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NCT01683123 Clinical Trial

Study With Intravenous Busulfan And Fludarabine Myeloablative Conditioning Regimen For HLA Identical Sibling Donor HSCT

Acute Myeloid Leukemia Clinical Trial

— BUFLU  

Official title:
Phase 2 Study With Intravenous Busulfan And Fludarabine Myeloablative Conditioning For HLA Identical Sibling Allogeneic HSCT In Myeloid Malignancies. Retrospective Analysis.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01683123
Other study ID # get-buf-2010-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2007
Est. completion date October 2012

Study information
Verified date March 2022
Source Grupo Espanol de trasplantes hematopoyeticos y terapia celular
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Analyze the results of conditioning with once-daily dose intravenous busulfan and fludarabine in patients undergoing HLA identical sibling Allogeneic HSCT for myeloid malignancies.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 143
Est. completion date October 2012
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Acute Myeloid Leukemia - Myelodysplastic Syndrome - Myeloproliferative Disorders - Chronic Myeloid Leukemia Exclusion Criteria: - Performance status ECOG>2 - Cardiomyopathy (LVEF <39%) - Pulmonary dysfunction (DLCO<39%) - Hepatic dysfunction Grade >1 - Renal dysfunction Grade >1 (Creatinine > 1.6 mg/dl) - HIV infection - Other active neoplasm

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Grupo Espanol de trasplantes hematopoyeticos y terapia celular
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