING
Ridgewood
Community Medical Center
RECRUITING
Toms River
New Mexico
University of New Mexico Cancer Center
RECRUITING
Albuquerque
Nevada
OptumCare Cancer Care at Seven Hills
RECRUITING
Henderson
OptumCare Cancer Care at Charleston
RECRUITING
Las Vegas
OptumCare Cancer Care at Fort Apache
RECRUITING
Las Vegas
New York
Roswell Park Cancer Institute
RECRUITING
Buffalo
Memorial Sloan Kettering Commack
RECRUITING
Commack
Northwell Health/Center for Advanced Medicine
SUSPENDED
Lake Success
North Shore University Hospital
SUSPENDED
Manhasset
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Mount Sinai Hospital
RECRUITING
New York
Rochester General Hospital
RECRUITING
Rochester
University of Rochester
RECRUITING
Rochester
State University of New York Upstate Medical University
RECRUITING
Syracuse
Montefiore Medical Center - Moses Campus
RECRUITING
The Bronx
Memorial Sloan Kettering Nassau
RECRUITING
Uniondale
Ohio
Case Western Reserve University
RECRUITING
Cleveland
Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Oregon
Providence Newberg Medical Center
RECRUITING
Newberg
Saint Alphonsus Cancer Care Center-Ontario
RECRUITING
Ontario
Providence Willamette Falls Medical Center
RECRUITING
Oregon City
Oregon Health and Science University
RECRUITING
Portland
Providence Portland Medical Center
RECRUITING
Portland
Providence Saint Vincent Medical Center
RECRUITING
Portland
Pennsylvania
Lehigh Valley Hospital-Cedar Crest
RECRUITING
Allentown
Geisinger Medical Center
RECRUITING
Danville
Penn State Milton S Hershey Medical Center
RECRUITING
Hershey
Lewistown Hospital
RECRUITING
Lewistown
Thomas Jefferson University Hospital
RECRUITING
Philadelphia
University of Pennsylvania/Abramson Cancer Center
RECRUITING
Philadelphia
University of Pittsburgh Cancer Institute (UPCI)
RECRUITING
Pittsburgh
Reading Hospital
RECRUITING
West Reading
Geisinger Wyoming Valley/Henry Cancer Center
RECRUITING
Wilkes-barre
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
South Carolina
Prisma Health Cancer Institute - Spartanburg
RECRUITING
Boiling Springs
Medical University of South Carolina
RECRUITING
Charleston
Prisma Health Cancer Institute - Easley
RECRUITING
Easley
Prisma Health Cancer Institute - Butternut
RECRUITING
Greenville
Prisma Health Cancer Institute - Eastside
RECRUITING
Greenville
Prisma Health Cancer Institute - Faris
RECRUITING
Greenville
Prisma Health Cancer Institute - Greer
RECRUITING
Greer
Prisma Health Cancer Institute - Seneca
RECRUITING
Seneca
South Dakota
Sanford Cancer Center Oncology Clinic
RECRUITING
Sioux Falls
Sanford USD Medical Center - Sioux Falls
RECRUITING
Sioux Falls
Tennessee
Baptist Memorial Hospital and Cancer Center-Collierville
RECRUITING
Collierville
University of Tennessee - Knoxville
RECRUITING
Knoxville
Baptist Memorial Hospital and Cancer Center-Memphis
RECRUITING
Memphis
Texas
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
RECRUITING
Houston
Ben Taub General Hospital
RECRUITING
Houston
Utah
George E Wahlen Department of Veterans Affairs Medical Center
RECRUITING
Salt Lake City
Huntsman Cancer Institute/University of Utah
RECRUITING
Salt Lake City
Virginia
University of Virginia Cancer Center
RECRUITING
Charlottesville
Inova Schar Cancer Institute
RECRUITING
Fairfax
Inova Fairfax Hospital
RECRUITING
Falls Church
VCU Massey Comprehensive Cancer Center
RECRUITING
Richmond
Vermont
University of Vermont and State Agricultural College
RECRUITING
Burlington
University of Vermont Medical Center
RECRUITING
Burlington
Washington
Swedish Cancer Institute-Edmonds
RECRUITING
Edmonds
Swedish Cancer Institute-Issaquah
RECRUITING
Issaquah
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Swedish Medical Center-First Hill
RECRUITING
Seattle
