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Engineered donor graft (donor cells treated in lab) for people getting allogeneic (cells from a donor) blood or marrow transplant (BMT) to treat blood cancer

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18 - 65

Phase 1

8 Locations

NCT03802695

Clinical Trial Goal


To find out if an engineered donor graft is safe and works well to treat blood cancer for people getting an allogeneic BMT

You may be able to join this trial if you:


  • Are 18 – 65 years old
  • Have one of the following diseases:
    • Acute lymphocytic leukemia (ALL) that has gotten better after treatment (complete remission)
    • Acute myeloid leukemia (AML) in complete remission
    • Mixed phenotype leukemia in complete remission
    • Myelodysplastic syndrome (MDS) that doctors consider high risk
  • Are able to get an allogeneic BMT with intense (myeloablative) chemotherapy (chemo). Your doctor can tell you this
  • Have not had an allogeneic BMT
  • Agree to have other standard tests done to see if you can be in the clinical trial

Trial Details


Your donor’s blood-forming cells will be collected and treated in a lab. Doctors think that treating them in this way will help the donated cells grow and lower the chances of graft-versus-host disease (GVHD).

First, you’ll be treated with standard myeloablative chemo to prepare your body for transplant.

On transplant day, the treated blood-forming cells from your donor will be given to you as an intravenous (IV) infusion.

You’ll also get standard treatment to prevent GVHD.

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

The Food and Drug Administration (FDA) not yet approved this type of engineered donor graft in an allogeneic BMT to treat blood cancer.

Contacts


James S McClellan, MD, PhD, 1-530-414-9743, info@orcabiosystems.com

Locations

City of HopeRecruiting

Duarte, California
Amandeep Salhotra, MD

Stanford Health CareRecruiting

Stanford, California
Robert Lowsky, MD

UC DavisRecruiting

Sacramento, California
Mehrdad Abedi, MD

Emory UniversityRecruiting

Atlanta, Georgia
Edmund Waller, MD

The University of Kansas HospitalRecruiting

Kansas City, Kansas
Joseph McGuirk, MD

Ohio State UniversityRecruiting

Columbus, Ohio
Ayman Saad, MD

University of Texas MD Anderson Cancer CenterRecruiting

Houston, Texas
Samer Srour, MD

Froedtert Memorial Lutheran HospitalRecruiting

Milwaukee, Wisconsin
Sameem Abedin, MD, PhD

ClinicalTrials.gov record


NCT03802695

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