Study With Intravenous Busulfan And Fludarabine Myeloablative Conditioning Regimen For HLA Identical Sibling Donor HSCT (BUFLU)
|ClinicalTrials.gov Identifier: NCT01683123|
Recruitment Status : Unknown
Verified September 2012 by Grupo Espanol de trasplantes hematopoyeticos y terapia celular.
Recruitment status was: Active, not recruiting
First Posted : September 11, 2012
Last Update Posted : September 11, 2012
|Condition or disease|
|Acute Myeloid Leukemia Myelodysplastic Syndrome Myeloproliferative Disorders Chronic Myeloid Leukemia|
In this study the investigators evaluate a conditioning regimen consisting in Fludarabine 40 mg/m2 once daily i.v in 60 min. on days -6 to -3 (total dose 160 mg/m2), followed by Busulfan 3,2 mg/kg once daily i.v. in 180 min. in the same days (total dose 12,8 mg/kg). No busulfan pharmacokinetic monitoring is performed. Graft versus host disease prophylaxis consists in the combination of cyclosporine and methotrexate. Graft products obtained from bone marrow or peripheral blood of HLA identical sibling donors are not manipulated in their cellular content before transplantation. Blood products were leukocyte depleted and irradiated before transfusion. Supportive care, including seizure prophylaxis, isolation measures, antiemetics, antimicrobial agents and growth factors use are followed according to standard procedures.
The main objectives are to record data regarding engraftment, regimen related toxicity and outcome in different patient populations according to age, disease type, disease status at HSCT and comorbidities.
|Study Type :||Observational|
|Actual Enrollment :||143 participants|
|Official Title:||Phase 2 Study With Intravenous Busulfan And Fludarabine Myeloablative Conditioning For HLA Identical Sibling Allogeneic HSCT In Myeloid Malignancies. Retrospective Analysis.|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||June 2011|
|Estimated Study Completion Date :||October 2012|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683123
|Principal Investigator:||Javier De la Serna, MD||Grupo Espanol de trasplantes hematopoyeticos y terapia celular|
|Study Chair:||Guillermo Sanz, MD||Grupo Espanol de trasplantes hematopoyeticos y terapia celular|