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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01683123
Acronym
BUFLU
Enrollment
143
Registered
2012-09-11
Start date
2007-07-31
Completion date
2012-10-31
Last updated
2022-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia, Chronic Myeloid Leukemia, Myelodysplastic Syndrome, Myeloproliferative Disorders

Keywords

Allogeneic HSCT, Busulfan, Fludarabina

Brief 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.

Detailed 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.

Interventions

None listed

Sponsors

Grupo Espanol de trasplantes hematopoyeticos y terapia celular
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026