Status:
TERMINATED
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
Lead Sponsor:
King's College Hospital NHS Trust
Conditions:
Myelodysplastic Syndromes
Leukemia, Myeloid, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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/mye...
Eligibility Criteria
Inclusion
- Patient Selection
- Availability of a HLA compatible sibling donor
- Age \>18 years
- Myelodysplastic Syndromes with IPSS Intermediate-2 or High.
- Poor risk acute myeloid leukaemia, de novo or transformed from MDS
- Ineligibility for standard conditioning allograft due to age or co-existing morbidities
- Donor selection
- 1\. Related donors compatible for HLA-A, B, C, DRB1 and DQB1 by molecular typing.
Exclusion
- Patient selection
- Cardiac insufficiency requiring treatment or symptomatic coronary artery disease.
- Hepatic disease, with AST \> 2 times normal.
- Severe hypoxaemia, pO2 \< 70 mm Hg, with decreased DLCO \< 70% of predicted; or mild hypoxemia, pO2 \< 80 mm Hg with severely decreased DLCO \< 60% of predicted.
- Impaired renal function (creatinine \> 2 times upper limit of normal or creatinine clearance \< 50% for age, gender, weight).
- Patients who have received previous treatment with Thymoglobuline
- HIV-positive patients.
- Female patients who are pregnant or breast feeding due to risks to foetus from conditioning regimen and potential risks to nursing infants.
- Life expectancy severely limited by diseases other than MDS or MPD.
- Serious concurrent untreated infection
- Patients with limited life expectancy for other reasons
- Serious psychiatric/ psychological disorders
- Absence of /inability to provide informed consent
- Donor selection
- Age \>75 years, unless independently assessed to be medically fit to donate
- Donors who for any reason are unable to tolerate the leukapheresis procedure and cannot undergo anaesthesia for marrow harvest.
- Donors who are HIV-positive, or hepatitis B or C PCR positive.
- Donors who are medically unsuitable to donate
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00915811
Start Date
June 1 2007
End Date
June 1 2011
Last Update
August 17 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS