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

Completed

• Conditions: Chronic Myeloid Leukemia; Myeloproliferative Disorders; Acute Myeloid Leukemia; Myelodysplastic Syndrome

• Registration Number: NCT01683123
• Lead Sponsor: Grupo Espanol de trasplantes hematopoyeticos y terapia celular

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.

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2011-06
• Study First Submitted: 2012-09-07
• Study First Submitted QC: 2012-09-10
• Study First Posted: 2012-09-11
• Study Completion: 2012-10
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-16
• Last Update Posted: 2022-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified