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Allogeneic (cells from a donor) blood or marrow transplant (BMT) with an unrelated mismatched donor and post-transplant cyclophosphamide (PTCy) to treat blood cancers in children and adults

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1 and older

Phase 2

20 Locations

NCT04904588

Clinical Trial Goal


To find out if allogeneic BMT with an unrelated mismatched donor and PTCy is safe and works well to treat blood cancers in children and adults

You may be able to join this trial if you:


  • Are 1 year old or older
  • Have a blood cancer that can be treated with allogeneic BMT. Some examples are:
    • Acute lymphoblastic leukemia (ALL)
    • Acute myeloid leukemia (AML) 
    • Chronic lymphocytic leukemia (CLL)
    • Chronic myeloid leukemia (CML)
    • Myelodysplastic syndrome (MDS)
  • Are planning to have an allogeneic BMT using an unrelated mismatched or half-matched (haploidentical) donor
  • Do not have a 8/8 matched donor available. Your doctor can tell you this
  • Have not had an allogeneic BMT
  • Have not had an autologous (your own cells) BMT in the last 3 months
  • Agree to have other standard tests done to see if you can be in the clinical trial

Trial Details


Busulfan, cyclophosphamide, fludarabine and melphalan are chemotherapy (chemo) drugs that block the growth of cancer cells. 
Mycophenolate mofetil is a drug that slows down the immune system.

In this trial, you’ll be assigned to 1 of 7 groups that receive the following before BMT:
  • Groups 1 and 3 – busulfan and fludarabine 
  • Group 2 – fludarabine and TBI
  • Group 4 – fludarabine and melphalan
  • Group 5cyclophosphamide, fludarabine and TBI
  • Group 6 – busulfan and cyclophosphamide
  • Group 7cyclophosphamide and TBI

Before transplant, you’ll get:
  • BusulfanGroups 1, 3 and 6 only – Given as intravenous (IV) infusion or a pill that you take by mouth for 2 or 4 days (depending on your group)
  • Cyclophosphamide Groups 5–7 only – Given as IV infusion for 2 days
  • Fludarabine Groups 1–5 only – Given as IV infusion for 3 or 5 days
  • Melphalan Group 4 only – Given as IV infusion the day before BMT
  • Total body irradiation (TBI) – Groups 2, 5 and 7 only - A treatment done 1 time, the day before transplant 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 infusion for 2 days
  • Mesna – Given as IV infusions for 30 minutes before and 3, 6 and 8 hours after cyclophosphamide
  • Mycophenolate mofetil – Given as IV infusion or a pill that you take by mouth starting 5 days after BMT
  • Tacrolimus – Given as IV infusions or a pill that you take by mouth starting 5 days after BMT

The clinical trial doctors will check your health for up to 1 year. 

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

Contacts


Erin Leckrone, 763-406-5124, eleckron@nmdp.org

Janelle Olson, PhD, 763-406-8147, jolson@nmdp.org

Locations

City of Hope National Medical CenterRecruiting

Duarte, California
Monzr Al Malki, MD

H. Lee Moffitt Cancer Center and Research InstituteRecruiting

Tampa, Florida
Farhad Khimani, MD

University of Florida Health Shands HospitalRecruiting

Gainesville, Florida
Nosha Farhadfar, MD

University of Miami Sylvester Cancer CenterRecruiting

Miami, Florida
Antonio M Jimenez Jimenez, MD

Children's Healthcare of AtlantaRecruiting

Atlanta, Georgia
Muna Qayed, MD

University of Maryland Medical CenterRecruiting

Baltimore, Maryland
Nancy Hardy, MD

Dana Farber Cancer InstituteRecruiting

Boston, Massachusetts
Mahasweta Gooptu, MD

Mayo Clinic RochesterRecruiting

Rochester, Minnesota
William Hogan, MD

Washington University/Barnes Jewish HospitalRecruiting

Saint Louis, Missouri
Ramzi Abboud, MD

Memorial Sloan Kettering Cancer CenterRecruiting

New York, New York
Brian Shaffer, MD

University of North Carolina Chapel HillRecruiting

Chapel Hill, North Carolina
Katarzyna Jamieson, MD

Ohio State Medical Center, James Cancer CenterRecruiting

Columbus, Ohio
Contacts:

  • Karilyn Larkin, MD
  • Hannah Choe, MD

Oregon Health and Science UniversityRecruiting

Portland, Oregon
Levanto Schachter, DO

Thomas Jefferson University Sidney Kimmel Cancer CenterRecruiting

Philadelphia, Pennsylvania
Usama Gergis, MD

University of PennsylvaniaRecruiting

Philadelphia, Pennsylvania
Alison Loren, MD

Vanderbilt University Medical CenterRecruiting

Nashville, Tennessee
Bhagirathbhai Dholaria, MD

University of VirginiaRecruiting

Charlottesville, Virginia
Karen Ballen, MD

Virginia Commonwealth UniversityRecruiting

Richmond, Virginia
John McCarty, MD

Froedtert & the Medical College of WisconsinRecruiting

Milwaukee, Wisconsin
Saurabh Chhabra, MD

University of Wisconsin Hospital and ClinicRecruiting

Madison, Wisconsin
Aric Hall, MD

ClinicalTrials.gov record


NCT04904588

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