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Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)

RecruitingPhase 2

A Randomized Phase II Study Comparing Cytarabine + Daunorubicin (7 + 3) vs (Daunorubicin and Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, Azacitidine + Venetoclax, and (Daunorubicin and Cytarabine) Liposome + Venetoclax in Patients Aged 59 or Younger Who Are Considered High-Risk (Adverse) Acute Myeloid Leukemia As Determined by MYELOMATCH; A MYELOMATCH SubStudy

Who can join

Ages 18 to 59 · All sexes

Full eligibility criteria
Inclusion Criteria:

* STEP 1 REGISTRATION:
* Participants must have been registered to Master Screening and Re-Assessment Protocol, MYELOMATCH, prior to consenting to this study. Participants must have been assigned to this clinical trial, via MATCHBox, prior to registration to this study.

  * Note: Pre-enrollment/diagnosis labs must have already been performed under MYELOMATCH
* Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) per World Health Organization (WHO) criteria
* Participants must have high-risk (adverse) AML per European LeukemiaNet (ELN) 2017 criteria
* Participants with therapy-related AML (t-AML), or with AML evolving from an antecedent hematologic disorder (such as myeloproliferative neoplasm), or AML with myelodysplasia-related changes (AML-MRC) are eligible-unless they were previously treated
* Acute promyelocytic leukemia is excluded
* Participants with favorable or intermediate risk disease per ELN 2017 criteria are excluded
* Participants with FLT3 mutations (ITD or TKD) are excluded
* Participants with t(9;22) translocation are excluded
* A single dose of intrathecal chemotherapy for AML is allowed prior to study entry
* Prior anthracycline therapy for any indication is allowed but must not exceed a cumulative lifetime dose of 200 mg/m\^2 daunorubicin or equivalent
* Participants must not have received or be currently receiving any prior therapy for acute myeloid leukemia. Hydroxyurea to control the white blood cells (WBC) is allowed prior to registration and initiation of protocol-defined therapy. All trans retinoic acid (ATRA) given until a diagnosis of acute promyelocytic leukemia is ruled out is also allowed. For urgent cytoreduction, cytarabine may be given either as a single dose or in multiple doses not to exceed 2500 mg
* Participants must not be receiving or planning to receive any other investigational agents before completing protocol therapy
* Participants must be between 18 and 59 years of age
* Participants must have Zubrod performance status =\< 3 as determined by a complete medical history and physical exam (H\&P) completed within 7 days prior to registration
* Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications
* Participants with a known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at time of registration and have undetectable HIV viral load on the most recent test results obtained within 6 months prior to registration
* Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load within 28 days prior to registration and be on suppressive therapy, if indicated
* Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with active HCV infection who are currently on treatment must have an undetectable HCV viral load within 28 days prior to registration
* The following tests must be performed within 14 days prior to registration to establish baseline values:

  * Complete blood count (CBC)/differential/platelets
  * Total bilirubin
  * Lactate dehydrogenase (LDH)
  * Albumin
  * Glucose
  * Fibrinogen
* Participants must have adequate kidney function as evidenced by creatinine clearance \>= 30mL/min (by Cockcroft Gault) within 7 days prior to registration
* Participants must have adequate liver function as evidenced by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x upper limit of normal (ULN) within 7 days prior to registration- unless elevations are considered due to leukemia in the opinion of the treating investigator
* Total bilirubin =\< 2.0 x ULN (or 5.0 x ULN if the participant has a history of Gilbert's disease) within 28 days prior to registration
* Participants must have adequate cardiac function as determined by echocardiography or MUGA scan with an ejection fraction \>= 50% within 28 days prior to registration
* Participants with a prior or concurrent malignancy whose natural history (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. No concurrent therapies for such malignancy are allowed with the exception of hormonal therapy
* Participants with central nervous system (CNS) disease are eligible for this trial and will be treated according to institutional guidelines with intrathecal chemotherapy for this aspect of their disease.
* Participants with known history of Wilson's disease or other known copper-metabolism disorder are excluded
* Participants must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use 2 contraception methods. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods (e.g., hormonal contraceptives \[examples include birth control pills, vaginal rings, or patches\] associated with inhibition of ovulation for at least 1 month prior to taking study drug), "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures. A barrier method should be used during this study along with hormonal contraceptives from initial study drug administration to 30 days after the last dose of study drug as drug-drug interaction with venetoclax is unknown
* Participants must have agreed to have specimens submitted for translational medicine (MRD) under MYELOMATCH and specimens must be submitted
* Participants must be offered the opportunity to participate in specimen banking

