Testing the Addition of Venetoclax or Gemtuzumab Ozogamicin (GO) to Usual Treatment Regimen (Cytarabine and Daunorubicin, "7+3") for Core Binding Factor Acute Myeloid Leukemia (CBF-AML) to Improve Response (A MYELOMATCH Treatment Trial)
Phase II Study of Cytarabine + Daunorubicin (7 + 3) + Gemtuzumab Ozogamicin vs. Cytarabine + Daunorubicin (7 + 3) + Venetoclax for the Treatment of Newly Diagnosed Core Binding Factor Acute Myeloid Leukemia (CBF-AML) in Younger Adults: A MyeloMATCH Substudy
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 59 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 2 years
- Procedures mentioned: Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Patients undergo echocardiography or multigated acquisition (MUGA) scan during screening, as well as bone marrow aspiration and blood sample collection throughout the study."
- "Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration, as well as blood sample collection throughout the study."
- "After completion of study treatment, patients are followed up at relapse and every 3 months for 2 years, then every 6 months until 5 years."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study is for adults ages 18–59 with core binding factor acute myeloid leukemia (CBF-AML), a type of blood cancer. It compares adding venetoclax or gemtuzumab ozogamicin to the usual chemotherapy drugs, cytarabine and daunorubicin. Researchers want to see whether venetoclax has fewer side effects and works as well as or better than the other treatment.
This phase II MYELOMATCH treatment trial compares the effect of venetoclax to gemtuzumab ozogamicin, when given with cytarabine and daunorubicin ("7+3" regimen), for the treatment of patients with core binding factor acute myeloid leukemia (CBF-AML). 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. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to an antitumor antibiotic drug, called ozogamicin. Gemtuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD33 receptors, and delivers ozogamicin to kill them. Chemotherapy drugs, such as cytarabine and daunorubicin work in different ways to stop the growth of cancer cells either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax with cytarabine and daunorubicin may have fewer side effects and be as effective or better than the combination with gemtuzumab ozogamicin in treating patients with core binding factor AML.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be ages 18–59, enrolled in MYELOMATCH screening, and assigned to this study by its treatment team.
- Have CBF-AML with one of the listed gene changes involving chromosomes 8 and 21 or chromosome 16, and no FLT3 gene change.
- Generally, have had no treatment for AML or myelodysplastic syndrome (MDS), a bone marrow disease. Some treatments are allowed, including urgent treatment to lower white blood cells and chemotherapy into spinal fluid.
- Meet the study’s limits for daily activity, liver tests, and kidney function. If you have heart disease, symptoms, or past treatment that can harm the heart, you must also meet its heart function rules.
- AML that follows another blood disease or past cancer treatment is allowed. Another cancer is allowed if it will not affect study safety or results.
- AML in the brain or spinal cord is allowed. It will be treated with chemotherapy given into the fluid around them.
- If you have HIV or hepatitis B, meet the study’s treatment rules and have no virus detected on required tests. Hepatitis C must be cured, or be under treatment with no virus detected.
- If you can become pregnant, have a negative urine or blood pregnancy test within 7 days before signing up.
Who can't join
- Are pregnant or breastfeeding.
