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A drug, Iomab-B, to treat acute myeloid leukemia (AML) that has come back (relapsed) or did not get better after treatment (relapsed) in older people having a bone or marrow transplant (BMT)

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55 and older

Phase 3

17 Locations

NCT02665065

Clinical Trial Goal


To find out if using Iomab-B before BMT is safe and works better for people with AML compared to standard BMT treatment

You may be able to join this trial if you:


  • Are 55 years of age or older 
  • Have AML that has relapsed or is refractory
  • Plan to have an allogeneic (using donor cells) BMT and have not had a BMT before 
  • Do not have acute promyelocytic leukemia
  • Agree to have other standard tests done to see if you can be in the clinical trial

Tests and Treatments


You’ll be randomized to 1 of 2 groups. If you are in the Iomab-B group, you’ll get Iomab-B plus reduced intensity conditioning with the chemotherapy drug, fludarabine, plus low-dose total body irradiation (TBI). If you are in the conventional care group, you’ll get standard chemotherapy (chemo) drugs. Once you are randomized, you’ll be told which group you’re in. 
 
Randomized means doctors will use a computer to assign you to either group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your doctor and the clinical trial doctor won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group. 
 
If you are in the Iomab-B group, you’ll get the following treatments: 
  • Iomab-B – A new but unproven drug given as an intravenous (IV) infusion that destroys leukemia cells and also prepares your bone marrow for transplant using a radioisotope (a small molecule that is radioactive). 
  • Fludarabine – A drug given as an IV infusion 1 time each day for 3 days before transplant. 
  • Low dose TBI – A treatment done 1 time on the day of transplant. 
  • BMT – Donated blood-forming cells are given to you through an IV infusion. 
  • Mycophenolate mofetil – A drug given as a pill 2 times each day for 3 or more months after transplant to help prevent graft-versus-host disease (GVHD). 
  • Cyclosporine or tacrolimus – A drug given as a pill or an IV infusion each day for 3 days before transplant. You’ll continue taking cyclosporine or tacrolimus for at least 6 months after transplant to help prevent GVHD
 
If you’re in the conventional care group, you’ll get standard treatment chosen by your doctor. If your health does not improve after 4 to 6 weeks of standard treatment, the clinical trial doctor may be able to move you to the Iomab-B group for additional treatment.

You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check on your health for 1 year.

The Food and Drug Administration (FDA) has not yet approved Iomab-B. The FDA has approved all other drugs used in this trial.

Contacts


Vijay Reddy, MD, vreddy@actiniumpharma.com

Farnoush Safavi, MD, fsafavi@actiniumpharma.com

Locations

Banner MD Anderson Cancer CenterRecruiting

Gilbert, Arizona

Yale Cancer CenterRecruiting

New Haven, Connecticut

Mayo ClinicRecruiting

Jacksonville, Florida

Loyola University Medical CenterRecruiting

Maywood, Illinois

The University of Kansas Cancer CenterRecruiting

Westwood, Kansas

Mayo ClinicRecruiting

Rochester, Minnesota

Washington University School of MedicineRecruiting

Saint Louis, Missouri

University of Nebraska Medical CenterRecruiting

Omaha, Nebraska

Memorial Sloan Kettering Cancer CenterRecruiting

New York, New York

Roswell Park Cancer InstituteRecruiting

Buffalo, New York

Stony Brook UniversityRecruiting

Stony Brook, New York

The Ohio State University Comprehensive Cancer CenterRecruiting

Columbus, Ohio

University Hospital of Cleveland Seidman Cancer CenterRecruiting

Cleveland, Ohio

Baylor Charles A. Sammons Cancer CenterRecruiting

Dallas, Texas

MD Anderson Cancer CenterRecruiting

Houston, Texas

Fred Hutchinson Cancer Research CenterRecruiting

Seattle, Washington

Medical College of WisconsinRecruiting

Milwaukee, Wisconsin

ClinicalTrials.gov record


NCT02665065

Questions? Contact our Clinical Trial Patient Education Specialist

1-888-814-8610
clinicaltrials@jcctp.org