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A drug, ziftomenib, with other standard chemotherapy (chemo) drugs, to treat acute myeloid leukemia (AML)

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18 and older

Phase 1

44 Locations

NCT05735184

Clinical Trial Goal


To find out:
  • The highest dose of ziftomenib that’s safe to give with other standard chemo
  • If the combination of ziftomenib and other standard chemo is safe and works well to treat AML

You may be able to join this trial if you:


  • Are 18 years old or older
  • Have AML
  • Have leukemia cells with NPM1 mutation or KMT2A rearrangement. Your doctor can tell you this
  • Do not have acute promyelocytic leukemia or chronic myelomonocytic leukemia
  • Do not have untreated leukemia cells in your brain or spinal cord
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


Azacitidine is a drug that blocks the growth of cancer cells.
Cytarabine and daunorubicin are chemotherapy (chemo) drugs that block the growth of cancer cells.
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.
Ziftomenib is a small molecule inhibitor that blocks KMT2A in certain cells.  

You will get: 
  • Ziftomenib – A pill you take by mouth. The dose you'll get depends on when you start the trial and how safe it has been
 
The other drugs you get will depend on whether:
  • Your leukemia cells have NPM1 mutation or KMT2A rearrangement 
  • Your AML is newly diagnosed or it has come back (relapsed) or not gotten better with treatment (refractory) 

You'll also get 1 or 2 of these drugs: 
  • Azacitidine – Given as a shot under your skin or an intravenous (IV infusion). 
  • Cytarabine – Given as an IV infusion.
  • Daunorubicin – Given as an IV infusion.
  • Venetoclax – A pill you take by mouth. 

You may continue treatment for as long as the clinical trial doctors think it’s best for your health. You'll have biopsies and/or scans to see how well the treatment is working. The clinical trial doctors will check your health for up to 1 year after you stop treatment.

The Food and Drug Administration (FDA) has approved all of the drugs used in this trial. Using them in this way to treat AML is new and unproven.

Contacts


Clinical Operations, 617-588-3755, KO-MEN-007@kuraoncology.com

Locations

Mayo Clinic - PhoenixRECRUITING

Phoenix, Arizona
Clinical Trials Referral Office, 855-776-0015

Moores UC San Diego Cancer CenterRECRUITING

La Jolla, California
Krisma Montalvo, k1montalvo@health.ucsd.edu

UC Irvine Health Chao Family Comprehensive Cancer CenterRECRUITING

Orange, California
Research Line, 877-827-8839, ucstudy@hs.uci.edu

UCLA - Bowyer Oncology CenterRECRUITING

Los Angeles, California
Bruck Habtemariam, 310-794-0242, bhabtemariam@mednet.ucla.edu

USC / Norris Comprehensive Cancer CenterRECRUITING

Los Angeles, California
Christine Duran, 323-865-0371, duran_c@med.usc.edu

Colorado Blood Cancer InstituteRECRUITING

Denver, Colorado
Patient Clinic, 720-754-4800, PSLMDLCBCINewClinicPatient@HCAHealthcare.com

University of ColoradoRECRUITING

Aurora, Colorado

Yale Cancer Center and Smilow Cancer HospitalRECRUITING

New Haven, Connecticut
Farah Fasihuddin, 203-737-3472, farah.fasihuddin@yale.edu

Mayo Clinic JacksonvilleRECRUITING

Jacksonville, Florida
Clinical Trials Referral Office, 855-776-0015

Emory Healthcare - The Emory ClinicRECRUITING

Atlanta, Georgia
Gigi Stoneback, gissela.blanco.stoneback@emory.edu

Georgia Cancer Center at Augusta UniversityRECRUITING

Augusta, Georgia
Amanda Spires, amspires@augusta.edu

Loyola University Medical CenterRECRUITING

Maywood, Illinois

Robert H. Lurie Comprehensive Cancer Center of Northwestern UniversityRECRUITING

Chicago, Illinois
312-695-9367, cancer@northwestern.edu

University of Iowa Hospitals & ClinicsRECRUITING

Iowa City, Iowa
Cena Jones, cena-jones@uiowa.edu

The University of Kansas Medical Center Research InstituteRECRUITING

Fairway, Kansas
Thania Medrano, 913-945-7552, CTNurseNav@kumc.edu

Norton Cancer Institute - St. MatthewsRECRUITING

Louisville, Kentucky
502-899-3366, leukemia-NCIResearch@nortonhealthcare.org

University of Kentucky Markey Cancer CenterRECRUITING

Louisville, Kentucky
Ashley Walton-Robbins, Ashley.Walton-Robbins@uky.edu

Ochsner MD Anderson Cancer CenterRECRUITING

Jefferson, Louisiana
Amanda Woolery, RN, 504-842-0275, amanda.woolery@ochsner.org

