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)Print
55 and older
Clinical Trial Goal
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
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.
Banner MD Anderson Cancer CenterRecruiting
Yale Cancer CenterRecruiting
New Haven, Connecticut
Loyola University Medical CenterRecruiting
The University of Kansas Cancer CenterRecruiting
Washington University School of MedicineRecruiting
Saint Louis, Missouri
University of Nebraska Medical CenterRecruiting
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
University Hospital of Cleveland Seidman Cancer CenterRecruiting
Baylor Charles A. Sammons Cancer CenterRecruiting
MD Anderson Cancer CenterRecruiting
Fred Hutchinson Cancer Research CenterRecruiting
Medical College of WisconsinRecruiting
lead: Actinium Pharmaceuticals