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
Trial Details
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:
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 up to 5 years.
The Food and Drug Administration (FDA) has not yet approved Iomab-B. The FDA has approved all other drugs used in this trial.
Locations
Sponsors
lead: Actinium Pharmaceuticals