- Have a medical condition that keeps you from swallowing the study medicines.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * GENERAL MYELOMATCH CRITERIA: Patients must be registered to the Master Screening and Reassessment Protocol, MYELOMATCH, and assigned to this protocol by the MATCHBox Treatment Verification Team * GENERAL MYELOMATCH CRITERIA: Participants must not have received prior anti-cancer therapy for AML or myelodysplastic syndrome (MDS) * Note: Hydroxyurea to control the white blood cell count (WBC) and cytarabine up to 1g for urgent cytoreduction is allowed. * Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility * GENERAL MYELOMATCH CRITERIA: Participants must not receive any cytarabine-containing therapy other than up to 1g of cytarabine, which is allowed for urgent cytoreduction. Hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide is allowed * Diagnosis of AML with t(8;21)(q22;q22.1)/RUNX1::RUNX1T1 or AML with inv(16)(p13.1q22) or t(16;16)(p13.1;q22)/CBFB::MYH11. No FLT3 mutation (these patients should be considered for a FLT3-focused MYELOMATCH study) * Secondary CBF-AML (e.g., prior pre-leukemic hematologic malignancy or history of chemotherapy/radiation therapy) is allowed. * No prior AML or MDS-directed therapy except for urgent treatment of leukocytosis with leukapheresis, cytarabine, and hydroxyurea, Prior intrathecal chemotherapy for central nervous system (CNS) involvement of AML is permitted * Age 18-59 years * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3 * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless patient has a history of Gilbert syndrome and direct bilirubin is ≤ 1.5 x ULN) * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x upper limit of normal (ULN) * Glomerular filtration rate (GFR) ≥ 30 mL/min/1.73m\^2 * Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done ≤ 7 days prior to registration is required * 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 * Participants with CNS disease are eligible for this trial and will be treated according to institutional guidelines with intrathecal chemotherapy for this aspect of their disease * Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial * 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 * 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 II or better * No known medical condition causing an inability to swallow oral formulations of agents
Study sites (72)
AL
- University of Alabama at Birmingham Cancer Center · Birmingham, AL 35233Site Public Contact · Study contact · gingerreeves@uabmc.eduRazan Mohty · Principal investigatorMore trials in Birmingham
CA
- UC San Diego Moores Cancer Center · La Jolla, CA 92093Site Public Contact · Study contact · 858-822-5354 · cancercto@ucsd.eduTiffany N. Tanaka · Principal investigatorMore trials in La Jolla
FL
- Memorial Hospital West · Pembroke Pines, FL 33028Site Public Contact · Study contact · 954-265-4325Yehuda E. Deutsch · Principal investigatorMore trials in Pembroke Pines
ID
- Kootenai Health - Coeur d'Alene · Coeur d'Alene, ID 83814Site Public Contact · Study contact · 406-969-6060 · mccinfo@mtcancer.orgJohn M. Schallenkamp · Principal investigatorMore trials in Coeur d'Alene
- Kootenai Clinic Cancer Services - Post Falls · Post Falls, ID 83854Site Public Contact · Study contact · 406-969-6060 · mccinfo@mtcancer.orgJohn M. Schallenkamp · Principal investigatorMore trials in Post Falls
- Kootenai Clinic Cancer Services - Sandpoint · Sandpoint, ID 83864Site Public Contact · Study contact · 406-969-6060 · mccinfo@mtcancer.orgJohn M. Schallenkamp · Principal investigatorMore trials in Sandpoint
IL
- Northwestern University · Chicago, IL 60611Site Public Contact · Study contact · 312-695-1301 · cancer@northwestern.eduYuchen Liu · Principal investigatorMore trials in Chicago
KS
- University of Kansas Clinical Research Center · Fairway, KS 66205Site Public Contact · Study contact · 913-588-3671 · KUCC_Navigation@kumc.eduJesus Gonzalez Lugo · Principal investigatorMore trials in Fairway
- University of Kansas Cancer Center · Kansas City, KS 66160Site Public Contact · Study contact · 913-588-3671 · KUCC_Navigation@kumc.eduJesus Gonzalez Lugo · Principal investigatorMore trials in Kansas City
- University of Kansas Hospital-Indian Creek Campus · Overland Park, KS 66211Site Public Contact · Study contact · 913-588-3671 · KUCC_Navigation@kumc.eduJesus Gonzalez Lugo · Principal investigatorMore trials in Overland Park
- University of Kansas Hospital-Westwood Cancer Center · Westwood, KS 66205Site Public Contact · Study contact · 913-588-3671 · KUCC_Navigation@kumc.eduJesus Gonzalez Lugo · Principal investigatorMore trials in Westwood
KY
- University of Kentucky/Markey Cancer Center · Lexington, KY 40536Site Public Contact · Study contact · 859-257-3379Fevzi Yalniz · Principal investigatorMore trials in Lexington
- The James Graham Brown Cancer Center at University of Louisville · Louisville, KY 40202Site Public Contact · Study contact · 502-562-3429Mohamed M. Hegazi · Principal investigatorMore trials in Louisville
- UofL Health Medical Center Northeast · Louisville, KY 40245Site Public Contact · Study contact · 502-852-2755 · ctoinfo@louisville.eduMohamed M. Hegazi · Principal investigatorMore trials in Louisville
LA
- Our Lady of the Lake Physician Group · Baton Rouge, LA 70808Site Public Contact · Study contact · 225-765-7659 · research@ololrmc.comHarry G. Sequeira Gross · Principal investigatorMore trials in Baton Rouge
MA
- Tufts Medical Center · Boston, MA 02111Site Public Contact · Study contact · 617-636-5000 · ContactUsCancerCenter@TuftsMedicalCenter.orgAndreas K. Klein · Principal investigatorMore trials in Boston
- Dana-Farber Cancer Institute · Boston, MA 02215Site Public Contact · Study contact · 877-442-3324Eric S. Winer · Principal investigatorMore trials in Boston
MI
- Trinity Health IHA Medical Group Hematology Oncology - Brighton · Brighton, MI 48114Site Public Contact · Study contact · 734-712-7251 · MCRCwebsitecontactform@stjoeshealth.orgTareq Al baghdadi · Principal investigatorMore trials in Brighton
- Trinity Health IHA Medical Group Hematology Oncology - Canton · Canton, MI 48188Site Public Contact · Study contact · 734-712-7251 · MCRCwebsitecontactform@stjoeshealth.orgTareq Al baghdadi · Principal investigatorMore trials in Canton
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital · Chelsea, MI 48118Site Public Contact · Study contact · 734-712-7251 · MCRCwebsitecontactform@stjoeshealth.orgTareq Al baghdadi · Principal investigatorMore trials in Chelsea
- Trinity Health Saint Mary Mercy Livonia Hospital · Livonia, MI 48154Site Public Contact · Study contact · 734-712-7251 · MCRCwebsitecontactform@stjoeshealth.orgTareq Al baghdadi · Principal investigatorMore trials in Livonia
- Trinity Health Saint Joseph Mercy Oakland Hospital · Pontiac, MI 48341Site Public Contact · Study contact · 734-712-7251 · MCRCwebsitecontactform@stjoeshealth.orgTareq Al baghdadi · Principal investigatorMore trials in Pontiac
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus · Ypsilanti, MI 48197Site Public Contact · Study contact · 734-712-7251 · MCRCwebsitecontactform@stjoeshealth.orgTareq Al baghdadi · Principal investigatorMore trials in Ypsilanti
MO
- Siteman Cancer Center at Saint Peters Hospital · City of Saint Peters, MO 63376Site Public Contact · Study contact · 800-600-3606 · info@siteman.wustl.eduRamzi Abboud · Principal investigatorMore trials in City of Saint Peters
- Siteman Cancer Center at West County Hospital · Creve Coeur, MO 63141Site Public Contact · Study contact · 800-600-3606 · info@siteman.wustl.eduRamzi Abboud · Principal investigatorMore trials in Creve Coeur
- Washington University School of Medicine · St Louis, MO 63110Site Public Contact · Study contact · 800-600-3606 · info@siteman.wustl.eduRamzi Abboud · Principal investigatorMore trials in St Louis
- Siteman Cancer Center-South County · St Louis, MO 63129Site Public Contact · Study contact · 800-600-3606 · info@siteman.wustl.eduRamzi Abboud · Principal investigatorMore trials in St Louis
- Siteman Cancer Center at Christian Hospital · St Louis, MO 63136Site Public Contact · Study contact · 800-600-3606 · info@siteman.wustl.eduRamzi Abboud · Principal investigatorMore trials in St Louis
MS
- Baptist Memorial Hospital and Cancer Center-Golden Triangle · Columbus, MS 39705Site Public Contact · Study contact · 901-226-1366 · BCCclintrials@bmhcc.orgSalil Goorha · Principal investigatorMore trials in Columbus
- Baptist Cancer Center-Grenada · Grenada, MS 38901Site Public Contact · Study contact · 901-226-1366 · BCCclintrials@bmhcc.orgSalil Goorha · Principal investigatorMore trials in Grenada
- Baptist Memorial Hospital and Cancer Center-Union County · New Albany, MS 38652Site Public Contact · Study contact · 901-226-1366 · BCCclintrials@bmhcc.orgSalil Goorha · Principal investigatorMore trials in New Albany
- Baptist Memorial Hospital and Cancer Center-Oxford · Oxford, MS 38655Site Public Contact · Study contact · 901-226-1366 · BCCclintrials@bmhcc.orgSalil Goorha · Principal investigatorMore trials in Oxford
- Baptist Memorial Hospital and Cancer Center-Desoto · Southhaven, MS 38671Site Public Contact · Study contact · 901-226-1366 · BCCclintrials@bmhcc.orgSalil Goorha · Principal investigatorMore trials in Southhaven
MT
- Billings Clinic Cancer Center · Billings, MT 59101Site Public Contact · Study contact · 800-996-2663 · research@billingsclinic.orgJohn M. Schallenkamp · Principal investigatorMore trials in Billings
- Bozeman Health Deaconess Hospital · Bozeman, MT 59715Site Public Contact · Study contact · 406-969-6060 · mccinfo@mtcancer.orgJohn M. Schallenkamp · Principal investigatorMore trials in Bozeman
- Benefis Sletten Cancer Institute · Great Falls, MT 59405Site Public Contact · Study contact · 406-969-6060 · mccinfo@mtcancer.orgJohn M. Schallenkamp · Principal investigatorMore trials in Great Falls
- Logan Health Medical Center · Kalispell, MT 59901Site Public Contact · Study contact · 406-969-6060 · mccinfo@mtcancer.orgJohn M. Schallenkamp · Principal investigatorMore trials in Kalispell
- Community Medical Center · Missoula, MT 59804Site Public Contact · Study contact · 406-969-6060 · mccinfo@mtcancer.orgJohn M. Schallenkamp · Principal investigatorMore trials in Missoula
NC
- Duke University Medical Center · Durham, NC 27710Site Public Contact · Study contact · 888-275-3853Harry P. Erba · Principal investigatorMore trials in Durham
NE
- Nebraska Medicine-Bellevue · Bellevue, NE 68123Site Public Contact · Study contact · 402-559-6941 · unmcrsa@unmc.eduMichael Haddadin · Principal investigatorMore trials in Bellevue
- Nebraska Medicine-Village Pointe · Omaha, NE 68118Site Public Contact · Study contact · 402-559-5600Michael Haddadin · Principal investigatorMore trials in Omaha
- University of Nebraska Medical Center · Omaha, NE 68198Site Public Contact · Study contact · 402-559-6941 · unmcrsa@unmc.eduMichael Haddadin · Principal investigatorMore trials in Omaha
NM
- University of New Mexico Cancer Center · Albuquerque, NM 87106Site Public Contact · Study contact · 505-925-0348 · HSC-ClinicalTrialInfo@salud.unm.eduCharles Foucar · Principal investigatorMore trials in Albuquerque
NY
- Roswell Park Cancer Institute · Buffalo, NY 14263Site Public Contact · Study contact · 800-767-9355 · askroswell@roswellpark.orgEunice S. Wang · Principal investigatorMore trials in Buffalo
- University of Rochester · Rochester, NY 14642Site Public Contact · Study contact · 585-275-5830Bassil Botros · Principal investigatorMore trials in Rochester
- State University of New York Upstate Medical University · Syracuse, NY 13210Site Public Contact · Study contact · 315-464-5476Teresa C. Gentile · Principal investigatorMore trials in Syracuse
- Montefiore Medical Center - Moses Campus · The Bronx, NY 10467Site Public Contact · Study contact · 718-379-6866 · eskwak@montefiore.orgIoannis Mantzaris · Principal investigatorMore trials in The Bronx
OH
- Ohio State University Comprehensive Cancer Center · Columbus, OH 43210Site Public Contact · Study contact · 800-293-5066 · Jamesline@osumc.eduAlice S. Mims · Principal investigatorMore trials in Columbus
OK
- University of Oklahoma Health Sciences Center · Oklahoma City, OK 73104Site Public Contact · Study contact · 405-271-8777 · ou-clinical-trials@ouhsc.eduZimu Gong · Principal investigatorMore trials in Oklahoma City
PA
- Geisinger Medical Center · Danville, PA 17822Site Public Contact · Study contact · 570-271-5251 · cancerresearch@geisinger.eduJoseph J. Vadakara · Principal investigatorMore trials in Danville
- Geisinger Wyoming Valley/Henry Cancer Center · Wilkes-Barre, PA 18711Site Public Contact · Study contact · 570-271-5251 · HemonCCTrials@geisinger.eduJoseph J. Vadakara · Principal investigatorMore trials in Wilkes-Barre
RI
- Rhode Island Hospital · Providence, RI 02903Site Public Contact · Study contact · 401-444-1488John L. Reagan · Principal investigatorMore trials in Providence
SC
- Prisma Health Cancer Institute - Spartanburg · Boiling Springs, SC 29316Site Public Contact · Study contact · 864-522-4317 · Kim.Williams3@prismahealth.orgSuzanne R. Fanning · Principal investigatorMore trials in Boiling Springs
- Prisma Health Cancer Institute - Easley · Easley, SC 29640Site Public Contact · Study contact · 864-522-4317 · Kim.Williams3@prismahealth.orgSuzanne R. Fanning · Principal investigatorMore trials in Easley
- Prisma Health Cancer Institute - Butternut · Greenville, SC 29605Site Public Contact · Study contact · 864-522-4317 · Kim.Williams3@prismahealth.orgSuzanne R. Fanning · Principal investigatorMore trials in Greenville
- Prisma Health Cancer Institute - Faris · Greenville, SC 29605Site Public Contact · Study contact · 864-522-4317 · Kim.Williams3@prismahealth.orgSuzanne R. Fanning · Principal investigatorMore trials in Greenville
- Prisma Health Cancer Institute - Eastside · Greenville, SC 29615Site Public Contact · Study contact · 864-522-4317 · Kim.Williams3@prismahealth.orgSuzanne R. Fanning · Principal investigatorMore trials in Greenville
- Prisma Health Cancer Institute - Greer · Greer, SC 29650Site Public Contact · Study contact · 864-522-4317 · Kim.Williams3@prismahealth.orgSuzanne R. Fanning · Principal investigatorMore trials in Greer
- Prisma Health Cancer Institute - Seneca · Seneca, SC 29672Site Public Contact · Study contact · 864-522-4317 · Kim.Williams3@prismahealth.orgSuzanne R. Fanning · Principal investigatorMore trials in Seneca
TN
- Baptist Memorial Hospital and Cancer Center-Collierville · Collierville, TN 38017Site Public Contact · Study contact · 901-226-1366 · BCCclintrials@bmhcc.orgSalil Goorha · Principal investigatorMore trials in Collierville
- Baptist Memorial Hospital and Cancer Center-Memphis · Memphis, TN 38120Site Public Contact · Study contact · 901-226-1366 · BCCclintrials@bmhcc.orgSalil Goorha · Principal investigatorMore trials in Memphis
UT
- Huntsman Cancer Institute/University of Utah · Salt Lake City, UT 84112Site Public Contact · Study contact · 888-424-2100 · cancerinfo@hci.utah.eduPaul J. Shami · Principal investigatorMore trials in Salt Lake City
VA
- VCU Massey Comprehensive Cancer Center · Richmond, VA 23298Site Public Contact · Study contact · 804-628-6430 · CTOclinops@vcu.eduKeri R. Maher · Principal investigatorMore trials in Richmond
WA
- Swedish Cancer Institute-Edmonds · Edmonds, WA 98026Site Public Contact · Study contact · 206-215-2343 · PCRC-NCORP@Swedish.orgAlison K. Conlin · Principal investigatorMore trials in Edmonds
- Swedish Cancer Institute-Issaquah · Issaquah, WA 98029Site Public Contact · Study contact · 206-215-2343 · PCRC-NCORP@Swedish.orgAlison K. Conlin · Principal investigatorMore trials in Issaquah
- Swedish Medical Center-First Hill · Seattle, WA 98122Site Public Contact · Study contact · 206-215-2343 · PCRC-NCORP@Swedish.orgAlison K. Conlin · Principal investigatorMore trials in Seattle
WI
- Gundersen Lutheran Medical Center · La Crosse, WI 54601Site Public Contact · Study contact · 608-775-2385 · cancerctr@gundersenhealth.orgMichael O. Ojelabi · Principal investigatorMore trials in La Crosse
- Froedtert Menomonee Falls Hospital · Menomonee Falls, WI 53051Site Public Contact · Study contact · 262-257-5100Ehab L. Atallah · Principal investigatorMore trials in Menomonee Falls
- Medical College of Wisconsin · Milwaukee, WI 53226Site Public Contact · Study contact · 414-805-3666Ehab L. Atallah · Principal investigatorMore trials in Milwaukee
- Froedtert and MCW Moorland Reserve Health Center · New Berlin, WI 53151Site Public Contact · Study contact · 414-805-0505Ehab L. Atallah · Principal investigatorMore trials in New Berlin
- Drexel Town Square Health Center · Oak Creek, WI 53154Site Public Contact · Study contact · 414-805-0505Ehab L. Atallah · Principal investigatorMore trials in Oak Creek
- Froedtert West Bend Hospital/Kraemer Cancer Center · West Bend, WI 53095Site Public Contact · Study contact · 414-805-0505Ehab L. Atallah · Principal investigatorMore trials in West Bend