Taking people in United StatesPhase 2

Testing Venetoclax Plus Azacitidine With or Without Gilteritinib for FLT3 Leukemia

Tests adding gilteritinib to venetoclax and azacitidine in older adults with FLT3-mutated leukemia.

Plain-language title generated from the registry record
Registry title: Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)

Key facts

Where: ‘Aiea, Albany, Albuquerque, Allentown, Anaconda, Appleton, Ashland, Augusta, Basking Ridge, Baton Rouge, Berkeley, Bethesda, Billings, Birmingham, Boiling Springs, Boise, Boston, Bozeman, Brighton, Brunswick, Buffalo, Burlington, Caldwell, Canton, Chapel Hill, Charleston, Charlotte, Charlottesville, Chelsea, Chicago, City of Saint Peters, Cleveland, Clinton Township, Coeur d'Alene, Collierville, Columbus, Commack, Coon Rapids, Creve Coeur, Crown Point, Danville, Decatur, Deer River, DeKalb, Detroit, Dublin, Duluth, Durham, Easley, Edina, Edmonds, Effingham, Evanston, Fairway, Flint, Fremont, Fresno, Fruitland, Gainesville, Geneva, Glenview, Grayslake, Great Falls, Green Bay, Greenville, Greer, Grenada, Hershey, Hibbing, Highland Park, Hines, Honolulu, Houston, Indianapolis, Iowa City, Issaquah, Jackson, Kalispell, Kansas City, Knoxville, La Crosse, Lake Forest, Lake Success, Las Vegas, Lebanon, Lexington, Little Rock, Livingston, Livonia, Long Branch, Los Angeles, Louisville, Madison, Manhasset, Mattoon, Maywood, Memphis, Meridian, Miami, Middletown, Milwaukee, Minneapolis, Missoula, Modesto, Montvale, Nampa, New Albany, New Brunswick, New Haven, New Lenox, New York, Newberg, Novi, O'Fallon, Oakland, Oconto Falls, Oklahoma City, Ontario, Oregon City, Orland Park, Overland Park, Oxford, Paramus, Peabody, Philadelphia, Pittsburgh, Pontiac, Portland, Post Falls, Providence, Richmond, Ridgewood, Rochester, Roseville, Sacramento, Saint Louis Park, Saint Paul, Salt Lake City, San Francisco, San Jose, San Leandro, San Mateo, San Rafael, Sandpoint, Sandstone, Santa Clara, Santa Rosa, Scarborough, Seattle, Seneca, Sheboygan, Shiloh, South Portland, South San Francisco, Southhaven, Springfield, St Louis, Stevens Point, Stony Brook, Sturgeon Bay, Syracuse, Toms River, Topeka, Tucson, Urbana, Vallejo, Virginia, Walnut Creek, Warrenville, West Bloomfield, West Haven, West Reading, Weston, Westwood, Wilkes-Barre, Winston-Salem, and Ypsilanti, United StatesSee the 226 sites
Phase: Phase 2

Where in United States

Hawaii Cancer Care - Westridge‘Aiea, United StatesTaking people
Pali Momi Medical Center‘Aiea, United StatesTaking people
Phoebe Putney Memorial HospitalAlbany, United StatesTaking people
University of New Mexico Cancer CenterAlbuquerque, United StatesTaking people
Lehigh Valley Hospital-Cedar CrestAllentown, United StatesTaking people
Community Hospital of AnacondaAnaconda, United StatesTaking people
ThedaCare Regional Cancer CenterAppleton, United StatesTaking people
Duluth Clinic AshlandAshland, United StatesTaking people
Augusta University Medical CenterAugusta, United StatesNo longer taking part
Memorial Sloan Kettering Basking RidgeBasking Ridge, United StatesTaking people
LSU Health Baton Rouge-North ClinicBaton Rouge, United StatesTaking people
Our Lady of The LakeBaton Rouge, United StatesTaking people
Our Lady of the Lake Physician GroupBaton Rouge, United StatesTaking people
Alta Bates Summit Medical Center-Herrick CampusBerkeley, United StatesNo longer taking part
Walter Reed National Military Medical CenterBethesda, United StatesTaking people
Billings Clinic Cancer CenterBillings, United StatesTaking people
University of Alabama at Birmingham Cancer CenterBirmingham, United StatesTaking people
Prisma Health Cancer Institute - SpartanburgBoiling Springs, United StatesTaking people
Saint Alphonsus Cancer Care Center-BoiseBoise, United StatesTaking people
Saint Luke's Cancer Institute - BoiseBoise, United StatesTaking people
Beth Israel Deaconess Medical CenterBoston, United StatesTaking people
