Home › Acute Myeloid Leukemia › NCT05554406
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
- Azacitidine (drug)
- Biospecimen Collection (procedure)
- Bone Marrow Aspiration (procedure)
- Cytarabine (drug)
- Daunorubicin Hydrochloride (drug)
- Echocardiography Test (procedure)
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.
| Alabama | University of Alabama at Birmingham Cancer Center, Birmingham |
| Arizona | Mayo Clinic Hospital in Arizona, Phoenix Banner University Medical Center - Tucson, Tucson University of Arizona Cancer Center-North Campus, Tucson |
| Arkansas | University of Arkansas for Medical Sciences, Little Rock |
| California | Cedars-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 |
| Connecticut | Yale University, New Haven |
| Florida | Mayo Clinic in Florida, Jacksonville Miami Cancer Institute, Miami Memorial Hospital West, Pembroke Pines |
| Georgia | Phoebe Putney Memorial Hospital, Albany Augusta University Medical Center, Augusta |
| Hawaii | Hawaii 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 |
| Idaho | Saint 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 |
| Illinois | Illinois 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 |
| Indiana | UChicago Medicine Northwest Indiana, Crown Point Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis |
| Iowa | University of Iowa/Holden Comprehensive Cancer Center, Iowa City |
| Kansas | University 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 |
| Kentucky | University of Kentucky/Markey Cancer Center, Lexington The James Graham Brown Cancer Center at University of Louisville, Louisville UofL Health Medical Center Northeast, Louisville |
| Louisiana | LSU Health Baton Rouge-North Clinic, Baton Rouge Our Lady of The Lake, Baton Rouge Our Lady of the Lake Physician Group, Baton Rouge |
| Maine | MaineHealth Maine Medical Center - Portland, Portland MaineHealth Maine Medical Center- Scarborough, Scarborough MaineHealth Cancer Care and IV Therapy - South Portland, South Portland |
| Maryland | Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore Walter Reed National Military Medical Center, Bethesda |
| Massachusetts | Beth Israel Deaconess Medical Center, Boston Dana-Farber Cancer Institute, Boston Tufts Medical Center, Boston Lahey Clinic, Burlington Lahey Clinic Peabody, Peabody |
| Michigan | Trinity 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 |
| Minnesota | Mercy 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 |
| Mississippi | Baptist 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 |
| Missouri | Siteman 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 |
| Montana | Community 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 |
| Nebraska | Nebraska Medicine-Bellevue, Bellevue Nebraska Medicine-Village Pointe, Omaha University of Nebraska Medical Center, Omaha |
| Nevada | OptumCare Cancer Care at Charleston, Las Vegas OptumCare Cancer Care at Fort Apache, Las Vegas |
| New Jersey | Memorial 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 Mexico | University of New Mexico Cancer Center, Albuquerque |
| New York | Roswell 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 Carolina | Carolinas Medical Center/Levine Cancer Institute, Charlotte Duke University Medical Center, Durham East Carolina University, Greenville Wake Forest University Health Sciences, Winston-Salem |
| Ohio | Case Western Reserve University, Cleveland Ohio State University Comprehensive Cancer Center, Columbus |
| Oklahoma | University of Oklahoma Health Sciences Center, Oklahoma City |
| Oregon | Saint Alphonsus Cancer Care Center-Ontario, Ontario Providence Portland Medical Center, Portland Providence Saint Vincent Medical Center, Portland |
| Pennsylvania | Lehigh 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 Island | Rhode Island Hospital, Providence |
| South Carolina | Prisma 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 |
| Tennessee | Baptist Memorial Hospital and Cancer Center-Collierville, Collierville Baptist Memorial Hospital and Cancer Center-Memphis, Memphis |
| Utah | Huntsman Cancer Institute/University of Utah, Salt Lake City |
| Vermont | University of Vermont Medical Center, Burlington University of Vermont and State Agricultural College, Burlington |
| Virginia | University of Virginia Cancer Center, Charlottesville Inova Schar Cancer Institute, Fairfax Inova Fairfax Hospital, Falls Church |
| Washington | Swedish Cancer Institute-Edmonds, Edmonds Swedish Cancer Institute-Issaquah, Issaquah Swedish Medical Center-First Hill, Seattle |
| Wisconsin | ThedaCare 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.