University of Washington Medical Center - Montlake
RECRUITING
Seattle
Wisconsin
ThedaCare Regional Cancer Center
RECRUITING
Appleton
Duluth Clinic Ashland
RECRUITING
Ashland
Aurora Cancer Care-Southern Lakes VLCC
RECRUITING
Burlington
Aurora Saint Luke's South Shore
RECRUITING
Cudahy
Marshfield Medical Center-EC Cancer Center
RECRUITING
Eau Claire
Aurora Health Care Germantown Health Center
RECRUITING
Germantown
Aurora Cancer Care-Grafton
RECRUITING
Grafton
Aurora BayCare Medical Center
RECRUITING
Green Bay
Saint Vincent Hospital Cancer Center at Saint Mary's
RECRUITING
Green Bay
Saint Vincent Hospital Cancer Center Green Bay
RECRUITING
Green Bay
Mercyhealth Hospital and Cancer Center - Janesville
RECRUITING
Janesville
Aurora Cancer Care-Kenosha South
RECRUITING
Kenosha
Gundersen Lutheran Medical Center
RECRUITING
La Crosse
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
RECRUITING
Madison
University of Wisconsin Carbone Cancer Center - University Hospital
RECRUITING
Madison
William S Middleton VA Medical Center
RECRUITING
Madison
Aurora Bay Area Medical Group-Marinette
RECRUITING
Marinette
Marshfield Medical Center-Marshfield
RECRUITING
Marshfield
Froedtert Menomonee Falls Hospital
RECRUITING
Menomonee Falls
Aurora Cancer Care-Milwaukee
RECRUITING
Milwaukee
Aurora Saint Luke's Medical Center
RECRUITING
Milwaukee
Aurora Sinai Medical Center
RECRUITING
Milwaukee
Medical College of Wisconsin
RECRUITING
Milwaukee
Marshfield Medical Center - Minocqua
RECRUITING
Minocqua
ProHealth D N Greenwald Center
RECRUITING
Mukwonago
Froedtert and MCW Moorland Reserve Health Center
RECRUITING
New Berlin
Drexel Town Square Health Center
RECRUITING
Oak Creek
ProHealth Oconomowoc Memorial Hospital
RECRUITING
Oconomowoc
Saint Vincent Hospital Cancer Center at Oconto Falls
RECRUITING
Oconto Falls
Vince Lombardi Cancer Clinic - Oshkosh
RECRUITING
Oshkosh
Aurora Cancer Care-Racine
RECRUITING
Racine
Marshfield Medical Center-Rice Lake
RECRUITING
Rice Lake
Saint Vincent Hospital Cancer Center at Sheboygan
RECRUITING
Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
RECRUITING
Sheboygan
Marshfield Medical Center-River Region at Stevens Point
RECRUITING
Stevens Point
Saint Vincent Hospital Cancer Center at Sturgeon Bay
RECRUITING
Sturgeon Bay
Aurora Medical Center in Summit
RECRUITING
Summit
Vince Lombardi Cancer Clinic-Two Rivers
RECRUITING
Two Rivers
ProHealth Waukesha Memorial Hospital
RECRUITING
Waukesha
UW Cancer Center at ProHealth Care
RECRUITING
Waukesha
Aurora Cancer Care-Milwaukee West
RECRUITING
Wauwatosa
Aurora West Allis Medical Center
RECRUITING
West Allis
Froedtert West Bend Hospital/Kraemer Cancer Center
RECRUITING
West Bend
Marshfield Medical Center - Weston
RECRUITING
Weston
Other Locations
Canada
Arthur J E Child Comprehensive Cancer Centre
RECRUITING
Calgary
University of Alberta Hospital
RECRUITING
Edmonton
CSSS Champlain-Charles Le Moyne
RECRUITING
Greenfield Park
QEII Health Sciences Centre/Nova Scotia Health Authority
RECRUITING
Halifax
Juravinski Cancer Centre at Hamilton Health Sciences
RECRUITING
Hamilton
CIUSSSEMTL-Hopital Maisonneuve-Rosemont
RECRUITING
Montreal
Jewish General Hospital
RECRUITING
Montreal
Odette Cancer Centre- Sunnybrook Health Sciences Centre
RECRUITING
Toronto
University Health Network-Princess Margaret Hospital
RECRUITING
Toronto
CancerCare Manitoba
RECRUITING
Winnipeg
Puerto Rico
Centro Comprensivo de Cancer de UPR
RECRUITING
San Juan
San Juan City Hospital
RECRUITING
San Juan
Time Frame
Start Date: 2024-06-18
Estimated Completion Date: 2029-05-15
Participants
Target number of participants: 2000
Treatments
Active_comparator: MM1MDS-A01 Regimen 1 (ASTX727)
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 Regimen 2. 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.