  * Note: Specimens must be collected and submitted using the Southwest Oncology Group (SWOG) Specimen Tracking System
* 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

  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
* 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

About the study

This phase II MyeloMATCH treatment trial tests whether the standard approach of cytarabine and daunorubicin in comparison to the following experimental regimens works to shrink cancer in patients with high risk acute myeloid leukemia (AML): 1) daunorubicin and cytarabine liposome alone; 2) cytarabine and daunorubicin with venetoclax; 3) azacitidine and venetoclax; 4) daunorubicin and cytarabine liposome and venetoclax. "High-risk" refers to traits that have been known to make the AML harder to treat. Cytarabine is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in the body. Daunorubicin is in a class of medications called anthracyclines. It also works by slowing or stopping the growth of cancer cells in the body. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells. 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. There is evidence that these newer experimental treatment regimens may work better in getting rid of more AML compared to the standard approach of cytarabine and daunorubicin.

What is being tested

Sponsor: National Cancer Institute (NCI) · Participants: 335 · Started: Sep 25, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT05554406

Locations in the U.S.

AlabamaUniversity of Alabama at Birmingham Cancer Center, Birmingham
ArizonaMayo Clinic Hospital in Arizona, Phoenix
Banner University Medical Center - Tucson, Tucson
University of Arizona Cancer Center-North Campus, Tucson
ArkansasUniversity of Arkansas for Medical Sciences, Little Rock
CaliforniaCedars-Sinai Medical Center, Los Angeles
Kaiser Permanente-Oakland, Oakland
Kaiser Permanente-Roseville, Roseville
University of California Davis Comprehensive Cancer Center, Sacramento
UCSF Medical Center-Parnassus, San Francisco
Kaiser Permanente Medical Center - Santa Clara, Santa Clara
ConnecticutYale University, New Haven
FloridaMayo Clinic in Florida, Jacksonville
Miami Cancer Institute, Miami
Memorial Hospital West, Pembroke Pines
GeorgiaPhoebe Putney Memorial Hospital, Albany
Augusta University Medical Center, Augusta
HawaiiHawaii Cancer Care Inc - Waterfront Plaza, Honolulu
Kapiolani Medical Center for Women and Children, Honolulu
Straub Clinic and Hospital, Honolulu
Hawaii Cancer Care - Westridge, ‘Aiea
Pali Momi Medical Center, ‘Aiea
IdahoSaint Alphonsus Cancer Care Center-Boise, Boise
Saint Luke's Cancer Institute - Boise, Boise
Saint Alphonsus Cancer Care Center-Caldwell, Caldwell
Kootenai Health - Coeur d'Alene, Coeur d'Alene
Saint Luke's Cancer Institute - Fruitland, Fruitland
Saint Luke's Cancer Institute - Meridian, Meridian
Saint Alphonsus Cancer Care Center-Nampa, Nampa
Saint Luke's Cancer Institute - Nampa, Nampa
Kootenai Clinic Cancer Services - Post Falls, Post Falls
Kootenai Clinic Cancer Services - Sandpoint, Sandpoint
IllinoisIllinois CancerCare-Bloomington, Bloomington
OSF Saint Joseph Medical Center, Bloomington
Illinois CancerCare-Canton, Canton
Illinois CancerCare-Carthage, Carthage
Northwestern University, Chicago
University of Chicago Comprehensive Cancer Center, Chicago
Cancer Care Specialists of Illinois - Decatur, Decatur
Decatur Memorial Hospital, Decatur
Illinois CancerCare-Dixon, Dixon
Crossroads Cancer Center, Effingham
Illinois CancerCare-Eureka, Eureka
NorthShore University HealthSystem-Evanston Hospital, Evanston
Illinois CancerCare-Galesburg, Galesburg
NorthShore University HealthSystem-Glenbrook Hospital, Glenview
NorthShore University HealthSystem-Highland Park Hospital, Highland Park
Illinois CancerCare-Kewanee Clinic, Kewanee
Illinois CancerCare-Macomb, Macomb
Loyola University Medical Center, Maywood