Dana-Farber Cancer InstituteBoston, United StatesTaking people
Tufts Medical CenterBoston, United StatesTaking people
Bozeman Health Deaconess HospitalBozeman, United StatesTaking people
Trinity Health IHA Medical Group Hematology Oncology - BrightonBrighton, United StatesTaking people
MaineHealth Cancer Care and IV Therapy - BrunswickBrunswick, United StatesTaking people
Mid Coast HospitalBrunswick, United StatesTaking people
Roswell Park Cancer InstituteBuffalo, United StatesTaking people
Lahey ClinicBurlington, United StatesTaking people
University of Vermont and State Agricultural CollegeBurlington, United StatesTaking people
University of Vermont Medical CenterBurlington, United StatesTaking people
Saint Alphonsus Cancer Care Center-CaldwellCaldwell, United StatesTaking people
Trinity Health IHA Medical Group Hematology Oncology - CantonCanton, United StatesTaking people
UNC Lineberger Comprehensive Cancer CenterChapel Hill, United StatesNo longer taking part
Medical University of South CarolinaCharleston, United StatesTaking people
Carolinas Medical Center/Levine Cancer InstituteCharlotte, United StatesTaking people
University of Virginia Cancer CenterCharlottesville, United StatesTaking people
Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalChelsea, United StatesTaking people
Northwestern UniversityChicago, United StatesTaking people
University of Chicago Comprehensive Cancer CenterChicago, United StatesTaking people
University of IllinoisChicago, United StatesTaking people
Siteman Cancer Center at Saint Peters HospitalCity of Saint Peters, United StatesTaking people
Case Western Reserve UniversityCleveland, United StatesTaking people
Henry Ford Macomb Hospital-Clinton TownshipClinton Township, United StatesNo longer taking part
Kootenai Health - Coeur d'AleneCoeur d'Alene, United StatesTaking people
Baptist Memorial Hospital and Cancer Center-ColliervilleCollierville, United StatesTaking people
Baptist Memorial Hospital and Cancer Center-Golden TriangleColumbus, United StatesTaking people
Ohio State University Comprehensive Cancer CenterColumbus, United StatesTaking people
Memorial Sloan Kettering CommackCommack, United StatesTaking people
Mercy HospitalCoon Rapids, United StatesTaking people
Siteman Cancer Center at West County HospitalCreve Coeur, United StatesTaking people
UChicago Medicine Northwest IndianaCrown Point, United StatesTaking people
Carle at The RiverfrontDanville, United StatesTaking people
Geisinger Medical CenterDanville, United StatesTaking people
Cancer Care Specialists of Illinois - DecaturDecatur, United StatesTaking people
Decatur Memorial HospitalDecatur, United StatesTaking people
Essentia Health - Deer River ClinicDeer River, United StatesTaking people
Northwestern Medicine Cancer Center KishwaukeeDeKalb, United StatesTaking people
Henry Ford HospitalDetroit, United StatesNo longer taking part
Kaiser Permanente DublinDublin, United StatesTaking people
Essentia Health Cancer CenterDuluth, United StatesTaking people
Duke University Medical CenterDurham, United StatesTaking people
Prisma Health Cancer Institute - EasleyEasley, United StatesTaking people
Fairview Southdale HospitalEdina, United StatesTaking people
Minnesota Oncology - EdinaEdina, United StatesTaking people
Swedish Cancer Institute-EdmondsEdmonds, United StatesTaking people
Carle Physician Group-EffinghamEffingham, United StatesTaking people
Crossroads Cancer CenterEffingham, United StatesTaking people
NorthShore University HealthSystem-Evanston HospitalEvanston, United StatesTaking people
University of Kansas Clinical Research CenterFairway, United StatesTaking people
Cancer Hematology Centers - FlintFlint, United StatesTaking people
Genesys Hurley Cancer InstituteFlint, United StatesTaking people
Hurley Medical CenterFlint, United StatesTaking people
Genesee Hematology Oncology PCFlint, United StatesNo longer taking part
