NCT00915811

Pilot Study of Reduced Intensity Haematopoietic Stem Cell Transplantation in Patients With Poor Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukaemia (AML) Utilising Conditioning With Fludarabine, Busulphan and Thymoglobulin

Pilot Study of Reduced Intensity Haematopoietic Stem Cell Transplantation in Patients With Poor Risk Myelodysplastic Syndrome and Acute Myeloid Leukaemia Utilising Conditioning With Fludarabine, Busulphan and Thymoglobulin

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: King's College Hospital NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and feasibility of conditioning with fludarabine, busulphan and thymoglobuline in patients with myelodysplastic syndrome (MDS), myelodysplastic/myeloproliferative disorders (MDS/MPD) or acute myeloid leukaemia (AML) undergoing haematopoietic stem cell allograft with granulocyte colony-stimulating factor (G-CSF)-mobilised peripheral blood stem cells (PBSC) (or bone marrow) from HLA compatible sibling donors.

Conditions

• Myelodysplastic Syndromes
• Leukemia, Myeloid, Acute

Interventions

Type	Name	Description
DRUG	Fludarabine	Fludarabine 30mg/m2 intravenously daily on days -9 to -5 inclusive of stem cell infusion.
DRUG	Busulphan	Busulphan 0.8mg/kg intravenously 6 hourly on days -4 and -3 of stem cell infusion.
DRUG	Thymoglobuline (Anti-thymocyte globulin [rabbit]) - Genzyme	Thymoglobuline will be given intravenously over a minimum of 6 hours for the first two doses and 4 hours for the subsequent doses. Acute side effects of ATG appear to be reduced if a very low dose is given for the first injection. Thymoglobuline 0.5mg/kg iv on day -4, 1.5mg/kg/day on day -3; and 2mg/kg/day iv on day -2 to -1 inclusive.
PROCEDURE	Haematopoietic stem cell infusion	The source of stem cells will be PBSC wherever possible. Patients whose donors decline or are unable to donate PBSC will be transplanted with marrow cells.

Timeline

• Start date: 2007-06-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2009-06-08
• Last updated: 2011-08-17

Locations

1 site across 1 country: United Kingdom