Clinical Trial Goal
To find out:
- The highest dose of 211At-BC8-B10 that’s safe to give
- If 211At-BC8-B10 and allogeneic BMT are safe and works well to treat ALL, AML, CMML, MDS or MPAL
You may be able to join this trial if you:
- Are 18 - 75 years old
- Have one of the following diseases:
- ALL, AML or MPAL that has come back (relapsed) or has not gotten better with treatment (refractory)
- AML that came from another disease such as MDS
- CMML
- MDS type called refractory anemia with excess blasts (RAEB)
- Have leukemia cells with CD45 markers (CD45+). Your doctor can tell you this. If the leukemia is in remission, you do not need to have CD45 markers
- Have a fully matched related or unrelated donor
- Have not had an allogeneic BMT
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
211At-BC8-B10 is an antibody radionuclide conjugate that targets CD45 on certain cells and uses a radioactive molecule to destroy it.
Cyclosporine and mycophenolate mofetil are drugs that slow down the immune system.
Fludarabine is a drug that blocks growth of cancer cells.
First, you’ll get:
Cyclosporine and mycophenolate mofetil are drugs that slow down the immune system.
Fludarabine is a drug that blocks growth of cancer cells.
First, you’ll get:
- 211At-BC8-B10 – Given as an intravenous (IV) infusion 1 time. The infusion takes up to 8 hours. The dose you’ll get depends on when you start the trial and how safe it has been
- Cyclosporine – Given as IV infusions or a pill you take by mouth 2 times each day for 3 days
- Fludarabine – Given as IV infusions 1 time each day for 3 days. Each infusion takes 30 minutes
On transplant day, you’ll get:
- Total body irradiation (TBI) - A treatment done 1 time to prepare your body for transplant
- Blood-forming cells from your donor – Given as an IV infusion
After transplant, you’ll get standard drugs to help prevent graft-versus-host disease (GVHD):
- Cyclosporine – Given as IV infusions or a pill you take by mouth 2 times each day for about 6 months
- Mycophenolate mofetil – Given as IV infusions or a pill you take by mouth 2 - 3 times each day for about 1 month
You’ll have biopsies to see how well treatment is working. The clinical trial doctors will check your health for up to 2 years.
The Food and Drug Administration (FDA) has not yet approved 211At-BC8-BC10. The FDA has approved all of the other drugs used in this trial.
The Food and Drug Administration (FDA) has not yet approved 211At-BC8-BC10. The FDA has approved all of the other drugs used in this trial.
Locations
Fred Hutch/University of Washington Cancer ConsortiumRECRUITING
Seattle, Washington
Brenda M. Sandmaier, 206-667-4961, bsandmai@fredhutch.org
Sponsors
collaborator: National Cancer Institute (NCI), lead: Fred Hutchinson Cancer Center