Kaiser Permanente-FremontFremont, United StatesTaking people
Kaiser Permanente Fresno Orchard PlazaFresno, United StatesTaking people
Kaiser Permanente-FresnoFresno, United StatesNo longer taking part
Saint Luke's Cancer Institute - FruitlandFruitland, United StatesTaking people
UF Health Cancer Institute - GainesvilleGainesville, United StatesTaking people
Northwestern Medicine Cancer Center DelnorGeneva, United StatesTaking people
NorthShore University HealthSystem-Glenbrook HospitalGlenview, United StatesTaking people
Northwestern Medicine Glenview Outpatient CenterGlenview, United StatesTaking people
Northwestern Medicine Grayslake Outpatient CenterGrayslake, United StatesTaking people
Benefis Sletten Cancer InstituteGreat Falls, United StatesTaking people
Saint Vincent Hospital Cancer Center at Saint Mary'sGreen Bay, United StatesTaking people
Saint Vincent Hospital Cancer Center Green BayGreen Bay, United StatesTaking people
East Carolina UniversityGreenville, United StatesTaking people
Prisma Health Cancer Institute - ButternutGreenville, United StatesTaking people
Prisma Health Cancer Institute - EastsideGreenville, United StatesTaking people
Prisma Health Cancer Institute - FarisGreenville, United StatesTaking people
Prisma Health Cancer Institute - GreerGreer, United StatesTaking people
Baptist Cancer Center-GrenadaGrenada, United StatesTaking people
Penn State Milton S. Hershey Medical CenterHershey, United StatesTaking people
Essentia Health Hibbing ClinicHibbing, United StatesTaking people
NorthShore University HealthSystem-Highland Park HospitalHighland Park, United StatesTaking people
Edward Hines Jr VA HospitalHines, United StatesTaking people
Hawaii Cancer Care Inc - Waterfront PlazaHonolulu, United StatesTaking people
Kaiser Permanente Moanalua Medical CenterHonolulu, United StatesTaking people
Straub Clinic and HospitalHonolulu, United StatesTaking people
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterHouston, United StatesTaking people
Ben Taub General HospitalHouston, United StatesTaking people
Indiana University/Melvin and Bren Simon Cancer CenterIndianapolis, United StatesTaking people
University of Iowa/Holden Comprehensive Cancer CenterIowa City, United StatesTaking people
Swedish Cancer Institute-IssaquahIssaquah, United StatesTaking people
Allegiance HealthJackson, United StatesNo longer taking part
Logan Health Medical CenterKalispell, United StatesTaking people
University of Kansas Cancer CenterKansas City, United StatesTaking people
University of Tennessee - KnoxvilleKnoxville, United StatesNo longer taking part
Gundersen Lutheran Medical CenterLa Crosse, United StatesTaking people
Northwestern Medicine Lake Forest HospitalLake Forest, United StatesTaking people
Northwell Health/Center for Advanced MedicineLake Success, United StatesTaking people
OptumCare Cancer Care at CharlestonLas Vegas, United StatesNo longer taking part
OptumCare Cancer Care at Fort ApacheLas Vegas, United StatesNo longer taking part
Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanon, United StatesTaking people
University of Kentucky/Markey Cancer CenterLexington, United StatesTaking people
University of Arkansas for Medical SciencesLittle Rock, United StatesTaking people
Cooperman Barnabas Medical CenterLivingston, United StatesTaking people
Trinity Health Saint Mary Mercy Livonia HospitalLivonia, United StatesTaking people
Monmouth Medical CenterLong Branch, United StatesTaking people
Cedars-Sinai Medical CenterLos Angeles, United StatesTaking people
The James Graham Brown Cancer Center at University of LouisvilleLouisville, United StatesTaking people
UofL Health Medical Center NortheastLouisville, United StatesTaking people
University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterMadison, United StatesTaking people
University of Wisconsin Carbone Cancer Center - University HospitalMadison, United StatesTaking people
