Clinical Trial Goal
To find out if allogeneic BMT is safe and works well to treat PTCL that has relapsed or is refractory in adolescents and adults
You may be able to join this trial if you:
- Are 12 years old or older
- Have PTCL that has relapsed or is refractory. Some examples are:
- Anaplastic large cell lymphoma (ALCL)
- Angioimmunoblastic T-cell lymphoma (ATL)
- Enteropathy associated T-cell lymphoma
- Hepatosplenic T-cell lymphoma
- Gamma/delta T-cell lymphoma
- Peripheral T-cell lymphoma - not otherwise specified (PTCL-NOS)
- 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 and pentostatin are chemotherapy (chemo) drugs that block the growth of cancer.
Cyclophosphamide is a chemo drug that blocks the growth of cancer cells and helps prevent GVHD.
Granulocyte colony-stimulating factor (G-CSF) helps normal white blood cells recover from treatment.
Mycophenolate mofetil (MMF) and sirolimus are drugs that slows down the immune system.
Ruxolitinib is a small molecule inhibitor that blocks JAK1 and JAK2 in certain cells.
In this trial, you’ll be put in 1 of 2 groups. The clinical trial doctors will choose and will tell you which group you’re in based on what they think is best for your health:
Busulfan and pentostatin are chemotherapy (chemo) drugs that block the growth of cancer.
Cyclophosphamide is a chemo drug that blocks the growth of cancer cells and helps prevent GVHD.
Granulocyte colony-stimulating factor (G-CSF) helps normal white blood cells recover from treatment.
Mycophenolate mofetil (MMF) and sirolimus are drugs that slows down the immune system.
Ruxolitinib is a small molecule inhibitor that blocks JAK1 and JAK2 in certain cells.
In this trial, you’ll be put in 1 of 2 groups. The clinical trial doctors will choose and will tell you which group you’re in based on what they think is best for your health:
- Group 1 – Immunosuppression-only conditioning (IOC)
- Group 2 – Reduced-intensity conditioning (RIC)
- Group 3 – Modified RIC
- Group 4 – Modified RIC for individuals with ATL
First, you’ll get:
- ATG – Given as intravenous (IV) infusions 2 times. The dose you’ll get depends on what group you’re in
- Cyclophosphamide – A pill that you take by mouth 1 time each day for 8 days
- Pentostatin – Given as IV infusions 5 times
- Busulfan – Group 2 and Group 4 only – Given as IV infusions 2 times
- G-CSF – Group 3 and Group 4 only – Given as shots under your skin 3 times
- Ruxolitinib – Group 4 only – A pill that you take by mouth 1 time each day for about 2 weeks
On transplant day, the blood-forming cells from your donor will be given to you through an IV infusion.
After transplant, you’ll get standard drugs to help prevent graft-versus-host disease (GVHD). You’ll get:
- Cyclophosphamide – Given as IV infusions 2 times. The dose you’ll get depends on what group you’re in
- MMF – A pill that you take by mouth 1 time each day for about 3 weeks
- Sirolimus – A pill that you take by mouth 1 time each day for about 2 months
You’ll have scans and biopsies to see how well treatment is working. After transplant, the clinical trial doctors will check your health for 5 years.
The Food and Drug Administration (FDA) has approved all the drugs in this trial. Using them in this way with allogeneic BMT to treat PTCL is new and unproven.
Contacts
Jessenia C Campos, R.N., (240) 858-7492, jessenia.campos@nih.gov
Dimana Dimitrova, M.D., (240) 858-3647, dimana.dimitrova@nih.gov
Locations
National Institutes of Health Clinical CenterRECRUITING
Bethesda, Maryland
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office, 888-624-1937
National Marrow Donor ProgramENROLLING_BY_INVITATION
Minneapolis, Minnesota
Sponsors
lead: National Cancer Institute (NCI)
