Clinical Trial Goal
To find out if allogeneic BMT with an unrelated mismatched donor and PTCy is safe and works well to treat blood cancers
You may be able to join this trial if you:
- Are 18 years old or older
- Have a blood cancer that can be treated with allogeneic BMT. Some examples are:
- Acute lymphoblastic leukemia (ALL)
- Acute myeloid leukemia (AML)
- Chronic lymphocytic leukemia (CLL)
- Chronic myeloid leukemia (CML)
- Myelodysplastic syndrome (MDS)
- Myeloproliferative neoplasm (MPN)
- Are planning to have an allogeneic BMT using an unrelated mismatched or half-matched (haploidentical) donor
- Do not have a 8/8 matched donor available. Your doctor can tell you this
- Have not had an allogeneic BMT
- Have not had an autologous (your own cells) BMT in the last 3 months
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Busulfan, cyclophosphamide, fludarabine and melphalan are chemotherapy (chemo) drugs that block the growth of cancer cells.
Mycophenolate mofetil is a drug that slows down the immune system.
In this trial, you’ll be assigned to 1 of 5 groups that receive the following before BMT:
- Group 1 – higher doses of busulfan and fludarabine
- Group 2 – fludarabine and TBI
- Group 3 – lower doses of busulfan and fludarabine
- Group 4 – lower doses of fludarabine and melphalan
- Group 5 – cyclophosphamide, fludarabine and TBI
Before transplant, you’ll get:
- Busulfan – Groups 1 and 3 only – Given as an intravenous (IV) infusion or a pill that you take by mouth 1 time each day for 2 or 4 days
- Cyclophosphamide– Groups 5 only – Given as an IV infusion 1 time each day for 2 days
- Fludarabine – Given as an IV infusion 1 time each day for 3 or 5 days
- Melphalan – Group 4 only – Given as an IV infusion 1 time the day before BMT
- Total body irradiation (TBI) – Groups 2 and 5 only - A treatment done 1 time the day before transplant
On transplant day, the blood-forming cells from your donor are given to you through an IV infusion.
After transplant, you’ll get:
- Lower-dose cyclophosphamide– Given as an IV infusion 1 time each day for 2 days
- Mesna – Group 5 only - Given as IV infusions for 30 minutes before and 3, 6 and 8 hours after cyclophosphamide
- Mycophenolate mofetil – Given as an IV infusion or a pill that you take by mouth starting 5 days after BMT for about 1 month
- Tacrolimus – Given as an IV infusion or a pill that you take by mouth starting 5 days after BMT for about 6 months
The clinical trial doctors will check your health for up to 1 year.
The Food and Drug Administration (FDA) has approved all of the drugs used in this trial.
Locations
Sponsors
collaborator: National Marrow Donor Program, lead: Center for International Blood and Marrow Transplant Research