William S Middleton VA Medical CenterMadison, United StatesTaking people
North Shore University HospitalManhasset, United StatesTaking people
Carle Physician Group-Mattoon/CharlestonMattoon, United StatesTaking people
Loyola University Medical CenterMaywood, United StatesTaking people
Baptist Memorial Hospital and Cancer Center-MemphisMemphis, United StatesTaking people
Saint Luke's Cancer Institute - MeridianMeridian, United StatesTaking people
Miami Cancer InstituteMiami, United StatesTaking people
Memorial Sloan Kettering MonmouthMiddletown, United StatesTaking people
Medical College of WisconsinMilwaukee, United StatesTaking people
Abbott-Northwestern HospitalMinneapolis, United StatesTaking people
Community Medical CenterMissoula, United StatesTaking people
Kaiser Permanente- Modesto MOB IIModesto, United StatesTaking people
Kaiser Permanente-ModestoModesto, United StatesNo longer taking part
Memorial Sloan Kettering BergenMontvale, United StatesTaking people
Saint Alphonsus Cancer Care Center-NampaNampa, United StatesTaking people
Saint Luke's Cancer Institute - NampaNampa, United StatesTaking people
Baptist Memorial Hospital and Cancer Center-Union CountyNew Albany, United StatesTaking people
Rutgers Cancer Institute of New JerseyNew Brunswick, United StatesTaking people
Yale UniversityNew Haven, United StatesTaking people
UC Comprehensive Cancer Center at Silver CrossNew Lenox, United StatesTaking people
Memorial Sloan-Kettering Cancer CenterNew York, United StatesTaking people
Providence Newberg Medical CenterNewberg, United StatesTaking people
Henry Ford Medical Center-ColumbusNovi, United StatesNo longer taking part
Cancer Care Center of O'FallonO'Fallon, United StatesTaking people
Kaiser Permanente-OaklandOakland, United StatesTaking people
Saint Vincent Hospital Cancer Center at Oconto FallsOconto Falls, United StatesTaking people
University of Oklahoma Health Sciences CenterOklahoma City, United StatesTaking people
Saint Alphonsus Cancer Care Center-OntarioOntario, United StatesTaking people
Providence Willamette Falls Medical CenterOregon City, United StatesTaking people
Northwestern Medicine Orland ParkOrland Park, United StatesTaking people
University of Chicago Medicine-Orland ParkOrland Park, United StatesTaking people
University of Kansas Hospital-Indian Creek CampusOverland Park, United StatesTaking people
Baptist Memorial Hospital and Cancer Center-OxfordOxford, United StatesTaking people
The Valley Hospital - Luckow PavilionParamus, United StatesTaking people
Lahey Clinic PeabodyPeabody, United StatesTaking people
University of Pennsylvania/Abramson Cancer CenterPhiladelphia, United StatesTaking people
UPMC Hillman Cancer CenterPittsburgh, United StatesTaking people
Trinity Health Saint Joseph Mercy Oakland HospitalPontiac, United StatesTaking people
MaineHealth Maine Medical Center - PortlandPortland, United StatesTaking people
Providence Portland Medical CenterPortland, United StatesTaking people
Providence Saint Vincent Medical CenterPortland, United StatesTaking people
Kootenai Clinic Cancer Services - Post FallsPost Falls, United StatesTaking people
Rhode Island HospitalProvidence, United StatesTaking people
VCU Massey Comprehensive Cancer CenterRichmond, United StatesTaking people
Valley Health System Ridgewood CampusRidgewood, United StatesTaking people
University of RochesterRochester, United StatesTaking people
Kaiser Permanente-RosevilleRoseville, United StatesTaking people
Kaiser Permanente Downtown CommonsSacramento, United StatesTaking people
Kaiser Permanente-South SacramentoSacramento, United StatesTaking people
University of California Davis Comprehensive Cancer CenterSacramento, United StatesTaking people
Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, United StatesTaking people
Regions HospitalSaint Paul, United StatesTaking people
United HospitalSaint Paul, United StatesTaking people
