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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


1 and older

Phase 2

40 Locations


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 all of the drugs used in this trial. 


Erin Leckrone, 763-406-5124,

Janelle Olson, PhD, 763-406-8147,


City of Hope National Medical CenterRecruiting

Duarte, California
Monzr Al Malki, MD

Stanford UniversityRecruiting

Stanford, California
Sally Arai, MD

University of California San FranciscoRecruiting

San Francisco, California
Aaron Logan, MD

Colorado Blood Cancer InstituteRecruiting

Denver, Colorado
Alireza Eghtedar, MD

H. Lee Moffitt Cancer Center and Research InstituteRecruiting

Tampa, Florida
Farhad Khimani, MD

University of Florida Health Shands HospitalRecruiting

Gainesville, Florida
Zenia Al-Mansour, MD

University of Miami Sylvester Cancer CenterRecruiting

Miami, Florida
Antonio M Jimenez Jimenez, MD

Children's Healthcare of AtlantaRecruiting

Atlanta, Georgia
Muna Qayed, MD

Emory University Medical CenterRecruiting

Atlanta, Georgia
Amelia Langston, MD

Northwestern UniversityRecruiting

Chicago, Illinois
Kehinde Adekola, MD

The University of ChicagoRecruiting

Chicago, Illinois
Satyajit Kosuri, MD

The Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsRecruiting

Baltimore, Maryland
Javier Bolanos Meade, MD

University of Maryland Medical CenterRecruiting

Baltimore, Maryland
Nancy Hardy, MD

Dana Farber Cancer InstituteRecruiting

Boston, Massachusetts
Mahasweta Gooptu, MD

Tufts Medical CenterRecruiting

Boston, Massachusetts
Zheng (Frank) Zhou, MD

University of Michigan Medical Center - Mott Children's HospitaActive, not recruiting

Ann Arbor, Michigan

Karmanos Cancer InstituteRecruiting

Detroit, Michigan
Dipenkumar Modi, MD

Mayo Clinic RochesterRecruiting

Rochester, Minnesota
William Hogan, MD

Washington University/Barnes Jewish HospitalRecruiting

Saint Louis, Missouri
Ramzi Abboud, MD

Columbia University Medical CenterRecruiting

New York, New York
Ran Reshef, MD

Memorial Sloan Kettering Cancer CenterRecruiting

New York, New York
Brian Shaffer, MD

Roswell Park Comprehensive Cancer CenterRecruiting

Buffalo, New York
Philip McCarthy, MD

Levine Cancer InstituteRecruiting

Charlotte, North Carolina
Michael Grunwald, MD

University of North Carolina Chapel HillRecruiting

Chapel Hill, North Carolina
Katarzyna Jamieson, MD

Cincinnati Children's HospitalRecruiting

Cincinnati, Ohio
Ruby Khoury, MD

Ohio State Medical Center, James Cancer CenterRecruiting

Columbus, Ohio

  • Hannah Choe, MD
  • Karilyn Larkin, MD

Oregon Health and Science UniversityRecruiting

Portland, Oregon
Rachel Cook, MD

Thomas Jefferson University Sidney Kimmel Cancer CenterRecruiting

Philadelphia, Pennsylvania
Usama Gergis, MD

University of PennsylvaniaRecruiting

Philadelphia, Pennsylvania
Alison Loren, MD

Medical University of South CarolinaRecruiting

Charleston, South Carolina
Michelle Hudspeth, MD

TriStar BMTRecruiting

Nashville, Tennessee
Jeremy Pantin, MD

TriStar Medical Group Children's SpecialistsRecruiting

Nashville, Tennessee
Haydar Frangoul

Vanderbilt University Medical CenterRecruiting

Nashville, Tennessee
Bhagirathbhai Dholaria, MD

-Baylor College of Medicine - Texas Children's Hospital and Houston MethodistRecruiting

Houston, Texas
George Carrum

St. David's South Austin Medical CenterRecruiting

Austin, Texas
Aravind Ramakrishnan

Texas Transplant InstituteRecruiting

San Antonio, Texas
Jose Carlos Cruz, 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
Medhi Hamadani, MD

University of Wisconsin Hospital and ClinicRecruiting

Madison, Wisconsin
Aric Hall, MD record

NCT04904588. First posted on 5/27/21

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