NCT01366612|TerminatedPhase 3ResultsDMC
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Lack of Accrual
FLUBUTBI
PRO#1278: A Phase III Study of Fludarabine and Busulfan Versus Fludarabine, Busulfan and Low Dose Total Body Irradiation in Patients Receiving an Allogeneic Hematopoietic Stem Cell Transplant
Sponsor study identifier
Secondary identifiers
OTHER · HMH
interventional
53
1 country
1
Study Start
June 16, 2010
Actual (reported)Primary Completion
August 17, 2020
Actual (reported)Study Completion
August 18, 2020
Actual (reported)This is a single institution study of fludarabine and busulfan versus fludarabine, busulfan and low dose total body irradiation in patients undergoing allogeneic stem cell transplantation. A study population of 80 subjects will be enrolled from The John Theurer Cancer Center at Hackensack University Medical Center. Subjects who are eligible to receive allogeneic hematopoietic stem cell transplantation according to the eligibility criteria will be consented and enrolled. Subjects will be randomly assigned to receive one of 2 conditioning regimen: fludarabine and busulfan, or fludarabine busulfan and low dose total body irradiation (TBI). Subjects will be followed until 1 year post transplantation to assess the relapse rate in each arm and transplant-related toxicity. The combination of fludarabine and busulfan is the current standard of care for patients with myeloid malignancies (AML, CML and other myeloproliferative disorders, or MDS) undergoing allogeneic transplantation at HUMC. In this study we will be comparing in a randomized fashion the standard regimen to a regimen of fludarabine, busulfan and TBI.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 18, 2020
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.
June 16, 2010
Actual (reported)June 2, 2011
Actual (reported)June 6, 2011
Actual (reported)August 17, 2020
Actual (reported)August 18, 2020
Actual (reported)December 16, 2022
Actual (reported)To Compare the Relapse Rate at 1 Year of Patients With Myeloid Malignancies Receiving Each Treatment
1 year
FLUDARABINE AND BUSULFAN
FLUDARABINE, BUSULFAN AND LOW DOSE TOTAL BODY IRRADIATION
Fludarabine 40mg/m2 and Busulfan 130mg/m2 on days -6, -5, -4 and -3 of transplant. rATG on days -3, -2 and -1
Fludarabine 40mg/m2 and Busulfan 130mg/m2 on days -6, -5, -4 and -3 of transplant. rATG on days -3, -2 and -1 TBI 200cGY (as randomized) on day -1
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Fludarabine and Busulfan plus/minus Total Body Irradiation (low dose)
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Fludarabine and Busulfan + Low Dose Total Body Irradiation (LD TBI)
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordJohn Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Muller CI, Ruter B, Koeffler HP, Lubbert M. DNA hypermethylation of myeloid cells, a novel therapeutic target in MDS and AML. Curr Pharm Biotechnol. 2006 Oct;7(5):315-21. doi: 10.2174/138920106778521523.
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Michele Donato, MD
Hackensack Meridian Health
53 participants (actual enrollment reported by the registry).
First Submitted
June 2, 2011
First Posted
June 6, 2011
Study Start
June 16, 2010
Actual (reported)Primary Completion
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.
Martino R, Iacobelli S, Brand R, Jansen T, van Biezen A, Finke J, Bacigalupo A, Beelen D, Reiffers J, Devergie A, Alessandrino E, Mufti GJ, Barge R, Sierra J, Ruutu T, Boogaerts M, Falda M, Jouet JP, Niederwieser D, de Witte T; Myelodysplastic Syndrome subcommittee of the Chronic Leukemia Working Party of the European Blood and Marrow Transplantation Group. Retrospective comparison of reduced-intensity conditioning and conventional high-dose conditioning for allogeneic hematopoietic stem cell transplantation using HLA-identical sibling donors in myelodysplastic syndromes. Blood. 2006 Aug 1;108(3):836-46. doi: 10.1182/blood-2005-11-4503. Epub 2006 Apr 4.
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de Lima M, Anagnostopoulos A, Munsell M, Shahjahan M, Ueno N, Ippoliti C, Andersson BS, Gajewski J, Couriel D, Cortes J, Donato M, Neumann J, Champlin R, Giralt S. Nonablative versus reduced-intensity conditioning regimens in the treatment of acute myeloid leukemia and high-risk myelodysplastic syndrome: dose is relevant for long-term disease control after allogeneic hematopoietic stem cell transplantation. Blood. 2004 Aug 1;104(3):865-72. doi: 10.1182/blood-2003-11-3750. Epub 2004 Apr 15.
Andersson BS, de Lima M, Thall PF, Wang X, Couriel D, Korbling M, Roberson S, Giralt S, Pierre B, Russell JA, Shpall EJ, Jones RB, Champlin RE. Once daily i.v. busulfan and fludarabine (i.v. Bu-Flu) compares favorably with i.v. busulfan and cyclophosphamide (i.v. BuCy2) as pretransplant conditioning therapy in AML/MDS. Biol Blood Marrow Transplant. 2008 Jun;14(6):672-84. doi: 10.1016/j.bbmt.2008.03.009.
Bredeson CN, Zhang MJ, Agovi MA, Bacigalupo A, Bahlis NJ, Ballen K, Brown C, Chaudhry MA, Horowitz MM, Kurian S, Quinlan D, Muehlenbien CE, Russell JA, Savoie L, Rizzo JD, Stewart DA. Outcomes following HSCT using fludarabine, busulfan, and thymoglobulin: a matched comparison to allogeneic transplants conditioned with busulfan and cyclophosphamide. Biol Blood Marrow Transplant. 2008 Sep;14(9):993-1003. doi: 10.1016/j.bbmt.2008.06.009.
Russell JA, Savoie ML, Balogh A, Turner AR, Larratt L, Chaudhry MA, Storek J, Bahlis NJ, Brown CB, Quinlan D, Geddes M, Stewart DA. Allogeneic transplantation for adult acute leukemia in first and second remission with a novel regimen incorporating daily intravenous busulfan, fludarabine, 400 CGY total-body irradiation, and thymoglobulin. Biol Blood Marrow Transplant. 2007 Jul;13(7):814-21. doi: 10.1016/j.bbmt.2007.03.003. Epub 2007 Apr 23.
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Suh HC, Rowley SD, Kaur S, Lukasik B, McKiernan P, Boonstra M, Baker M, DiLorenzo M, Skarbnik A, Voss J, Hampson A, DeAgresta B, Boylan B, Nyirenda T, Vesole DH, Donato ML. Prospective, Randomized, Comparative Study of Myeloablative Fludarabine/Busulfan and Fludarabine/Busulfan/Total Body Irradiation Conditioning in Myeloid Diseases. Cancers (Basel). 2025 Mar 28;17(7):1140. doi: 10.3390/cancers17071140.
August 17, 2020
Actual (reported)Study Completion
August 18, 2020
Actual (reported)Last Updated
April 3, 2026
Results First Posted
December 16, 2022
Record last verified: 2026-03
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Source: ClinicalTrials.gov.
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