George E. Wahlen Department of Veterans Affairs Medical CenterSalt Lake City, United StatesTaking people
Huntsman Cancer Institute/University of UtahSalt Lake City, United StatesTaking people
Kaiser Permanente-San FranciscoSan Francisco, United StatesTaking people
UCSF Medical Center-ParnassusSan Francisco, United StatesTaking people
Kaiser Permanente-Santa Teresa-San JoseSan Jose, United StatesTaking people
Kaiser Permanente San LeandroSan Leandro, United StatesTaking people
Mills Health CenterSan Mateo, United StatesNo longer taking part
Kaiser San Rafael-GallinasSan Rafael, United StatesTaking people
Kootenai Clinic Cancer Services - SandpointSandpoint, United StatesTaking people
Essentia Health SandstoneSandstone, United StatesTaking people
Kaiser Permanente Medical Center - Santa ClaraSanta Clara, United StatesTaking people
Kaiser Permanente-Santa RosaSanta Rosa, United StatesTaking people
MaineHealth Maine Medical Center- ScarboroughScarborough, United StatesTaking people
Fred Hutchinson Cancer CenterSeattle, United StatesTaking people
Swedish Medical Center-First HillSeattle, United StatesTaking people
University of Washington Medical Center - MontlakeSeattle, United StatesTaking people
Prisma Health Cancer Institute - SenecaSeneca, United StatesTaking people
Saint Vincent Hospital Cancer Center at SheboyganSheboygan, United StatesTaking people
Memorial Hospital EastShiloh, United StatesTaking people
MaineHealth Cancer Care and IV Therapy - South PortlandSouth Portland, United StatesTaking people
Kaiser Permanente-South San FranciscoSouth San Francisco, United StatesTaking people
Baptist Memorial Hospital and Cancer Center-DesotoSouthhaven, United StatesTaking people
Southern Illinois University School of MedicineSpringfield, United StatesTaking people
Springfield ClinicSpringfield, United StatesTaking people
Springfield Memorial HospitalSpringfield, United StatesTaking people
Siteman Cancer Center at Christian HospitalSt Louis, United StatesTaking people
Siteman Cancer Center-South CountySt Louis, United StatesTaking people
Washington University School of MedicineSt Louis, United StatesTaking people
Marshfield Medical Center-River Region at Stevens PointStevens Point, United StatesTaking people
Stony Brook University Medical CenterStony Brook, United StatesTaking people
Saint Vincent Hospital Cancer Center at Sturgeon BaySturgeon Bay, United StatesTaking people
State University of New York Upstate Medical UniversitySyracuse, United StatesTaking people
Community Medical CenterToms River, United StatesTaking people
Cotton O'Neil Cancer Center / Stormont Vail HealthTopeka, United StatesNo longer taking part
Banner University Medical Center - TucsonTucson, United StatesTaking people
University of Arizona Cancer Center-North CampusTucson, United StatesTaking people
Carle Cancer CenterUrbana, United StatesTaking people
Kaiser Permanente-VallejoVallejo, United StatesTaking people
Essentia Health Virginia ClinicVirginia, United StatesTaking people
Kaiser Permanente-Walnut CreekWalnut Creek, United StatesTaking people
Northwestern Medicine Cancer Center WarrenvilleWarrenville, United StatesTaking people
Henry Ford West Bloomfield HospitalWest Bloomfield, United StatesNo longer taking part
Veterans Affairs Connecticut Healthcare System-West Haven CampusWest Haven, United StatesTaking people
Reading HospitalWest Reading, United StatesTaking people
Marshfield Medical Center - WestonWeston, United StatesTaking people
University of Kansas Hospital-Westwood Cancer CenterWestwood, United StatesTaking people
Geisinger Wyoming Valley/Henry Cancer CenterWilkes-Barre, United StatesTaking people
Wake Forest University Health SciencesWinston-Salem, United StatesTaking people
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusYpsilanti, United StatesTaking people

Questions to ask the study team

How often do I need to come in, and for how long each time?
Are travel costs paid?
Can I keep my own doctor?
