Multi-center, Open Label, Randomized Trial Comparing Single Versus Double Umbilical Cord Blood (UCB) Transplantation in Pediatric Patients With High Risk Leukemia and Myelodysplasia (BMT CTN #0501)
Sponsor study identifier
Secondary identifiers
NIH
NIH
interventional
224
3 countries
38
Study Start
December 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2014
Actual (reported)Study Completion
October 2014
Actual (reported)This study is a Phase III, randomized, open-label, multi-center, prospective study of single umbilical cord blood (UCB) transplantation versus double UCB transplantation in pediatric patients with hematologic malignancies.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2006
Date type not reportedThis date has not been verified as actual or estimated.
December 14, 2006
Actual (reported)December 18, 2006
Actual (reported)March 2014
Actual (reported)October 2014
Actual (reported)December 21, 2015
Actual (reported)Percentage of Participants With Overall Survival
Overall survival is defined as survival of death from any cause.
1 year post-randomization
Percentage of Participants With Disease-free Survival
1 year post-randomization
Percentage of Participants With Neutrophil and Platelet Engraftment
Days 42 and 100
Unrelated donor, single umbilical cord blood unit transplant; conditioning regimen: Total Body Irradiation/cyclophosphamide/fludarabine; GVHD prophylaxis: Cyclosporine A/Mycophenolate Mofetil
Unrelated donor, double umbilical cord blood unit transplant; Conditioning regimen: Total Body Irradiation/cyclophosphamide/fludarabine; GVHD prophylaxis: Cyclosporine A/Mycophenolate Mofetil
Unrelated donor, single umbilical cord blood unit; conditioning regimen: TBI/cyclophosphamide/fludarabine; GVHD prophylaxis: cyclosporine/MMF
Unrelated donor, double umbilical cord blood unit; Conditioning regimen: TBI/cyclophosphamide/fludarabine; GVHD prophylaxis: cyclosporine/MMF
University of Alabama
Birmingham, Alabama, 35294, United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
Childrens Hospital at Oakland
Oakland, California, 94609, United States
UCSD/Rady Childrens Hospital
San Diego, California, 92123, United States
University of California, San Francisco (Peds)
San Francisco, California, 94143, United States
The Children's Hospital of Denver
Denver, Colorado, 80218, United States
Shulman HM, Sullivan KM, Weiden PL, McDonald GB, Striker GE, Sale GE, Hackman R, Tsoi MS, Storb R, Thomas ED. Chronic graft-versus-host syndrome in man. A long-term clinicopathologic study of 20 Seattle patients. Am J Med. 1980 Aug;69(2):204-17. doi: 10.1016/0002-9343(80)90380-0.
Wagner JE Jr, Eapen M, Carter S, Wang Y, Schultz KR, Wall DA, Bunin N, Delaney C, Haut P, Margolis D, Peres E, Verneris MR, Walters M, Horowitz MM, Kurtzberg J; Blood and Marrow Transplant Clinical Trials Network. One-unit versus two-unit cord-blood transplantation for hematologic cancers. N Engl J Med. 2014 Oct 30;371(18):1685-94. doi: 10.1056/NEJMoa1405584.
Mary Horowitz, MD, MS
Center for International Blood and Marrow Transplant Research
224 participants (actual enrollment reported by the registry).
First Submitted
December 14, 2006
First Posted
December 18, 2006
Study Start
December 2006
Date type not reportedThis date has not been verified as actual or estimated.
Time to Neutrophil and Platelet Engraftment
2 years post-transplant
Percentage of Participants With Acute Graft-versus-host Disease (GVHD)
Day 100 post-randomization
Percentage of Participants With Chronic GVHD
1 year post-randomization
The TBI will be delivered from either a linear accelerator or cobalt source at a dose rate of between 4 and 26 cGy/minute using energies of between 1 and 25 MV.
Cyclophosphamide 60 mg/kg/day will be administered as a 2 hour intravenous infusion with a high volume fluid flush on Days -3 and -2.
Fludarabine 25 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days -10 through -8. Fludarabine will not be dose adjusted for body weight.
CSA will be administered beginning on Day -3 and doses will be adjusted to maintain a level of 200-400 ng/mL by TDX method (or 100-250 ng/mL by Tandem MS or equivalent level for other CSA testing methods). CSA can be administered per institutional practice.
MMF will be given at a dose of 1 gram IV q 8 hours if \> 50 kg or 15 mg/kg IV q 8 hours if \< 50 kg beginning the morning of Day -3.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
University of Florida College of Medicine (Shands)
Gainesville, Florida, 32610, United States
Nemours Childrens Clinic
Jacksonville, Florida, 32207, United States
University of Miami
Miami, Florida, 33136, United States
All Children's Hospital
St. Petersburg, Florida, 33710, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322-1062, United States
Indiana University Medical Center
Indianapolis, Indiana, 46202, United States
University of Louisville/Kosiar Children's Hospital
Louisville, Kentucky, 40202, United States
Children's of New Orleans
New Orleans, Louisiana, 70118, United States
DFCI/Children's Hospital of Boston
Boston, Massachusetts, 02115, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
Karmanos Cancer Institute/Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
University of Mississippi
Jackson, Mississippi, 39216, United States
Children's Mercy Hospital and Clinics
Kansas City, Missouri, 64108, United States
New York Medical College
Valhalla, New York, 10595, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205-2696, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-7610, United States
Children's Medical Center of Dallas
Dallas, Texas, 75235, United States
Cook Childrens Medical Center
Fort Worth, Texas, 76104, United States
Texas Transplant Institute
San Antonio, Texas, 78229, United States
Utah BMT/University of Utah Medical School
Salt Lake City, Utah, 84132, United States
Virgina Commonwealth University
Richmond, Virginia, 23298, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53211, United States
Children's Hospital at Westmead
Westmead, New South Wales, 2145, Australia
BC Cancer Agency
Vancouver, British Columbia, V5Z 4E3, Canada
Primary Completion
March 2014
Actual (reported)Study Completion
October 2014
Actual (reported)Last Updated
October 28, 2021
Results First Posted
December 21, 2015
Record last verified: 2021-10
Findings were published in a manuscript.
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Source: ClinicalTrials.gov.
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