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Allogeneic (cells from a donor) blood or marrow transplant (BMT) with reduced-intensity chemotherapy (chemo) to treat blood cancers

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18 and older

Phase 2

1 Location

NCT05031897

Clinical Trial Goal


To find out if allogeneic BMT with reduced-intensity chemo and DLI are safe and work well to treat blood cancers.


You may be able to join this trial if you:


  • Are 18 years old or older
  • Have a blood cancer that can be treated with allogeneic BMT
  • Has a matched unrelated donor that is a 7/8 or 8/8 match. Your doctor can tell you this
  • Agree to have other standard tests done to see if you can be in the clinical trial

Trial Details


Cyclophosphamide is a drug that helps prevent GVHD
Fludarabine is a drug that blocks the growth of cancer cells.
Melphalan is a drug that blocks the growth of cancer cells.
Mycophenolate mofetil is a drug that slows down the immune system.
Tacrolimus is a standard drug used to prevent GVHD.

Before transplant, you’ll get treatment with the following:
  • Cyclophosphamide – Given as an intravenous (IV) infusion one time each day for 2 days
  • DLI – Lymphocytes (a type of white blood cell) from your donor given as an IV infusion 1 time 
  • Fludarabine – Given as an IV infusion 1 time each day for 4 days
  • Melphalan – Group 2 only - Given as an IV infusion 1 time each day for 2 days
  • Total Body Irradiation (TBI) – A treatment done 1 or 4 times before BMT to prepare your body for transplant
  • Mycophenolate mofetil – Given as an IV infusion 1 time
  • Tacrolimus – Given as an IV infusion 1 time 

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

You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 2 years.

The Food and Drug Administration (FDA) has approved allogeneic BMT to treat blood cancers. Getting DLI before allogeneic BMT with reduced-intensity chemo is new and unproven.

Contacts


Usama Gergis, MD, 215-503-2455, usama.gergis@jefferson.edu

Locations


Sidney Kimmel Cancer Center at Thomas Jefferson UniversityRECRUITING

Philadephia, Pennsylvania
Usama Gergis, MD, 215-503-2455, usama.gergis@jefferson.edu

ClinicalTrials.gov record


NCT05031897. First posted on 9/2/21

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