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Trial details

Who runs it: National Cancer Institute (NCI)
Trial code: NCT06317649
Record updated: 4 November 2026
Original description: This phase II MyeloMATCH treatment trial compares the usual treatment of azacitidine and venetoclax to the combination treatment of azacitidine, venetoclax and gilteritinib in treating older and unfit patients with acute myeloid leukemia and FLT3 mutations. Azacitidine is a drug that is absorbed into DNA and leads to the activation of cancer suppressor genes, which are genes that help control cell growth. 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. Gilteritinib is in a class of medications called kinase inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply. This study may help doctors find out if these different approaches are better than the usual approaches. To decide if they are better, the study doctors are looking to see if the study drugs lead to a higher percentage of patients achieving a deeper remission compared to the usual approach.Read full original descriptionShow less
A Randomized Phase II Study of Venetoclax and HMA-Based Therapies for the Treatment of Older and Unfit Adults With Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia (AML): A MyeloMATCH Substudy
This phase II MyeloMATCH treatment trial compares the usual treatment of azacitidine and venetoclax to the combination treatment of azacitidine, venetoclax and gilteritinib in treating older and unfit patients with acute myeloid leukemia and FLT3 mutations. Azacitidine is a drug that is absorbed into DNA and leads to the activation of cancer suppressor genes, which are genes that help control cell growth. 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. Gilteritinib is in a class of medications called kinase inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply. This study may help doctors find out if these different approaches are better than the usual approaches. To decide if they are better, the study doctors are looking to see if the study drugs lead to a higher percentage of patients achieving a deeper remission compared to the usual approach.
Inclusion: Patient must be ≥ 60 years of age or adults ˂ 60 who in the opinion of the treating physician are better served by azanucleoside-based therapy rather than intensive, cytarabine-based induction based on clinical status (i.e., performance status), organ dysfunction, or disease biology; Patient must have a morphologically confirmed diagnosis of AML as determined by the site and confirmed by the treatment verification team, excluding acute promyelocytic leukemia (APL) with PML-RARA, AML with RUNX1-RUNX1T1, or AML with CBFB-MYH11; Patient must have no prior therapy for AML with the exception of hydroxyurea, all-trans retinoic acid (ATRA), cytarabine-based emergency therapy or leukapheresis to ensure white blood cells (WBC) < 25,000/mm\^3 prior to starting venetoclax treatment; Patient must have no prior therapy with hypomethylating agents or FLT3 inhibitors; Patient must have the FLT3-ITD, D835, or I836del mutation based on MYELOMATCH Protocol; Patient must be assigned to this protocol by the MYELOMATCH Protocol; Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. Contraception measures must continue for 30 days after the last dose of venetoclax for all patients who are able to conceive or father children and for 6 months after the last dose of gilteritinib for patients of childbearing potential and for 4 months after the last dose of gilteritinib for male patients with partners of childbearing potential. Patient must not breastfeed during treatment and for 2 months after treatment ends; Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible; Total bilirubin ≤ 2 X institutional upper limit of normal (ULN), unless thought to be elevated due to disease involvement or Gilbert's syndrome, in which case bilirubin ≤ 3 x ULN is allowed (must be obtained ≤ 14 days prior to randomization); Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x institutional ULN (must be obtained ≤ 14 days prior to randomization); Creatinine clearance ≥ 30 mL/min (must be obtained ≤ 14 days prior to randomization); Either measured or estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation (2021); Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial; Patients who meet the criteria below must have had an electrocardiogram (ECG) performed with a corrected QT interval using Fridericia's correction (QTcF) interval within normal limits:; History of cardiac arrythmia, atrial fibrillation, or irregular QTcF interval OR; Known genetic predisposition to long QT syndrome OR; Risk for electrolyte abnormalities, including tumor lysis syndrome; Normal limits are QTcF ≤ 450 ms for males and QTcF ≤ 460 ms for females. Corrected QT interval method (QTcF) may follow institutional standards; NOTE: Since older patients and patients with cardiac disease are at risk for prolonged QTcF and many will require supportive care with agents that affect the QTcF, an ECG is recommended if clinically indicated as noted above. If the QTcF is prolonged (> 450 ms for males and > 460 ms for females), they should be treated on the Tier Advancement Pathway (TAP) instead of MM1OA-EA02. In patients where ECG is not clinically indicated, QTcF does not need to be documented; For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated; Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load; Patient must not have the medical necessity for ongoing treatment with a strong CYP3A4 inducing drug; Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial; Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2 or better; Patient must not have an uncontrolled infection.
ClinicalTrials.gov NCT06317649