UC Comprehensive Cancer Center at Silver Cross, New Lenox
Cancer Care Center of O'Fallon, O'Fallon
University of Chicago Medicine-Orland Park, Orland Park
Illinois CancerCare-Ottawa Clinic, Ottawa
Illinois CancerCare-Pekin, Pekin
Illinois CancerCare-Peoria, Peoria
Methodist Medical Center of Illinois, Peoria
OSF Saint Francis Medical Center, Peoria
Illinois CancerCare-Peru, Peru
Illinois CancerCare-Princeton, Princeton
Southern Illinois University School of Medicine, Springfield
Springfield Clinic, Springfield
Springfield Memorial Hospital, Springfield
Illinois CancerCare - Washington, Washington
IndianaUChicago Medicine Northwest Indiana, Crown Point
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis
IowaUniversity of Iowa/Holden Comprehensive Cancer Center, Iowa City
KansasUniversity of Kansas Clinical Research Center, Fairway
University of Kansas Cancer Center, Kansas City
University of Kansas Hospital-Indian Creek Campus, Overland Park
University of Kansas Hospital-Westwood Cancer Center, Westwood
KentuckyUniversity of Kentucky/Markey Cancer Center, Lexington
The James Graham Brown Cancer Center at University of Louisville, Louisville
UofL Health Medical Center Northeast, Louisville
LouisianaLSU Health Baton Rouge-North Clinic, Baton Rouge
Our Lady of The Lake, Baton Rouge
Our Lady of the Lake Physician Group, Baton Rouge
MaineMaineHealth Maine Medical Center - Portland, Portland
MaineHealth Maine Medical Center- Scarborough, Scarborough
MaineHealth Cancer Care and IV Therapy - South Portland, South Portland
MarylandJohns Hopkins University/Sidney Kimmel Cancer Center, Baltimore
Walter Reed National Military Medical Center, Bethesda
MassachusettsBeth Israel Deaconess Medical Center, Boston
Dana-Farber Cancer Institute, Boston
Tufts Medical Center, Boston
Lahey Clinic, Burlington
Lahey Clinic Peabody, Peabody
MichiganTrinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor
Trinity Health IHA Medical Group Hematology Oncology - Brighton, Brighton
Trinity Health IHA Medical Group Hematology Oncology - Canton, Canton
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea
Wayne State University/Karmanos Cancer Institute, Detroit
Weisberg Cancer Treatment Center, Farmington Hills
Cancer Hematology Centers - Flint, Flint
Genesys Hurley Cancer Institute, Flint
Hurley Medical Center, Flint
Trinity Health Saint Mary Mercy Livonia Hospital, Livonia
Trinity Health Saint Joseph Mercy Oakland Hospital, Pontiac
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus, Ypsilanti
MinnesotaMercy Hospital, Coon Rapids
Essentia Health - Deer River Clinic, Deer River
Essentia Health Cancer Center, Duluth
Fairview Southdale Hospital, Edina
Essentia Health Hibbing Clinic, Hibbing
Abbott-Northwestern Hospital, Minneapolis
Mayo Clinic in Rochester, Rochester
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park
Regions Hospital, Saint Paul
United Hospital, Saint Paul
Essentia Health Sandstone, Sandstone
Essentia Health Virginia Clinic, Virginia
MississippiBaptist Memorial Hospital and Cancer Center-Golden Triangle, Columbus
Baptist Cancer Center-Grenada, Grenada
Baptist Memorial Hospital and Cancer Center-Union County, New Albany
Baptist Memorial Hospital and Cancer Center-Oxford, Oxford
Baptist Memorial Hospital and Cancer Center-Desoto, Southhaven
MissouriSiteman Cancer Center at Saint Peters Hospital, City of Saint Peters
Siteman Cancer Center at West County Hospital, Creve Coeur
Siteman Cancer Center at Christian Hospital, St Louis
Siteman Cancer Center-South County, St Louis
Washington University School of Medicine, St Louis
MontanaCommunity Hospital of Anaconda, Anaconda
Billings Clinic Cancer Center, Billings
Bozeman Health Deaconess Hospital, Bozeman
Benefis Sletten Cancer Institute, Great Falls
Logan Health Medical Center, Kalispell
Community Medical Center, Missoula
NebraskaNebraska Medicine-Bellevue, Bellevue
Nebraska Medicine-Village Pointe, Omaha
