Myelodysplastic Syndrome Acute myeloid leukaemia MedDRA version: 8.1 Level: HLT Classification code 10028536 Term: Myelodysplastic syndromes
Conditions
Interventions
Trade Name: Fludara®
Pharmaceutical Form: Powder for solution for infusion
Trade Name: Busilvex
Pharmaceutical Form: Solution for infusion
Trade Name: Thymoglobuline
Pharmaceutical Form: Powder for
Sponsors
King's College Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. Cardiac insufficiency requiring treatment or symptomatic coronary artery disease. 2. Hepatic disease, with AST > 2 times normal. 3. Severe hypoxaemia, pO2 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 G-CSF-mobilised PBSC (or bone marrow) from HLA compatible sibling donors;Secondary Objective: 1. Incidence of single or multi-organ acute toxicity 2. Incidence of graft failure/rejection 3. Incidence of acute graft-versus-host disease 4. Incidence of systemic infections 5. EBV activation as described 6. Overall survival 7. Disease free survival/relapse risk ;Primary end point(s): Primary endpoint: 1. Treatment related mortality to Day 100 | — |
Countries
United Kingdom
Outcome results
None listed