Experimental: MM1MDS-A01 Regimen 2 (ASTX727, enasidenib)
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.
Experimental: MM1MDS-CTG02 Arm 1 (Luspatercept)
Patients receive luspatercept SC on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration and blood sample collection throughout the study.
Experimental: MM1MDS-CTG02 Arm 2 (Luspatercept with epoetin alfa)
Patients receive luspatercept SC on day 1 and epoetin alfa SC QW for each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration and blood sample collection throughout the study.
Experimental: MM1MDS-CTG02 Arm 3 (Luspatercept and emavusertib)
Patients receive luspatercept SC on day 1 and emavusertib PO BID on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration and blood sample collection throughout the study.
Experimental: MM1OA-EA02 Regimen 1 (azacitidine, venetoclax)
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.
Experimental: MM1OA-EA02 Regimen 2 (azacitidine, venetoclax, gilteritinib)
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.
Experimental: MM1OA-EA02 Regimen 3 (azacitidine, venetoclax, gilteritinib)
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.
Active_comparator: MM1OA-MDS-A05 Cohort A, Arm 1 (ASTX727, venetoclax)
Patients receive ASTX727 PO QD on days 1-5 of each cycle and venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR, CRh, or CRi after cycle 4 continue treatment cycles every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow biopsy/aspiration and collection of blood samples throughout the trial.
Experimental: MM1OA-MDS-A05 Cohort A,Arm 2 (ASTX727,venetoclax,olutasidenib)
Patients receive ASTX727 PO QD on days 1-5 of each cycle, venetoclax PO QD on days 1-28 of each cycle, and olutasidenib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR, CRh, or CRi after cycle 4 continue treatment cycles every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow biopsy/aspiration and collection of blood samples throughout the trial.
Experimental: MM1OA-MDS-A05 Cohort B, Arm 3 (ASTX727, olutasidenib)
Patients receive ASTX727 PO QD on days 1-5 of each cycle and olutasidenib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR continue treatment cycles every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow biopsy/aspiration and collection of blood samples throughout the trial.
Active_comparator: MM1OA-MDS-A05 Cohort B, Arm 4 (ASTX727)
Patients receive ASTX727 PO QD on days 1-5 of each cycle. Cycles repeat every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients without CR after cycle 6 may then cross-over to Arm 3. Patients with CR, as well as patients without CR but deriving clinical benefit after cycle 6 continue treatment cycles every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow biopsy/aspiration and collection of blood samples throughout the trial.
Experimental: MM1OA-MDS-A05 Cohort C (olutasidenib)
Patients receive olutasidenib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients deriving clinical benefit after cycle 6 continue treatment cycles every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow biopsy/aspiration and collection of blood samples throughout the trial.
Active_comparator: MM1OA-S03 Arm 1 (ASTX727, venetoclax)
Patients receive ASTX727 PO QD on days 1-5 and venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial.