University of Nebraska Medical Center, Omaha
NevadaOptumCare Cancer Care at Charleston, Las Vegas
OptumCare Cancer Care at Fort Apache, Las Vegas
New JerseyMemorial Sloan Kettering Basking Ridge, Basking Ridge
Cooper Hospital University Medical Center, Camden
Cooperman Barnabas Medical Center, Livingston
Monmouth Medical Center, Long Branch
Memorial Sloan Kettering Monmouth, Middletown
Memorial Sloan Kettering Bergen, Montvale
Rutgers Cancer Institute of New Jersey, New Brunswick
The Valley Hospital - Luckow Pavilion, Paramus
Valley Health System Ridgewood Campus, Ridgewood
Community Medical Center, Toms River
New MexicoUniversity of New Mexico Cancer Center, Albuquerque
New YorkRoswell Park Cancer Institute, Buffalo
Memorial Sloan Kettering Commack, Commack
Memorial Sloan Kettering Westchester, Harrison
Northwell Health/Center for Advanced Medicine, Lake Success
North Shore University Hospital, Manhasset
Memorial Sloan Kettering Cancer Center, New York
Mount Sinai Hospital, New York
University of Rochester, Rochester
Stony Brook University Medical Center, Stony Brook
State University of New York Upstate Medical University, Syracuse
Montefiore Medical Center - Moses Campus, The Bronx
Memorial Sloan Kettering Nassau, Uniondale
North CarolinaCarolinas Medical Center/Levine Cancer Institute, Charlotte
Duke University Medical Center, Durham
East Carolina University, Greenville
Wake Forest University Health Sciences, Winston-Salem
OhioCase Western Reserve University, Cleveland
Ohio State University Comprehensive Cancer Center, Columbus
OklahomaUniversity of Oklahoma Health Sciences Center, Oklahoma City
OregonSaint Alphonsus Cancer Care Center-Ontario, Ontario
Providence Portland Medical Center, Portland
Providence Saint Vincent Medical Center, Portland
PennsylvaniaLehigh Valley Hospital-Cedar Crest, Allentown
Geisinger Medical Center, Danville
Penn State Milton S Hershey Medical Center, Hershey
Lewistown Hospital, Lewistown
Thomas Jefferson University Hospital, Philadelphia
University of Pennsylvania/Abramson Cancer Center, Philadelphia
UPMC Hillman Cancer Center, Pittsburgh
Reading Hospital, West Reading
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre
Rhode IslandRhode Island Hospital, Providence
South CarolinaPrisma Health Cancer Institute - Spartanburg, Boiling Springs
Medical University of South Carolina, Charleston
Prisma Health Cancer Institute - Easley, Easley
Prisma Health Cancer Institute - Butternut, Greenville
Prisma Health Cancer Institute - Eastside, Greenville
Prisma Health Cancer Institute - Faris, Greenville
Prisma Health Cancer Institute - Greer, Greer
Prisma Health Cancer Institute - Seneca, Seneca
TennesseeBaptist Memorial Hospital and Cancer Center-Collierville, Collierville
Baptist Memorial Hospital and Cancer Center-Memphis, Memphis
UtahHuntsman Cancer Institute/University of Utah, Salt Lake City
VermontUniversity of Vermont Medical Center, Burlington
University of Vermont and State Agricultural College, Burlington
VirginiaUniversity of Virginia Cancer Center, Charlottesville
Inova Schar Cancer Institute, Fairfax
Inova Fairfax Hospital, Falls Church
WashingtonSwedish Cancer Institute-Edmonds, Edmonds
Swedish Cancer Institute-Issaquah, Issaquah
Swedish Medical Center-First Hill, Seattle
WisconsinThedaCare Regional Cancer Center, Appleton
ThedaCare Regional Medical Center - Appleton, Appleton
Duluth Clinic Ashland, Ashland
Saint Vincent Hospital Cancer Center Green Bay, Green Bay
Saint Vincent Hospital Cancer Center at Saint Mary's, Green Bay
Gundersen Lutheran Medical Center, La Crosse
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center, Madison
University of Wisconsin Carbone Cancer Center - University Hospital, Madison
Medical College of Wisconsin, Milwaukee
Marshfield Medical Center-River Region at Stevens Point, Stevens Point
Marshfield Medical Center - Weston, Weston

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.