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Allogeneic (cells from a donor) blood or marrow transplant (BMT) using cells from a deceased donor to treat acute leukemia 

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18 - 70

Phase 1, Phase 2

4 Locations

NCT05589896

Clinical Trial Goal


To find out if allogeneic BMT using cells from a deceased donor is safe and works well to treat acute leukemia

You may be able to join this trial if you:


  • Are 18 - 70 years old
  • Have one of the following:
    • Acute lymphoblastic leukemia (ALL)
    • Acute myeloid leukemia (AML)
    • Acute biophenotypic leukemia (ABL)
    • Acute undifferentiated leukemia (AUL)
  • Do not have a related or unrelated donor match available 
  • Have not had a BMT
  • Agree to have other standard tests done to see if you can be in the clinical trial

Trial Details


Busulfan and fludarabine are chemotherapy (chemo) drugs that block the growth of cancer.
Cyclophosphamide is a chemo drug that helps prevent GVHD.
Filgrastim is a drug that helps your white blood cells recover after chemo. 
Mycophenolate mofetil is a drug that slows down the immune system.
Tacrolimus is a standard drug used to prevent GVHD.

In this trial, you’ll be placed in 1 of 2 groups:
  • Group 1 – BMT with standard conditioning plus total body irradiation (TBI)
  • Group 2 - BMT with reduced intensity conditioning (RIC)

Before transplant, you’ll get standard treatment with a combination of the following:
  • Busulfan – Given as intravenous (IV) infusions
  • Fludarabine - Given as IV infusions
  • TBI 

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

After transplant, you’ll get:
  • Cyclophosphamide – Given as IV infusions
  • Filgrastim - Given as IV infusions or as a shot under your skin
  • Mycophenolate mofetil - A pill that you take by mouth
  • Tacrolimus - Given as IV infusions

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 all of the drugs used in this trial. Using deceased donor cells in BMT for acute leukemia is new and unproven.

Contacts


Matthew Flores, (763)406-3060, PRESERVE@nmdp.org

Preethi Prasad, MSc., preethi.prasad@ossiumhealth.com

Locations


Moffitt Cancer CenterRecruiting

Tampa, Florida
Eric Carrasquillo

Columbia University - Herbert Irving Comprehensive Cancer CenterRecruiting

New York, New York
Elizabeth Shelton, MPH

TriStar Bone Marrow TransplantRecruiting

Nashville, Tennessee
Yesenia Romero Herazo

St. David's South Austin Medical CenterRecruiting

Austin, Texas
Stephanie Goldin

ClinicalTrials.gov record


NCT05589896. First posted on 10/21/22

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