Experimental: MM1OA-S03 Arm 2 (ASTX727, venetoclax, enasidenib)
Patients receive ASTX727 PO QD on days 1-5, venetoclax PO QD on days 1-28, 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 undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial.
Active_comparator: MM1OA-S04 Arm 1 (ASTX727 with standard duration venetoclax)
Patients receive ASTX727 PO QD on days 1-5 and venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration and blood sample collection throughout the study.
Experimental: MM1OA-S04 Arm 2 (ASTX727 with shorter duration venetoclax)
Patients receive ASTX727 PO QD on days 1-5 and venetoclax PO QD on days 1-14 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration and blood sample collection throughout the study.
Active_comparator: MM1YA-A04 Regimen 1 (gemtuzumab ozogamicin, chemotherapy)
Patients receive gemtuzumab ozogamicin IV on days 1 and 4, cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients may also undergo optional buccal swab collection throughout the study.
Experimental: MM1YA-A04 Regimen 2 (venetoclax, chemotherapy)
Patients receive gemtuzumab ozogamicin IV on days 1 and 4, cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients may also undergo optional buccal swab collection throughout the study.
Experimental: MM1YA-CTG01 Arm I (daunorubicin, cytarabine, venetoclax)
Patients receive daunorubicin IV on days 2-4, cytarabine IV continuously on days 2-8, and venetoclax PO QD on days 1-11. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Based on a bone marrow aspiration assessment (completed at the discretion of the treating investigator), patients may receive reinduction consisting of daunorubicin IV on days 2-3, cytarabine IV continuously on days 2-6, and venetoclax PO QD on days 1-8. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.
Experimental: MM1YA-CTG01 Arm II (azacitidine, venetoclax)
Patients receive azacitidine IV or SC on days 1-7 or days 1-5 and 8-9 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for a total of 2 cycles, in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.
Active_comparator: MM1YA-CTG01 Arm III (daunorubicin, cytarabine)
Patients receive daunorubicin IV on days 1-3 and cytarabine IV, continuously, on days 1-7. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Based on a bone marrow aspiration assessment (completed at the discretion of the treating investigator), patients may receive reinduction consisting of cytarabine IV, continuously, on days 1-5 and daunorubicin IV on days 1-2. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.
Active_comparator: MM1YA-S01 Arm I (cytarabine, daunorubicin)
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.
Experimental: MM1YA-S01 Arm II (cytarabine, daunorubicin, venetoclax)
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.
Experimental: MM1YA-S01 Arm III (azacitidine, venetoclax)
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.
Experimental: MM1YA-S01 Arm IV (Vyxeos)
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.
Experimental: MM1YA-S01 Arm V (Vyxeos, venetoclax)
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.
Active_comparator: MM2YA-EA01 Arm A (cytarabine)
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.
Experimental: MM2YA-EA01 Arm B (cytarabine, venetoclax)
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.
Experimental: MM2YA-EA01 Arm C (Vyxeos, venetoclax)
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.
Experimental: MM2YA-EA01 Arm D (azacitidine, venetoclax)
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.
Experimental: MM3TCT-A03 Conditioning 1A (matched donors with venetoclax)
Patients receive venetoclax PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
Placebo_comparator: MM3TCT-A03 Conditioning 1B (matched donors with placebo)
Patients receive placebo PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
Experimental: MM3TCT-A03 Conditioning 2A (haplo/mismatch with venetoclax)
Patients receive venetoclax PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
Placebo_comparator: MM3TCT-A03 Conditioning 2B (haplo/mismatch with placebo)
Patients receive placebo PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
Experimental: MM3TCT-A03 Maintenance I (venetoclax)
Patients receive venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 1 year post transplant (9 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
Placebo_comparator: MM3TCT-A03 Maintenance II (placebo)
Patients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 1 year post transplant (9 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
Experimental: Screening (mutation carrier screening)
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.
Experimental: TAP (SOC treatment, mutation carrier screening)
Patients continue SOC treatment and undergo continued bone marrow aspiration and blood collection for possible future substudy assignment.
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov