Last updated on March 2018

Double Cord Versus Haploidentical (BMT CTN 1101)

Brief description of study

Hematopoietic cell transplants (HCT)are one treatment option for people with leukemia or lymphoma. Family members,unrelated donors or banked umbilical cordblood units with similar tissue type can be used for HCT. This study will compare the effectiveness of two new types of bone marrow transplants in people with leukemia or lymphoma: one that uses bone marrow donated from family members with only partially matched bone marrow; and, one that uses two partially matched cord blood units.

Detailed Study Description

Reduced intensity conditioning (RIC) blood or marrow transplantation (BMT) has allowed older and less clinically fit patients to receive potentially curative treatment with allogeneic HCT for high risk or advanced hematological malignancies. Patients lacking an HLA-matched sibling may receive a graft from a suitably HLA-matched unrelated donor. However, up to a third of patients will not have an HLA-matched sibling or a suitably matched adult unrelated donor (i.e., no more than a mismatch at a single locus). Even when a suitably matched unrelated donor is identified, data from the National Marrow Donor Program (NMDP) indicate that a median of four months is required to complete searches that result in transplantation; thus, some number of patients succumb to their disease while awaiting identification and evaluation of a suitably matched adult unrelated donor.

Single or dual center studies have shown that partially HLA-mismatched related bone marrow (haplo-BM) and unrelated double umbilical cord blood (dUCB) are valuable sources of donor cells for RIC HCT, thus extending this treatment modality to patients who lack other donors. In order to study the reproducibility, and thus, the wider applicability of these two alternative donor strategies, The Blood and Marrow Transplantation Clinical Trials Network (BMT CTN) conducted two parallel multicenter prospective Phase II clinical trials. These two studies evaluated the safety and efficacy of related haplo-BM (BMT CTN 0603) and dUCB (BMT CTN 0604) transplantation after RIC. Both of these alternative donor approaches produced early results similar to that reported with unrelated donor, and even HLA-matched sibling, HCT. These data demonstrate not only the efficacy of both of these approaches, but also that both can be safely exported from the single center setting. Both haplo-BM and dUCB grafts can be obtained rapidly for greater than 90% of patients lacking an HLA-matched donor. This study will test the hypothesis that progression free survival at two years after RIC haplo-BM transplantation is similar to the progression free survival after RIC dUCB transplantation.

Clinical Study Identifier: NCT01597778

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Shin Mineishi, MD

University of Alabama at Birmingham
Birmingham, AL United States
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Melissa Lim

Arizona Cancer Center
Phoenix, AZ United States
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Veena Fauble, MD

Mayo Clinic Phoenix
Phoenix, AZ United States
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Chatchada Karanes, MD

City of Hope National Medical Center
Duarte, CA United States
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Gary Schiller, MD

University of California at Los Angeles
Los Angeles, CA United States
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Andrew Rezvani, MD

Stanford Hospital and Clinics
Stanford, CA United States
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Tara Gregory, MD

Colorado Blood Cancer Institute
Denver, CO United States
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John R Wingard, MD

University of Florida College of Medicine (Shands)
Gainesville, FL United States
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Jamie Garrison

University of Miami
Miami, FL United States
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Yasser Khaled, MD

Florida Hospital Cancer Institute
Orlando, FL United States
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Edmund Waller, MD

Emory University
Atlanta, GA United States
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Lawrence Morris, MD

BMT Program at Northside Hospital
Atlanta, GA United States
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Omar Aljitawi, MD

University of Kansas Hospital
Kansas City, KS United States
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Zartash Gul, MD

University of Kentucky
Lexington, KY United States
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Ephraim Fuchs, MD

Johns Hopkins University
Baltimore, MD United States
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Karen Ballen, MD

DFCI Massachustts General Hospital
Boston, MA United States
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Corey Cutler, MD

DFCI Brigham & Women's Hospital
Boston, MA United States
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Daniel Couriel, MD

University of Michigan Medical Center
Ann Arbor, MI United States
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Voravit Ratanatharathorn, MD

Karmanos Cancer Institute/BMT
Detroit, MI United States
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Claudio Brunstein, MD

Univeristy of Minnesota
Minneapolis, MN United States
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Shahrukh Hasmi

Mayo Clinic Rochester
Rochester, MN United States
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Philip McCarthy, MD

Roswell Park Cancer Institute
Buffalo, NY United States
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Adriana Malone, MD

Mt. Sinai Medical Center
New York, NY United States
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Michael Becker, MD

University of Rochester Medical Center
Rochester, NY United States
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Michael Sehuster, MD

Stony Brook University Medical Center
Stony Brook, NY United States
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Thomas C Shea, MD

University of North Carolina Hospital at Chapel Hill
Chapel Hill, NC United States
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Joanne Kurtzberg, MD

Duke University Medical Center
Durham, NC United States
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Sharon McFadden

Wake Forest University Health Sciences
Winston-Salem, NC United States
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Miguel Islas-Ohlmayer, MD

Jewish Hospital BMT Program
Cincinnati, OH United States
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Hillard Lazarus, MD

University Hospitals of Cleveland, Case Western
Cleveland, OH United States
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Matt Kalaycio, MD

Cleveland Clinic Foundation
Cleveland, OH United States
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Sumithira Vasu, MD

Ohio State / Arthur G. James Cancer Hospital
Columbus, OH United States
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George Selby, MD

University of Oklahoma Medical Center
Oklahoma City, OK United States
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Witold Rybka, MD

Penn State College of Medicine - The Milton S. Hershey Medical Center
Hershey, PA United States
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Elizabeth Hexner, MD

University of Pennsylvania Cancer Center
Philadelphia, PA United States
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Luciano JM Costa, MD, PhD

Medical University of South Carolina
Charleston, SC United States
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Jamie Garrison

Vanderbilt University Medical Center
Nashville, TN United States
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Stefan Ciurea, MD

Univesity of Texas, MD Anderson CRC
Houston, TX United States
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Paul Shaughnessy, MD

Texas Transplant Institute
San Antonio, TX United States
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John McCarty, MD

Virginia Commonwealth University
Richmond, VA United States
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Rachel Salit, MD

Fred Hutchinson Cancer Research Center
Seattle, WA United States
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Michael Craig, MD

West Virginia University
Morgantown, WV United States
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Marcelo Pasquini, MD

Medical College of Wisconsin
Milwaukee, WI United States
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