Trial of Allogeneic BMT for Hematologic Malignancies Using HLA-matched Related or Unrelated Donors With Fludarabine and IV Busulfan as Pre-transplant Conditioning Followed by Post-transplant Immunosuppression With High-dose Cyclophosphamide
Sponsor study identifier
Secondary identifiers
OTHER · JHMIRB
interventional
92
1 country
3
Study Start
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2011
Actual (reported)Study Completion
December 2011
Actual (reported)The purpose of this research is to find the most effective and least toxic way to prevent GVHD after BMT.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2011
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 16, 2008
Actual (reported)December 17, 2008
Actual (reported)May 2009
Date type not reportedThis date has not been verified as actual or estimated.
December 2011
Actual (reported)December 2011
Actual (reported)January 19, 2015
Actual (reported)To Determine the Optimal Regimen of Post-graft Immunosuppression With High-dose Cy Following Fludarabine, Busulfan, and Transplantation of Fully HLA-matched Bone Marrow That Leads to an Acceptable Incidence of Grades III/IV Acute GVHD
Percentage of participants with grade III-IV acute graft versus host disease (GVHD). GVHD is graded on a combination of skin symptoms (rash), gut symptoms (diarrhea), and liver symptoms (using a lab test called bilirubin). Grades range from I to IV, where I is the least severe and IV is the most severe.
1 year
Busulfan once a day for 4 days Fludarabine once a day for 4 days Bone marrow transplant Cytoxan two doses
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Busulfan, Fludarabine, Cytoxan
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordThe Sydney Kimmel Comprehensive Cancer center
Baltimore, Maryland, 21231, United States
Marcos deLima, MD
Houston, Texas, 77030, United States
Paul V. O'Donnell, M.D., Ph.D.
Seattle, Washington, 98109, United States
Kanakry CG, O'Donnell PV, Furlong T, de Lima MJ, Wei W, Medeot M, Mielcarek M, Champlin RE, Jones RJ, Thall PF, Andersson BS, Luznik L. Multi-institutional study of post-transplantation cyclophosphamide as single-agent graft-versus-host disease prophylaxis after allogeneic bone marrow transplantation using myeloablative busulfan and fludarabine conditioning. J Clin Oncol. 2014 Nov 1;32(31):3497-505. doi: 10.1200/JCO.2013.54.0625. Epub 2014 Sep 29.
Leo Luznik, MD
Johns Hopkins University
92 participants (actual enrollment reported by the registry).
First Submitted
December 16, 2008
First Posted
December 17, 2008
Study Start
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2011
Actual (reported)Study Completion
December 2011
Actual (reported)Last Updated
February 16, 2015
Results First Posted
January 19, 2015
Record last verified: 2015-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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