Clinical Trial Goal
To compare 3 different ways to prevent GVHD after allogeneic BMT to treat blood cancer in children and adults
You may be able to join this trial if you:
- Are 1 - 60 years old
- Have one of the following diseases that has gone away with treatment (remission):
- ALL
- AML
- Biphenotypic leukemia
- Blastic plasmacytoid dendritic cell neoplasm (BPDCN)
- Burkitt leukemia/lymphoma
- Chronic myeloid leukemia (CML)
- Lymphoblastic lymphoma
- Mast cell leukemia
- Mixed phenotype acute leukemia
- Myelodysplastic syndrome (MDS)
- Other acute leukemia
- Are able to get an allogeneic BMT with intense (myeloablative) chemotherapy (chemo) and total body irradiation (TBI). Your doctor can tell you this
- Have not had a myeloablative autologous (your own cells) or allogeneic BMT
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Anti-thymocyte globulin (ATG) is a standard drug used to prevent GVHD.
Busulfan is a chemotherapy (chemo) drug that blocks the growth of cancer.
Cyclophosphamide is a chemotherapy (chemo) drug that helps prevent GVHD and blocks the growth of cancer cells.
Fludarabine and thiotepa are drugs that block growth of cancer cells.
Tacrolimus is a standard drug used to prevent GVHD.
In this trial, you’ll be randomized to 1 of 5 groups. Once you’re 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 or 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’re in Group 1, before BMT, you’ll get:
Busulfan is a chemotherapy (chemo) drug that blocks the growth of cancer.
Cyclophosphamide is a chemotherapy (chemo) drug that helps prevent GVHD and blocks the growth of cancer cells.
Fludarabine and thiotepa are drugs that block growth of cancer cells.
Tacrolimus is a standard drug used to prevent GVHD.
In this trial, you’ll be randomized to 1 of 5 groups. Once you’re 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 or 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’re in Group 1, before BMT, you’ll get:
- Fludarabine – Given as intravenous (IV) infusions 1 time each day for 5 days. Each infusion takes 30 minutes
- Tacrolimus – Given as an IV infusion starting the day of BMT
- Thiotepa – Given as IV infusions 1 time each day for 2 days. Each infusion takes 4 hours
- Total body irradiation (TBI) – A treatment done 2 times each day for 4 days to prepare your body for BMT
If you're in Group 2, before BMT, you'll get:
- Busulfan - Given as IV infusions 1 time each day for 3 days. Each infusion takes 3 hours
- Fludarabine - Given as IV infusions 1 time each day for 5 days. Each infusion takes 30 min
- TBI - A treatment done 2 times each day for 1 day to prepare your body for BMT
If you’re in Group 3, before BMT, you’ll get:
- TBI – A treatment done 2 times each day for 3 days to prepare your body for BMT
If you're in Group 4, before BMT, you'll get:
- Fludarabine - Given as IV infusions 1 time each day for 4 days. Each infusion takes 30 min
- Busulfan - Given as IV infusions 1 time each day for 3 days. Each infusion takes 3 hours
On transplant day, you’ll get the blood-forming cells from your donor, given to you as an IV infusion.
After transplant, you’ll get:
- Cyclophosphamide – Group 3 and 4 only - Given as IV infusions 1 time each day for 2 days. Each infusion takes 1 hour
- Donor lymphocyte infusion (DLI) – Group 1 and 2 only – Given as an IV infusion 1 time
- Methotrexate – Group 1 and 2 – Given as IV infusions 1 time each day for 4 days
- Tacrolimus - Given as IV infusions or a pill that you take by mouth for at least 2 months
You'll have biopsies to see how well the treatment is working. After you finish treatment, the clinical trial doctors will check your health for 2 years.
The Food and Drug Administration (FDA) has approved all of the drugs used in this trial. Using them in this way is new and unproven.
Locations
Moffitt Cancer CenterRECRUITING
Tampa, Florida
Taiga Nishihori, 813-745-4673, taiga.nishihori@moffitt.org
University of Pittsburgh Cancer Institute (UPCI)RECRUITING
Pittsburgh, Pennsylvania
Alison Sehgal, 412-623-2861, sehgalar@upmc.edu
Fred Hutch/University of Washington Cancer ConsortiumRECRUITING
Seattle, Washington
Marie Bleakley, 206-667-6572, mbleakle@fredhutch.org
Sponsors
collaborator: National Cancer Institute (NCI), lead: Fred Hutchinson Cancer Center
