Spots Global Cancer Trial Database for Treosulfan-Based Conditioning Regimen Before a Blood or Bone Marrow Transplant for the Treatment of Bone Marrow Failure Diseases (BMT CTN 1904)
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Trial Identification
Brief Title: Treosulfan-Based Conditioning Regimen Before a Blood or Bone Marrow Transplant for the Treatment of Bone Marrow Failure Diseases (BMT CTN 1904)
Official Title: Hematopoietic Cell Transplantation Using Treosulfan-Based Conditioning for the Treatment of Bone Marrow Failure Diseases
Study ID: NCT04965597
Conditions
Interventions
Study Description
Brief Summary: This phase II trial tests whether treosulfan, fludarabine, and rabbit antithymocyte globulin (rATG) work when given before a blood or bone marrow transplant (conditioning regimen) to cause fewer complications for patients with bone marrow failure diseases. Chemotherapy drugs, such as treosulfan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Fludarabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. rATG is used to decrease the body's immune response and may improve bone marrow function and increase blood cell counts. Adding treosulfan to a conditioning regimen with fludarabine and rATG may result in patients having less severe complications after a blood or bone marrow transplant.
Detailed Description: OUTLINE: CONDITIONING REGIMEN: Patients receive treosulfan intravenously (IV) over 120 minutes on days -6 to -4, fludarabine phosphate IV over 60 minutes on days -6 to -2, and lapine T-lymphocyte immune globulin (rATG) IV over 4-6 hours on days -4 to -2. TRANSPLANTATION: Patients undergo bone marrow or peripheral blood stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously beginning on day -2 and a taper beginning on day 180. Patients may also receive tacrolimus orally (PO). Patients also receive methotrexate IV on days 1, 3, 6, and 11. Patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening and undergo bone marrow biopsy and aspiration at baseline and follow up. Patients may optionally undergo blood sample collection throughout the trial. After completion of study treatment, patients are followed up at 1 year from transplant.
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital Los Angeles, Los Angeles, California, United States
Rady Children's Hospital/UCSD, San Diego, California, United States
University of California San Francisco, San Francisco, California, United States
Children's Hospital Colorado, Aurora, Colorado, United States
Children's Healthcare of Atlanta, Atlanta, Georgia, United States
Johns Hopkins University, Baltimore, Maryland, United States
Boston Children's Hospital, Boston, Massachusetts, United States
University of Michigan Medical Center, Ann Arbor, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
St. Louis Children's Hospital, Saint Louis, Missouri, United States
Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Cohen Children's Hospital of NY, Queens, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Cincinnati Children's Hospital, Cincinnati, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Oregon Health & Science University, Portland, Oregon, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Texas Children's Hospital, Houston, Texas, United States
Primary Children's/University of Utah, Salt Lake City, Utah, United States
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States
Medical College of Wisconsin/Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Lauri Burroughs, MD
Affiliation: Fred Hutch/University of Washington Cancer Consortium
Role: STUDY_CHAIR
Name: Margaret MacMillan, MD
Affiliation: University of Minnesota
Role: STUDY_CHAIR
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