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Half-matched (haploidentical) blood or marrow transplant (BMT) with total marrow irradiation (TMI) to treat acute leukemia or myelodysplastic syndrome (MDS)

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Phase 2

1 Location

NCT04187105

Clinical Trial Goal


To find out if haploidentical BMT with TMI is safe and works well to treat acute leukemia or MDS

You may be able to join this trial if you:


  • Are 18-75 years old
  • Have been diagnosed with one of the following: 
    • Acute lymphoblastic leukemia (ALL)
    • Acute myeloid leukemia (AML)
    • MDS that doctors consider high-risk
  • Have a family member or a member of the public registry who is your half match and can be your donor. Your biological parents and children are always a half-match for you
  • Agree to have other standard tests done to see if you can be in the clinical trial

Trial Details


Cyclophosphamide is a chemotherapy (chemo) drug that helps prevent GVHD and blocks the growth of cancer cells.
Fludarabine is a chemo drug that blocks the growth of cancer cells.
Mycophenolate mofetil is a drug that slows down the immune system.
Total marrow irradiation (TMI) is a type of radiation therapy that targets bone marrow.
Tacrolimus is a standard drug used to prevent GVHD.

Before transplant, you’ll get standard treatment with the following:
  • Cyclophosphamide - Given as intravenous (IV) infusions 1 time each day for 2 days
  • Fludarabine - Given as IV infusions 1 time each day for 5 days
  • Total body irradiation (TBI) – A treatment done 1 time, the day before transplant to prepare your body for transplant
  • TMI – A procedure done two times each day for two days to prepare your body for transplant

On transplant day, the blood-forming cells from your donor are given to you through an IV infusion.

After transplant, you’ll get:
  • Cyclophosphamide – Given as IV infusions 1 time each day for 2 days 
  • Mycophenolate mofetil - A pill you take by mouth 3 times each day 
  • Tacrolimus - Given as IV infusions or as a pill you take by mouth 

You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for 1 year.  

The Food and Drug Administration (FDA) has approved haploidentical BMT and all of the drugs in this trial. 

Contacts


Rondelli Damiano, MD, 312-996-6179, drond@uic.edu

Marisol Vega, MS, 312-335-5035, vegam35@uic.edu

Locations


University of Illinois Cancer CenterRECRUITING

Chicago, Illinois
Contacts:

ClinicalTrials.gov record


NCT04187105. First posted on 12/5/19

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