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 Thymoglobuline

Phase 1

Conditions: Myelodysplastic SyndromeAcute myeloid leukaemia
MedDRA version: 8.1Level: HLTClassification code 10028536Term: Myelodysplastic syndromes

Registration Number: EUCTR2006-004452-20-GB

Lead Sponsor: King's College Hospital NHS Foundation Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.Availability of a HLA compatible sibling donor
2.Age >18 years
3.Myelodysplastic Syndromes with IPSS Intermediate-2 or High.
4.Poor risk acute myeloid leukaemia, de novo or transformed from MDS
5.Ineligibility for standard conditioning allograft due to age or co-existing morbidities

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Cardiac insufficiency requiring treatment or symptomatic coronary artery disease.
2.Hepatic disease, with AST > 2 times normal.
3.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.
4.Impaired renal function (creatinine > 2 times upper limit of normal or creatinine clearance < 50% for age, gender, weight).
5.Patients who have received previous treatment with Thymoglobuline
6.HIV-positive patients.
7.Female patients who are pregnant or breast feeding due to risks to foetus from conditioning regimen and potential risks to nursing infants.
8.Life expectancy severely limited by diseases other than MDS or MPD.
9.Serious concurrent untreated infection
10.Patients with limited life expectancy for other reasons
11.Serious psychiatric/ psychological disorders
12.Absence of /inability to provide informed consent