Johns Hopkins School of MedicineRECRUITING

Baltimore, Maryland
I. Gojo, igojo1@jhmi.edu

Massachusetts General HospitalRECRUITING

Boston, Massachusetts
Christine Connelly, 617-724-1124, cconnolly1@mgh.harvard.edu

UMass Chan Medical SchoolRECRUITING

Worcester, Massachusetts
508-856-3216, Cancer.research@umassmed.edu

Karmanos Cancer InstituteRECRUITING

Detroit, Michigan
Carmen Rush, 800-527-6266, rushc@karmanos.org

University of Michigan Comprehensive Cancer CenterRECRUITING

Ann Arbor, Michigan
Cancer AnswerLine, 800-865-1125, CancerAnswerLine@med.umich.edu

Mayo Clinic - RochesterRECRUITING

Rochester, Minnesota
Clinical Trials Referral Office, 855-776-0015

University of MinnesotaRECRUITING

Minneapolis, Minnesota

Hackensack University Medical CenterRECRUITING

Hackensack, New Jersey
Oncology Clinical Research Referral Office, 551-996-1777, OncologyResearchReferral@hmhn.org

Rutgers Cancer InstituteRECRUITING

New Brunswick, New Jersey
Anita Trupiano, ar2069@cinj.rutgers.edu

Columbia University Medical CenterRECRUITING

New York, New York
Research Nurse Navigator, 212-342-5162, cancerclinicaltrials@cumc.columbia.edu

Mount Sinai - Ruttenberg Treatment CenterRECRUITING

New York, New York
Tina Czaplinska, tina.czaplinska@mssm.edu

New York - Presbyterian / Weill Cornell MedicineRECRUITING

New York, New York
Tania J Curcio, tjc9003@med.cornell.edu

Roswell Park Comprehensive Cancer CenterRECRUITING

Buffalo, New York
877-275-7724, askrpci@roswellpark.org

Stony Brook University HospitalRECRUITING

Stony Brook, New York
Pushpa Talanki, 631-638-0815, Pushpa.Talanki@stonybrookmedicine.edu

Duke Blood Cancer CenterRECRUITING

Durham, North Carolina
Quinna Lawson, quinna.marshburn@duke.edu

Cleveland Clinic Taussig Cancer InstituteRECRUITING

Cleveland, Ohio
Cancer Answer Line, 866-223-8100, ADVANIA@ccf.org

The James Cancer Hospital and Solove Research InstituteRECRUITING

Columbus, Ohio
Hanna Cordes, Hanna.cordes@osumc.edu

University Hospitals Cleveland Medical CenterRECRUITING

Cleveland, Ohio
Sarah Gollwitzer, Sarah.Gollwitzer@UHhospitals.org

OU Health Stephenson Cancer CenterRECRUITING

Oklahoma City, Oklahoma
Cynthia Lowery, Cynthia-Lowery@ouhsc.edu

Hospital of the University of PennsylvaniaRECRUITING

Philadelphia, Pennsylvania
Contacts:

TriStar Bone Marrow TransplantRECRUITING

Nashville, Tennessee
Ask Sarah, 844-482-4812

MD Anderson Cancer CenterRECRUITING

Houston, Texas
Ramya Ganesh, 713-792-5640, rganesh@mdanderson.org

Sarah Cannon Research Institute - St. David's South Austin Medical Center / Texas Oncology South AustinRECRUITING

Austin, Texas
Amy Hammack, amy.hammack@sarahcannon.com

UT Southwestern - Simmons Cancer CenterRECRUITING

Dallas, Texas
Phase I Team, 214-648-7097, HemeTeam@groups.utsouthwestern.edu

Medical College of Wisconsin Cancer CenterRECRUITING

Milwaukee, Wisconsin
Medical College of WI Cancer Center Clinical Trials Office, 414-805-8900, cccto@mcw.edu

University of Wisconsin Hospital and ClinicsRECRUITING

Madison, Wisconsin
UW Cancer Connect, 800-622-8922, clinicaltrials@cancer.wisc.edu

ClinicalTrials.gov record


NCT05735184. First posted on 2/21/23

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